VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

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

Incidents per State

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

ID: 1245435
Sex: M
Age: 75
State: AL

Vax Date: 03/12/2021
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
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: high blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included Cataract. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to HYPERTENSION. At the time of the report, HYPERTENSION (high blood pressure) was resolving. The patient initially was scheduled for cataract surgery but was hospitalized for high blood pressure The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient takes blood thinners from an unknown date. No treatment information was reported. This case was linked to MODERNATX, INC.-MOD-2021-077862 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded MODERNATX, INC.-MOD-2021-077862:

Other Meds:

Current Illness:

ID: 1245436
Sex: F
Age:
State: OH

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 04/23/2021
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: couldn't sleep; Felt sick; Fell; Body went stiff; Hit head on the wall; Vomiting; Fainted; Had seizures twice; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) and SEIZURE (Had seizures twice) in a 24-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in October 2020. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Back pain). On 03-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), SEIZURE (Had seizures twice) (seriousness criterion medically significant), INSOMNIA (couldn't sleep), MALAISE (Felt sick), FALL (Fell), MUSCULOSKELETAL STIFFNESS (Body went stiff), HEAD INJURY (Hit head on the wall) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Fainted), SEIZURE (Had seizures twice), BACK PAIN (Back pain), INSOMNIA (couldn't sleep), MALAISE (Felt sick), FALL (Fell), MUSCULOSKELETAL STIFFNESS (Body went stiff), HEAD INJURY (Hit head on the wall) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Labs included Electrocardiogram: and Urine analysis, no test results provided. Treatment information not provided. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1245437
Sex: F
Age:
State: MI

Vax Date: 03/26/2021
Onset Date: 03/28/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COVID Pneumonitis; fever; chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (COVID Pneumonitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID Pneumonitis) (seriousness criterion medically significant), PYREXIA (fever) and CHILLS (chills). At the time of the report, COVID-19 PNEUMONIA (COVID Pneumonitis), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Symptoms included dyspnea and Hypoxemia DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: 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. Treatment medications were antibiotics given intramuscularly and orally, albuterol, steroids and her respiratory status was monitored at home. Patient wanted to know if she can still get her second dose. Concomitant medications were not 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.; 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: 1245438
Sex: F
Age: 85
State: MO

Vax Date: 02/09/2021
Onset Date: 03/14/2021
Rec V Date: 04/23/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MALAISE (Feeling unwell). On 15-Mar-2021, the patient experienced CHEST PAIN (Chest pain/right upper quadratic thoracic pain). On 15-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion hospitalization), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was hospitalized on 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain/right upper quadratic thoracic pain), MALAISE (Feeling unwell), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17 Mar 2021 the patient had an x-ray and EKG performed because she was not feeling well and had chest pain- no results provided. On15 Apr 2021 the patient went to emergency room and was hospitalized for multiple pulmonary embolisms with parts being infracted. No treatment information was provided. No relevant concomitant medications were reported. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the 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: 1245439
Sex: F
Age:
State:

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Could not sleep; Agitated; Itching at injection site; Redness at the injection site; Swelling at the injection site; Auditory hallucinations; felt irritable; Angry; felt confused like i was having some kind of cognitive thing; I experience fear along with paranoia; I experience fear along with paranoia; underlying diplopia increased; felt uncharacteristically emotional; joint pain in both hips; episode of hard sneezing; tinnitus/ increased and spiked throughout the day; Became fatigued; temperature rose to 102DF; Mild headache/ headache soreness; Sore arm; Increased sinus congestion; brain fog; Imbalance/ Imbalance worse; urinary incontinence x 3 episodes; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, AUDITORY (Auditory hallucinations) in a female patient of an unknown age who received mRNA-1273 (batch no. 019b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mast cell activation syndrome and Diplopia. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SINUS CONGESTION (Increased sinus congestion), FEELING ABNORMAL (brain fog), BALANCE DISORDER (Imbalance/ Imbalance worse), URINARY INCONTINENCE (urinary incontinence x 3 episodes), ASTHENIA (felt weak), FATIGUE (Became fatigued), PYREXIA (temperature rose to 102DF) and HEADACHE (Mild headache/ headache soreness). On 02-Apr-2021, the patient experienced SNEEZING (episode of hard sneezing), TINNITUS (tinnitus/ increased and spiked throughout the day) and ARTHRALGIA (joint pain in both hips). On 03-Apr-2021, the patient experienced HALLUCINATION, AUDITORY (Auditory hallucinations) (seriousness criterion medically significant), IRRITABILITY (felt irritable), ANGER (Angry), CONFUSIONAL STATE (felt confused like i was having some kind of cognitive thing), FEAR (I experience fear along with paranoia), PARANOIA (I experience fear along with paranoia), DIPLOPIA (underlying diplopia increased), EMOTIONAL DISTRESS (felt uncharacteristically emotional), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On 04-Apr-2021, the patient experienced INSOMNIA (Could not sleep) and AGITATION (Agitated). On 02-Apr-2021, URINARY INCONTINENCE (urinary incontinence x 3 episodes), ASTHENIA (felt weak), SNEEZING (episode of hard sneezing) and HEADACHE (Mild headache/ headache soreness) had resolved. On 04-Apr-2021, TINNITUS (tinnitus/ increased and spiked throughout the day), IRRITABILITY (felt irritable), ANGER (Angry), CONFUSIONAL STATE (felt confused like i was having some kind of cognitive thing), FEAR (I experience fear along with paranoia), PARANOIA (I experience fear along with paranoia), DIPLOPIA (underlying diplopia increased), ARTHRALGIA (joint pain in both hips), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, HALLUCINATION, AUDITORY (Auditory hallucinations), PAIN IN EXTREMITY (Sore arm), SINUS CONGESTION (Increased sinus congestion), FEELING ABNORMAL (brain fog), BALANCE DISORDER (Imbalance/ Imbalance worse), AGITATION (Agitated), FATIGUE (Became fatigued) and PYREXIA (temperature rose to 102DF) outcome was unknown and EMOTIONAL DISTRESS (felt uncharacteristically emotional) and INSOMNIA (Could not sleep) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) 102. On 01-Apr-2021, Heart rate: 74 (Inconclusive) 74. On 02-Apr-2021, Body temperature: 99.4 (Inconclusive) 99.4. On 02-Apr-2021, Heart rate: 64 (Inconclusive) 64. Treatment information for the events were 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.

Other Meds:

Current Illness:

ID: 1245440
Sex: M
Age: 64
State: FL

Vax Date: 03/24/2021
Onset Date: 04/08/2021
Rec V Date: 04/23/2021
Hospital: Y

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: blood clots; his arm felt sore, almost like he had just received the vaccine; doctor thinks it has something to do with the heart; low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced THROMBOSIS (blood clots) (seriousness criterion hospitalization), PAIN IN EXTREMITY (his arm felt sore, almost like he had just received the vaccine), CARDIAC DISORDER (doctor thinks it has something to do with the heart) and HYPOTENSION (low blood pressure). The patient was hospitalized on 08-Apr-2021 due to THROMBOSIS. At the time of the report, THROMBOSIS (blood clots), PAIN IN EXTREMITY (his arm felt sore, almost like he had just received the vaccine) and CARDIAC DISORDER (doctor thinks it has something to do with the heart) had not resolved and HYPOTENSION (low blood pressure) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. On 08 Apr 2021, the patient's arm felt sore, "almost like he had just received the vaccine". He went to urgent care, and they sent him to the hospital and he was admitted. The patient said his doctor thinks the blood clots had something to do with the heart. The patient thought it had to do with the vaccine because he has "always been healthy" and never had any heart problems. The patient was still in the hospital at the time of this report. 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. Doctor thinks "thrombosis" has something to do with the heart

Other Meds:

Current Illness:

ID: 1245441
Sex: F
Age: 50
State: MI

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Temperature of 95F, hypothermia; Diarrhea; left eye was twitching; Finger in the left and right hand where blue; Vomiting; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Temperature of 95F, hypothermia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Relevant medical history was not reported). On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (sore arm). On 10-Apr-2021, the patient experienced CHILLS (Chills). On 11-Apr-2021, the patient experienced HYPOTHERMIA (Temperature of 95F, hypothermia) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue) and VOMITING (Vomiting). At the time of the report, HYPOTHERMIA (Temperature of 95F, hypothermia), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue), LIMB DISCOMFORT (sore arm), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not reported. Treatment for the events included acetaminophen and naproxen. It was noted that the patient's HCP was aware of her symptoms. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1245442
Sex: M
Age: 47
State: FL

Vax Date: 04/11/2021
Onset Date: 04/16/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. 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 this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1245443
Sex: M
Age: 67
State: FL

Vax Date: 03/11/2021
Onset Date: 04/14/2021
Rec V Date: 04/23/2021
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: extremly high blood pressure; severe headache; DVT to right leg starting at the groin and going down to the foot; worsen edema with 4+and 5+ pitting edema in right leg; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) 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 provided.). Concomitant products included DUPILUMAB (DUPIXENT) from 09-Mar-2021 to 06-Apr-2021 and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg). On an unknown date, the patient experienced HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache). At the time of the report, DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot), OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg), HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Ultrasound Doppler abnormal: abnormal (abnormal) Causative extensive occlusive thrombus", DVT in the right leg starting from the groin going down to the foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had an ultrasound of the leg performed. The diagnosis showed "causative extensive occlusive thrombus". Patient reported taking heparin and acetaminophen(Tylenol) ad treatment for the symptoms. This case was linked to (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. MOD-2021-079102:1st dose

Other Meds: DUPIXENT; CYMBALTA

Current Illness:

ID: 1245444
Sex: M
Age: 77
State: NJ

Vax Date: 02/05/2021
Onset Date: 03/19/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: two large lumps in his right breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (two large lumps in his right breast) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 BREAST MASS (two large lumps in his right breast) (seriousness criterion medically significant). At the time of the report, BREAST MASS (two large lumps in his right breast) outcome was unknown. he noticed "two large lumps in his right breast" and he is "getting surgically removed" No concomitant medications were provided. Treatment medications 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: 1245445
Sex: F
Age:
State: CO

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 04/23/2021
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: Stroke; Complex migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and MIGRAINE (Complex migraine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A.) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and MIGRAINE (Complex migraine) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and MIGRAINE (Complex migraine) outcome was unknown. Company comment:Very limited information regarding these events has been provided at this time. Further information has been requested. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1245446
Sex: F
Age:
State: FL

Vax Date: 03/25/2021
Onset Date: 04/16/2021
Rec V Date: 04/23/2021
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: Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication administered included shingles injection. Treatment information included paracetamol (Tylenol). 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.; 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.

Other Meds:

Current Illness:

ID: 1245447
Sex: F
Age: 56
State: OH

Vax Date: 12/12/2020
Onset Date: 02/21/2021
Rec V Date: 04/23/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: had another stroke; blood clots in brain; Difficult to control right hand; difficult to speak; had a stroke and went to the hospital; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (had another stroke), CEREBRAL THROMBOSIS (blood clots in brain), TRANSIENT ISCHAEMIC ATTACK (had a stroke and went to the hospital), DYSKINESIA (Difficult to control right hand) and DYSARTHRIA (difficult to speak) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 039A20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had a stroke and went to the hospital) (seriousness criterion medically significant). On 23-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had another stroke) (seriousness criteria hospitalization and medically significant), CEREBRAL THROMBOSIS (blood clots in brain) (seriousness criterion hospitalization), DYSKINESIA (Difficult to control right hand) (seriousness criterion hospitalization) and DYSARTHRIA (difficult to speak) (seriousness criterion hospitalization). The patient was hospitalized from 23-Feb-2021 to 26-Feb-2021 due to CEREBRAL THROMBOSIS, CEREBROVASCULAR ACCIDENT, DYSARTHRIA and DYSKINESIA. At the time of the report, CEREBROVASCULAR ACCIDENT (had another stroke), CEREBRAL THROMBOSIS (blood clots in brain), TRANSIENT ISCHAEMIC ATTACK (had a stroke and went to the hospital), DYSKINESIA (Difficult to control right hand) and DYSARTHRIA (difficult to speak) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not reported. Treatment for the events included Plavix.; Sender's Comments: Although a temporal association exist, critical details such as the patient's medical history, list of concomitant medication are lacking . Pending additional information, causality with mRNA-1273 administration cannot be confirmed for all events.

Other Meds:

Current Illness:

ID: 1245448
Sex: M
Age: 56
State: AR

Vax Date: 03/17/2021
Onset Date: 04/15/2021
Rec V Date: 04/23/2021
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: Blood in the stool; Diarrhoea; Stomach cramping; Head ache; Little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in the stool) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 045A21A) 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 adverse event.). Concomitant products included METOPROLOL and LOSARTAN for Blood pressure. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Little dizzy). On 16-Apr-2021, the patient experienced HAEMATOCHEZIA (Blood in the stool) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach cramping) and HEADACHE (Head ache). At the time of the report, HAEMATOCHEZIA (Blood in the stool), DIZZINESS (Little dizzy), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach cramping) and HEADACHE (Head ache) outcome was unknown. Patient stated that he has discharged blood 3 or 4 times more but said it is just a splatter on top of the water and on the paper when clean itself. The patient has no history of gastrointestinal issues or bleeding. Patient had taken 2 Aleve. This case concerns a 56-year-old male with a serious unexpected event of hematochezia, and nonserious unexpected abdominal pain upper, dizziness, diarrhea, and expected headache. Event onset 2 days after second dose mRNA-1273. 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.; Sender's Comments: This case concerns a 56-year-old male with a serious unexpected event of hematochezia, and nonserious unexpected abdominal pain upper, dizziness, diarrhea, and expected headache. Event onset 2 days after second dose mRNA-1273. 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: METOPROLOL; LOSARTAN

Current Illness:

ID: 1245449
Sex: M
Age: 71
State: MA

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 04/23/2021
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: left side of face drooped; Chills; Mild Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side of face drooped) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Mild Sore left arm). On 03-Apr-2021, the patient experienced FACIAL PARALYSIS (left side of face drooped) (seriousness criterion medically significant) and CHILLS (Chills). On 04-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, FACIAL PARALYSIS (left side of face drooped) and PAIN IN EXTREMITY (Mild Sore left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was 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. This case was linked to US-MODERNATX, INC.-MOD-2021-079339 (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-2021-079339:Case for dose 2

Other Meds:

Current Illness:

ID: 1245450
Sex: M
Age: 71
State: MA

Vax Date: 03/06/2021
Onset Date: 04/03/2021
Rec V Date: 04/23/2021
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: Felt left side of face drooped, unable to close left eye, and could not control left side of face; patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bladder disorder. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (OXYBUTININ ACCORD) for Bladder disorder NOS. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) (seriousness criterion medically significant) and CHILLS (patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day). On 04-Apr-2021, CHILLS (patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day) had resolved. At the time of the report, FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) outcome was unknown. Treatment Medications included prednisone 20mg 3 times daily for 4 days, valacyclovir 1 gm tablet 3 times daily for 7 days and artificial tears drops with directions instill 1 to 2 drops every 4 hours to left eye. On 04Apr2021, Emergency room and primary care doctors confirmed that it is Bell's Palsy. As up 16Apr2021, the neurologist assessed and confirmed of Bell's Palsy (severe facial paralysis). Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded. Action taken with mRNA-1273 in response to the events was not Applicable This case was linked to MODERNATX, INC.-MOD-2021-079332 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-079332:Case for dose 1

Other Meds: OXYBUTININ ACCORD

Current Illness: Bladder disorder

ID: 1245451
Sex: F
Age: 65
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: couldn't move; throat closed; couldn't swallow; lethargic; chills; fever; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed) and DYSPHAGIA (couldn't swallow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Caller stated that she had COVID19 last April and she was hospitalized two times because she needed oxygen.) in April 2020 and Cancer (She is recovering from cancer, so she was reluctant to go to the hospital or call her doctor for her side effects.) since an unknown date. On 24-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 MOVEMENT DISORDER (couldn't move) (seriousness criterion hospitalization), THROAT TIGHTNESS (throat closed) (seriousness criterion hospitalization) and DYSPHAGIA (couldn't swallow) (seriousness criterion hospitalization). On an unknown date, the patient experienced LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever). The patient was hospitalized on 01-Apr-2021 due to MOVEMENT DISORDER, then for 4 days due to DYSPHAGIA and THROAT TIGHTNESS. At the time of the report, MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed), DYSPHAGIA (couldn't swallow), LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional 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. Additional information has been requested.

Other Meds:

Current Illness: Cancer (She is recovering from cancer, so she was reluctant to go to the hospital or call her doctor for her side effects.)

ID: 1245452
Sex: M
Age: 37
State: CA

Vax Date: 03/19/2021
Onset Date: 03/21/2021
Rec V Date: 04/23/2021
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: Atrial fibrillation; Thyroid hormone (TSH) goes down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood thyroid stimulating hormone: low (Low) Low. On 21-Mar-2021, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. On 21-Mar-2021, Stress echocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. The patient was in emergency room for few hours and was given 3 doses of apixaban (Eliquis) for treatment for the events. The patient was on holter monitor for 3 days. The patient reported, his thyroid level comes near normal after one and half weeks. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. He is pilot and kept off the duty for Atrial fibrillation.; 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: 1245453
Sex: F
Age: 67
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 04/23/2021
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: Transient global amnesia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT GLOBAL AMNESIA (Transient global amnesia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT GLOBAL AMNESIA (Transient global amnesia) (seriousness criteria hospitalization and disability). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to TRANSIENT GLOBAL AMNESIA. At the time of the report, TRANSIENT GLOBAL AMNESIA (Transient global amnesia) was resolving. Not Provided No concomitant medications were reported. Treatment information was not provided. The patient was fine after first dose, but after second dose, the patient was hospitalized for 3 days and diagnosed with transient global amnesia. It was reported that patient was feeling better. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1245454
Sex: F
Age: 44
State: AR

Vax Date: 03/15/2021
Onset Date: 03/23/2021
Rec V Date: 04/23/2021
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: Small amount of blood clots; Potassium levels dropped; Increased hypertension; dizziness; Arm pain from her elbow to shoulder; Shortness of breath; Blood pressure increased; fatigue; chills; Hear arm was hot to touch; Itchiness; Red circle near injection site the size of a quarter; not to take the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Small amount of blood clots) and HYPOKALAEMIA (Potassium levels dropped) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction. On 15-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 VACCINATION SITE ERYTHEMA (Red circle near injection site the size of a quarter). On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hear arm was hot to touch) and VACCINATION SITE PRURITUS (Itchiness). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain from her elbow to shoulder), DYSPNOEA (Shortness of breath), BLOOD PRESSURE INCREASED (Blood pressure increased), DIZZINESS (dizziness), FATIGUE (fatigue) and CHILLS (chills). On 01-Apr-2021, the patient experienced THROMBOSIS (Small amount of blood clots) (seriousness criterion medically significant), HYPOKALAEMIA (Potassium levels dropped) (seriousness criterion medically significant) and HYPERTENSION (Increased hypertension). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not to take the second dose). At the time of the report, THROMBOSIS (Small amount of blood clots), HYPOKALAEMIA (Potassium levels dropped), PAIN IN EXTREMITY (Arm pain from her elbow to shoulder), DYSPNOEA (Shortness of breath), BLOOD PRESSURE INCREASED (Blood pressure increased), HYPERTENSION (Increased hypertension), VACCINATION SITE WARMTH (Hear arm was hot to touch), DIZZINESS (dizziness), VACCINATION SITE PRURITUS (Itchiness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red circle near injection site the size of a quarter) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not to take the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 01-Apr-2021 patient went to the ER for 2 hours. The HCP at the ER stated she had increased hypertension, potassium levels dropped and there was a small amount of blood clots. Her primary care physician said not to take the second dose. Patient inquired about what she can do to manage her symptoms. Concomitant drugs were not reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information is 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 event, a causal relationship cannot be excluded. However, Further information is requested.

Other Meds:

Current Illness:

ID: 1245455
Sex: F
Age: 74
State: TN

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 04/23/2021
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: Atrial fibrillation for 4 days; condition aggravated; Couldn't stand up straight or walk in a straight line during the atrial fibrillation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included WARFARIN, ATENOLOL and ATORVASTATIN for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant) and GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation). On 16-Apr-2021, GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was treated with Cartia (diltiazem) as advised by their health care professional to try to alleviate the symptoms. 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; 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. cross linked case

Other Meds: WARFARIN; ATENOLOL; ATORVASTATIN

Current Illness:

ID: 1245456
Sex: F
Age: 83
State: FL

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 04/23/2021
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: Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and medical history were not reported. The treatment received in response to the events was unknown. 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: 1245457
Sex: F
Age: 87
State: OK

Vax Date: 02/02/2021
Onset Date: 03/19/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: blisters form after she eats and when they pop they bleed for a while; blood blisters in mouth worse; blisters pop and it hurts; rash gotten worse; 45 days between the administration of the 1st dose and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) in an 87-year-old female patient who received mRNA-1273 (batch nos. 032M20A and 030L20A) 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 previous medical history was provided). On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose). On an unknown date, the patient experienced HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (blood blisters in mouth worse), PAIN (blisters pop and it hurts) and RASH (rash gotten worse). At the time of the report, HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while), PAIN (blisters pop and it hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose) outcome was unknown and ORAL MUCOSAL BLISTERING (blood blisters in mouth worse) and RASH (rash gotten worse) had not resolved. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-079482 (Patient Link).; Sender's Comments: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1245458
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/15/2021
Rec V Date: 04/23/2021
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: Patient passed out and hit head on the ground; Felt horrible when she got up; Shake; Keep getting cold and had chills; Get hot; Hit head on the ground; Patient scrapped knee and knee is burning; Move was excruciating/didn't even roll over and hurt to move; Patient scrapped knee and knee is burning; Felt like she was going to throw up; Hurt real bad, body was very very sore; Keep getting cold and had chills; Joint Sore; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient passed out and hit head on the ground) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No relevant medical history provided). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient passed out and hit head on the ground) (seriousness criterion medically significant), FEELING ABNORMAL (Felt horrible when she got up), TREMOR (Shake), FEELING COLD (Keep getting cold and had chills), FEELING HOT (Get hot), HEAD INJURY (Hit head on the ground), BURNING SENSATION (Patient scrapped knee and knee is burning), PAIN (Move was excruciating/didn't even roll over and hurt to move), JOINT INJURY (Patient scrapped knee and knee is burning), NAUSEA (Felt like she was going to throw up), MYALGIA (Hurt real bad, body was very very sore), CHILLS (Keep getting cold and had chills) and ARTHRALGIA (Joint Sore). At the time of the report, LOSS OF CONSCIOUSNESS (Patient passed out and hit head on the ground), FEELING ABNORMAL (Felt horrible when she got up), TREMOR (Shake), FEELING COLD (Keep getting cold and had chills), FEELING HOT (Get hot), HEAD INJURY (Hit head on the ground), BURNING SENSATION (Patient scrapped knee and knee is burning), PAIN (Move was excruciating/didn't even roll over and hurt to move), JOINT INJURY (Patient scrapped knee and knee is burning), NAUSEA (Felt like she was going to throw up), MYALGIA (Hurt real bad, body was very very sore), CHILLS (Keep getting cold and had chills) and ARTHRALGIA (Joint Sore) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient got extremely hot when using the bathroom. Felt like she was going to throw up. Patient passed out and hit head on the ground. Patient didn't remember doing this. Patient scrapped knee and knee is burning. Patient feels concerned. Happened within a 24 hour period. Starting to feel better. The concomitant medications and treatment details were not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-075794 (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 event, a causal relationship cannot be excluded MOD21-075794:

Other Meds:

Current Illness:

ID: 1245459
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Ischaemic stroke; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (Ischaemic stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was provided.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (Ischaemic stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Reporter mentioned that diagnosis from hospital which included magnetic resonance imaging (MRI), computed tomography (CT scans), and echocardiogram (EKG) did not reveal any signs from where the blood clots were originated. No treatment information was provided by the reporter. 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: 1245460
Sex: F
Age: 73
State: FL

Vax Date: 02/10/2021
Onset Date: 02/13/2021
Rec V Date: 04/23/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: I had a stroke; Blood clot; Speak was bad, couldn't form words, speak was impaired; Missed her dose due to to the decision not to get it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke) and THROMBOSIS (Blood clot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SPEECH DISORDER (Speak was bad, couldn't form words, speak was impaired) and INTENTIONAL DOSE OMISSION (Missed her dose due to to the decision not to get it). On 16-Feb-2021, CEREBROVASCULAR ACCIDENT (I had a stroke) had resolved. At the time of the report, THROMBOSIS (Blood clot) and SPEECH DISORDER (Speak was bad, couldn't form words, speak was impaired) outcome was unknown and INTENTIONAL DOSE OMISSION (Missed her dose due to to the decision not to get it) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient was receiving treatment with clopidogrel (Plavix) 75mg since the stroke (which is a stronger blood thinner TPA drug that resolve the blood clot). Reportedly, the patient was hospitalized for 3 days. Patient also stated that she was nervous about getting her 2nd dose so she missed her dose due to the decision not to get it with regards to the fear of having another stroke. 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; Sender's Comments:

Other Meds:

Current Illness:

ID: 1245461
Sex: F
Age: 71
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: shortness of breath; congestive heart failure; H-pyloria infections in the stomach; fluid around the lungs virus; Missed the second dose due to hospitalization; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) and PLEURAL EFFUSION (fluid around the lungs virus) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported adverse event). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criterion hospitalization), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) (seriousness criteria hospitalization and medically significant), PLEURAL EFFUSION (fluid around the lungs virus) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization). The patient was hospitalized from 13-Mar-2021 to 26-Mar-2021 due to CARDIAC FAILURE CONGESTIVE, DYSPNOEA, HELICOBACTER GASTRITIS and PLEURAL EFFUSION. At the time of the report, DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach), PLEURAL EFFUSION (fluid around the lungs virus) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient missed the second dose due to hospitalization. Concomitant and treatment information not provided. 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.; 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.

Other Meds:

Current Illness:

ID: 1245462
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: neuropathy in feet prior to start worsened and feet felt like boulders during the flare.; aching all over; Fatigue during flare; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.) (seriousness criterion medically significant), PAIN (aching all over) and FATIGUE (Fatigue during flare). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.), PAIN (aching all over) and FATIGUE (Fatigue during flare) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Flare was worsen after second dose and calmed down after Md gave her a steroid shot last week. MEd told her they are unsure if the flare is related to covid or the con-med isn't working because Xeljanz ( Tofacitinib) is been taking for 3 years. Md is concerned about recent study linking xelijanz ( Tofacitinib) and cancer. 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. Action taken with mRNA-1273 in response to the event was 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.

Other Meds: XELJANZ XR

Current Illness:

ID: 1245463
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Potential adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Potential adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (allergic to anesthesia) and Acetylcholinesterase deficiency. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Potential adverse reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Potential adverse reaction) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications taken by the patient were not provided. Reporter's sister had received Moderna's COVID-19 vaccine and she was hospitalized due to reaction and it was reported as not severe. The symptoms had gradually subsided. The patient had an allergic reaction to anesthesia which was life threatening .Patient had stopped breathing and was sent to the hospital and it was found that patient had pseudocholinesterase deficiency.Treatment information was not provided. Very limited information regarding this event has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Acetylcholinesterase deficiency; Drug allergy (allergic to anesthesia)

ID: 1245464
Sex: F
Age: 54
State: CA

Vax Date: 01/26/2021
Onset Date: 02/23/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Trouble standing; Able to walk into the kitchen awkwardly; It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body; Fell into a chair; Felt warm and had a fever of 100.3; Soreness in left arm; Hard to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis (began new DMT, Tysabri, in June 2020, monthly infusion) and Anemia. Concomitant products included IRON for Anemia, NATALIZUMAB (TYSABRI) for Multiple sclerosis, VITAMIN D NOS and CALCIUM, ERGOCALCIFEROL (CALCIUM +D [CALCIUM;ERGOCALCIFEROL]) for an unknown indication. On 26-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in left arm). 23-Feb-2021, the patient experienced INSOMNIA (Hard to sleep). On 24-Feb-2021, the patient experienced FALL (Fell into a chair) and PYREXIA (Felt warm and had a fever of 100.3). On 24-Feb-2021 at 7:00 AM, the patient experienced PARALYSIS (It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body) (seriousness criterion medically significant), DYSSTASIA (Trouble standing) and GAIT DISTURBANCE (Able to walk into the kitchen awkwardly). At the time of the report, PARALYSIS (It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body), PAIN IN EXTREMITY (Soreness in left arm), INSOMNIA (Hard to sleep), DYSSTASIA (Trouble standing), GAIT DISTURBANCE (Able to walk into the kitchen awkwardly), FALL (Fell into a chair) and PYREXIA (Felt warm and had a fever of 100.3) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 100.3 (High) Increased. Treatment information was not provided. Company Comment: This case concerns a 55-year-old female with a serious unexpected event of paralysis, and nonserious unexpected pain in extremity, dysstasia, gait disturbance, fall, insomnia and expected pyrexia. Event onset 2 days after 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. This case was linked to MOD-2021-025381 (Patient Link).; Sender's Comments: This case concerns a 55-year-old female with a serious unexpected event of paralysis, and nonserious unexpected pain in extremity, dysstasia, gait disturbance, fall, insomnia and expected pyrexia. Event onset 2 days after 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: TYSABRI; VITAMIN D NOS; CALCIUM +D [CALCIUM;ERGOCALCIFEROL]; IRON

Current Illness: Anemia; Multiple sclerosis (began new DMT, Tysabri, in June 2020, monthly infusion)

ID: 1245465
Sex: F
Age:
State: OH

Vax Date: 03/25/2021
Onset Date: 04/15/2021
Rec V Date: 04/23/2021
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: COMMON COLD; body aches; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no historical condition reported.). On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-1021, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant). On 15-Apr-2021, the patient experienced NASOPHARYNGITIS (COMMON COLD) and MYALGIA (body aches). At the time of the report, PULMONARY CONGESTION (chest congestion), NASOPHARYNGITIS (COMMON COLD) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1245466
Sex: F
Age: 58
State: NJ

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 04/23/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Dehydration; Stomach pain; Apatite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (Dehydration) and ABDOMINAL PAIN UPPER (Stomach pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis (The patient was hospitalized before due to the Multiple Sclerosis so many time.) since March 2021. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion hospitalization) and APPETITE DISORDER (Apatite). On 14-Apr-2021, ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. At the time of the report, DEHYDRATION (Dehydration) and APPETITE DISORDER (Apatite) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness: Multiple sclerosis (The patient was hospitalized before due to the Multiple Sclerosis so many time.)

ID: 1245467
Sex: F
Age:
State: AZ

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
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: still feels a bit off; Left eye still worries her in that it seems vision is blurry; Still feels tired and "off " not normal; Cheek felt like it was drooping; Painful to lie on it and to raise the arm; leg felt like it was paralyzed or numb; left eye felt like it was drooping; shoulder where she got the shot is still painful; headache for 3 days starting the day of the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MONOPARESIS (leg felt like it was paralyzed or numb) in a female patient of an unknown age who received mRNA-1273 (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 reported adverse event.). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache for 3 days starting the day of the shot). On 03-Apr-2021, the patient experienced MONOPARESIS (leg felt like it was paralyzed or numb) (seriousness criterion medically significant), OCULAR DISCOMFORT (left eye felt like it was drooping), PAIN IN EXTREMITY (Painful to lie on it and to raise the arm), FACIAL DISCOMFORT (Cheek felt like it was drooping) and VACCINATION SITE PAIN (shoulder where she got the shot is still painful). On 19-Apr-2021, the patient experienced MALAISE (still feels a bit off), VISION BLURRED (Left eye still worries her in that it seems vision is blurry) and FATIGUE (Still feels tired and "off " not normal). On 03-Apr-2021, MONOPARESIS (leg felt like it was paralyzed or numb), OCULAR DISCOMFORT (left eye felt like it was drooping) and FACIAL DISCOMFORT (Cheek felt like it was drooping) had resolved. On 04-Apr-2021, HEADACHE (headache for 3 days starting the day of the shot) had resolved. At the time of the report, MALAISE (still feels a bit off), PAIN IN EXTREMITY (Painful to lie on it and to raise the arm), VISION BLURRED (Left eye still worries her in that it seems vision is blurry), FATIGUE (Still feels tired and "off " not normal) and VACCINATION SITE PAIN (shoulder where she got the shot is still painful) outcome was unknown. The action taken with mRNA-1273 (Intramuscular) was unknown. The patient consulted an HCP and spoke to 2 other doctors who concur that the patient should not get the second shot until the patient has been checked out. The new primary has ordered new tests to see if the patient had a TIA or stroke after the shot. Patient is waiting on a phone from the new HCP call to schedule the tests. 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:

Current Illness:

ID: 1245468
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: "I lost hearing in both ears for 20 min, on and off ever since"; "my vision doubled in size"; "It sounds like a buzzing nose, and feels like I'm on a plan and my ears need to pop."; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS TRANSITORY ("I lost hearing in both ears for 20 min, on and off ever since") in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sore throat (Patient reported that her throat was no longer sore at the time of vaccine just "scratchy."). Concomitant products included CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN A-C) from an unknown date to 13-Apr-2021 for Sore throat. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DEAFNESS TRANSITORY ("I lost hearing in both ears for 20 min, on and off ever since") (seriousness criterion medically significant) and DIPLOPIA ("my vision doubled in size"). On an unknown date, the patient experienced TINNITUS ("It sounds like a buzzing nose, and feels like I'm on a plan and my ears need to pop."). On 13-Apr-2021, DIPLOPIA ("my vision doubled in size") had resolved. At the time of the report, DEAFNESS TRANSITORY ("I lost hearing in both ears for 20 min, on and off ever since") and TINNITUS ("It sounds like a buzzing nose, and feels like I'm on a plan and my ears need to pop.") had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Patient had received a negative COVID test on the day of the vaccination.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient denies any treatment related to the events. 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: ROBITUSSIN A-C

Current Illness: Sore throat (Patient reported that her throat was no longer sore at the time of vaccine just "scratchy.")

ID: 1245469
Sex: F
Age:
State: MI

Vax Date: 04/17/2021
Onset Date: 04/18/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: cellulitis site infection; Injection site warm to touch; Injection site is sore; Injection site is swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis site infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Relevant medical history not reported). On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE PAIN (Injection site is sore) and VACCINATION SITE SWELLING (Injection site is swollen). On an unknown date, the patient experienced CELLULITIS (cellulitis site infection) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis site infection), VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE PAIN (Injection site is sore) and VACCINATION SITE SWELLING (Injection site is swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Patient was evaluated by a nurse and an antibiotic was prescribed for treatment of the suspected cellulitis. 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.; 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.

Other Meds:

Current Illness:

ID: 1245470
Sex: F
Age:
State:

Vax Date: 03/23/2021
Onset Date: 04/02/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bacterial bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS BACTERIAL (Bacterial bronchitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history was not reported.). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BRONCHITIS BACTERIAL (Bacterial bronchitis) (seriousness criterion medically significant). At the time of the report, BRONCHITIS BACTERIAL (Bacterial bronchitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and relevant medical history were not reported. The patient received her first dose of the vaccine on 23-Mar-2021. She "got bacterial bronchitis after the second dose starting 02-Apr-2021." This case was linked; Sender's Comments: brother case

Other Meds:

Current Illness:

ID: 1245471
Sex: F
Age: 70
State: DE

Vax Date: 01/22/2021
Onset Date: 02/05/2021
Rec V Date: 04/23/2021
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: cyst on kidney; cyst on pancreas; Hepatitis B; Jaundice; Cyst on liver; started getting ill; 2nd dose not administered within vaccine schedule window; MRI Abnormal; Ultrasound abnormal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice) and CYST (Cyst on liver) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stomach discomfort (Starting back in August 2020 she didn't feel good, had stomach issues off and on.) since August 2020. Concomitant products included LISINOPRIL for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RENAL CYST (cyst on kidney) (seriousness criterion hospitalization), PANCREATIC CYST (cyst on pancreas) (seriousness criterion hospitalization), HEPATITIS B (Hepatitis B) (seriousness criterion hospitalization), JAUNDICE (Jaundice) (seriousness criterion hospitalization), CYST (Cyst on liver) (seriousness criterion hospitalization), MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal). On an unknown date, the patient experienced ILLNESS (started getting ill) and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window). The patient was hospitalized from 05-Feb-2021 to 08-Feb-2021 due to CYST, HEPATITIS B, JAUNDICE, PANCREATIC CYST and RENAL CYST. On 05-Feb-2021, MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal) outcome was unknown. At the time of the report, RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice), CYST (Cyst on liver) and ILLNESS (started getting ill) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Hepatitis B: positive Positive. On 05-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver.. On 05-Feb-2021, Ultrasound scan: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LISINOPRIL

Current Illness: Stomach discomfort (Starting back in August 2020 she didn't feel good, had stomach issues off and on.)

ID: 1245472
Sex: M
Age:
State: MI

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 04/23/2021
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: Bullous pemphigoid; Skull itches as well; Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) 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. Concurrent medical conditions included Drug allergy (Zithromax), Drug allergy (CT scan dye), Drug allergy (Cipro), Drug allergy (Macrolides), Drug allergy (Lansoprazole), Drug allergy (Phenytoin), Drug allergy (Ranitidine), Drug allergy (Sertraline), Drug allergy (Xarelto), Drug allergy (Eliquis) and Drug allergy (Bentyl). Concomitant products included DESMOPRESSIN, DOXAZOSIN, PREDNISONE, LEVOTHYROXINE, LORAZEPAM, LEVETIRACETAM, TRAMADOL, TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE), OMEPRAZOLE, TRIAMCINOLONE, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, ATENOLOL and VITAMIN D3 for an unknown indication. On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant), PRURITUS (Skull itches as well) and RASH PRURITIC (Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed). At the time of the report, PEMPHIGOID (Bullous pemphigoid), PRURITUS (Skull itches as well) and RASH PRURITIC (Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed) outcome was unknown. Not Provided Treatment for the events included increased Hydroxyzine and Vaseline in hair. 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: DESMOPRESSIN; DOXAZOSIN; PREDNISONE; LEVOTHYROXINE; LORAZEPAM; LEVETIRACETAM; TRAMADOL; TESTOSTERONE CYPIONATE; OMEPRAZOLE; TRIAMCINOLONE; ASPIRIN 81; ATORVASTATIN; ATENOLOL; VITAMIN D3

Current Illness: Drug allergy (Zithromax); Drug allergy (Sertraline); Drug allergy (Ranitidine); Drug allergy (Phenytoin); Drug allergy (Macrolides); Drug allergy (Eliquis); Drug allergy (CT scan dye); Drug allergy (Cipro); Drug allergy (Bentyl)

ID: 1245473
Sex: F
Age:
State:

Vax Date: 03/26/2021
Onset Date: 03/27/2021
Rec V Date: 04/23/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Heart complication (was not explained) which needed a medical procedure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) 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 (No reported medical history). On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were unknown. Patient reported she underwent a procedure for an unspecified reason and hung up. Concomitant medications were not reported. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1245474
Sex: F
Age: 71
State: NC

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a few episodes of a-fib; felt like she might black out; felt like her heart was palpitating; stress; headache; could not sleep; burning in her arm, up through her neck and to her chest.; worry; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (a few episodes of a-fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart valve replacement (two artificial heart valves.) since 2004. Concomitant products included WARFARIN SODIUM (COUMADIN) for Heart valve replacement. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.). On 18-Apr-2021, the patient experienced SLEEP DISORDER (could not sleep). On an unknown date, the patient experienced ATRIAL FIBRILLATION (a few episodes of a-fib) (seriousness criterion medically significant), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), ANXIETY (worry), STRESS (stress) and HEADACHE (headache). On 23-Mar-2021, VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (a few episodes of a-fib), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), SLEEP DISORDER (could not sleep), ANXIETY (worry), STRESS (stress) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the events included Acetaminophen. Echogram scheduled on 05 May 21. Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities

Other Meds: COUMADIN

Current Illness: Heart valve replacement (two artificial heart valves.)

ID: 1245475
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: developed more severe arthritis pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (developed more severe arthritis pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis and Drug allergy (Sulfa). 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 RHEUMATOID ARTHRITIS (developed more severe arthritis pain) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (developed more severe arthritis pain) had not resolved. Not Provided Patient states she received 1st COVID vaccine 10 weeks ago, and 2nd COVID vaccine 6 weeks ago. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Drug allergy (Sulfa); Rheumatoid arthritis

ID: 1245476
Sex: M
Age:
State: IL

Vax Date: 02/03/2021
Onset Date: 03/01/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Blood clots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L209) for COVID-19 vaccination. Concurrent medical conditions included Cancer (The patient was in recovery from cancer). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: blood clots (abnormal) Blood clots. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Description: The patient developed blood clots (medically significant) two weeks after receiving his second dose of the vaccine . The patient was in recovery from cancer and was required to have computerized tomography (CT) scans. He had a computerized tomography (CT) scan within two weeks of taking his second dose and the blood clots were discovered. The patient had never had blood clots before. The patient had already been in contact with his oncologist and was prescribed apixaban. 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Cancer (The patient was in recovery from cancer)

ID: 1245477
Sex: M
Age: 84
State: CA

Vax Date: 03/01/2021
Onset Date: 04/12/2021
Rec V Date: 04/23/2021
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: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Pulmonary Fibrosis; Shortness of breath that required oxygen; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Urothelial carcinoma. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath that required oxygen) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced PULMONARY FIBROSIS (Pulmonary Fibrosis) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to DYSPNOEA and PULMONARY FIBROSIS. At the time of the report, PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included were many medications for underlying urothelial cancer. Treatment included for the events was oxygen high flow nasal cannula. 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: Urothelial carcinoma

ID: 1245478
Sex: M
Age: 46
State:

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

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

Lab Data:

Allergies:

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

Symptoms: sever liver problems; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER DISORDER (sever liver problems) in a 46-year-old male patient who received mRNA-1273 (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 13-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced LIVER DISORDER (sever liver problems) (seriousness criteria hospitalization). The patient was hospitalized from 04-Apr-2021 to 07-Apr-2021 due to LIVER DISORDER. At the time of the report, LIVER DISORDER (sever liver problems) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, COVID-19: negative (Negative) Negative. mRNA-1273 (Intramuscular) was withdrawn on an unknown date. No concomitant medications reported. Treatment of this event was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1245479
Sex: F
Age: 63
State: NC

Vax Date: 03/25/2021
Onset Date: 04/02/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: pneumonia; sore back maybe from coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (sore back maybe from coughing). On 03-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) and BACK PAIN (sore back maybe from coughing) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient's treatment included Prednisone 20mg 2pills for 5 days, Doxycycline 100mg twice a day for 10 days and Cefuroxime 500mg twice a day for 7 days.

Other Meds:

Current Illness:

ID: 1245480
Sex: M
Age: 59
State: TX

Vax Date: 03/09/2021
Onset Date: 04/14/2021
Rec V Date: 04/23/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: sent to the emergency room because his doctor thought he was having a stroke.; blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included DULAGLUTIDE (TRULICITY) for an unknown indication. On 09-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 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) (seriousness criteria hospitalization and medically significant) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to CEREBROVASCULAR ACCIDENT and PURPURA. At the time of the report, CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) outcome was unknown. The lot number of the second vaccine was thought by the patient to be 0L161521A but patient was unsure. The patient was hospitalized for one day due to the events. Magnetic resonance imaging (MRI) and computerized axial tomography (CAT) scan were performed (results not provided). Treatment information was not provided. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-080378, US-MODERNATX, INC.-MOD-2021-080378 (E2B Linked Report). This case was linked to MOD-2021-080340 (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. -MODERNATX, INC.-MOD-2021-080378:Physician case -MODERNATX, INC.-MOD-2021-080378:

Other Meds: TRULICITY

Current Illness:

ID: 1245481
Sex: M
Age: 61
State: IL

Vax Date: 11/16/2020
Onset Date: 03/01/2021
Rec V Date: 04/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ulcerative colitis; lack of drug effect; joint pain; vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 18-Apr-2021. This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (ulcerative colitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included No adverse event (No medical history provided.). On 16-Nov-2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. In March 2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On an unknown date, the patient experienced COLITIS ULCERATIVE (ulcerative colitis) (seriousness criterion medically significant), DRUG INEFFECTIVE (lack of drug effect) and ARTHRALGIA (joint pain). In March 2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. At the time of the report, COLITIS ULCERATIVE (ulcerative colitis), DRUG INEFFECTIVE (lack of drug effect) and ARTHRALGIA (joint pain) 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. 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. Reporter did not allow further contact

Other Meds: Humira

Current Illness:

ID: 1245482
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
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: Transverse myelitis aggravated; She feels her spine is broken in two; Can't walk without pain; This spontaneous case was reported by a consumer and describes the occurrence of DISEASE PROGRESSION (Transverse myelitis aggravated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Myelitis transverse. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DISEASE PROGRESSION (Transverse myelitis aggravated) (seriousness criterion medically significant), SPINAL PAIN (She feels her spine is broken in two) and GAIT DISTURBANCE (Can't walk without pain). At the time of the report, DISEASE PROGRESSION (Transverse myelitis aggravated), SPINAL PAIN (She feels her spine is broken in two) and GAIT DISTURBANCE (Can't walk without pain) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was unknown. Treatment information was not provided. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Myelitis transverse

ID: 1245483
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: grand mal seizures; absence seizures; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) and PETIT MAL EPILEPSY (absence seizures) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Seizures (Patient had a history of seizures but had not had any since a very long time.). 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 GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criterion medically significant) and PETIT MAL EPILEPSY (absence seizures) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) and PETIT MAL EPILEPSY (absence seizures) outcome was unknown. Not Provided Concomitant medication use was not reported. Treatment information was not reported. The patient reported that he had a grand mal seizure approximately 8 hours after the first vaccine dose. Thereafter, the patient stated that he is now averaging 3 -4 seizures per week. The patient endorses that he has never had daytime seizures before. The patient saw his neurologist who said there was no concern and advised that he continue to monitor. The patient stated that he did receive his second dose of the vaccine, dates were not 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. However, patient's hx of seizure is a confounding factor that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's hx of seizure is a confounding factor that may play a possible contributory role.

Other Meds:

Current Illness:

ID: 1245484
Sex: M
Age: 55
State: FL

Vax Date: 03/24/2021
Onset Date: 04/19/2021
Rec V Date: 04/23/2021
Hospital: Y

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: Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LEVOTHYROXINE, IRBESARTAN and LANSOPRAZOLE for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: pneumonia pneumonia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient went to hospital on an unspecified date and x-ray exam showed that he had pneumonia. The patient was prescribed with antibiotics and cough medicine. The patient was to check if doxycycline and promethazine medicine will effect on his second dose schedules on 21-APR-2012. The reporter did not provide an assessment for the event , pneumonia. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: AMLODIPINE; LEVOTHYROXINE; IRBESARTAN; LANSOPRAZOLE

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm