VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1276766
Sex: F
Age: 59
State: TN

Vax Date: 04/19/2021
Onset Date: 04/21/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: blisters in the back of throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (blisters in the back of throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced OROPHARYNGEAL BLISTERING (blisters in the back of throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL BLISTERING (blisters in the back of throat) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Treatment information was not provided. Company Comment: This case concerns a 59-year-old female with a serious unexpected event of oropharyngeal blistering. Event onset 3 days after second dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 59-year-old female with a serious unexpected event of oropharyngeal blistering. Event onset 3 days after second dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1276767
Sex: F
Age: 35
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 05/01/2021
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: Blurred vision "in a tunnel"; Blurred vision "in a tunnel"; Difficulty walking; Dizzy; Tingling in face and mouth; Face felt flushed; Chills; Nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TUNNEL VISION (Blurred vision "in a tunnel") in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), AMPHETAMINE, EPINEPHRINE, AMLODIPINE, NIMODIPINE and ALPRAZOLAM for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced TUNNEL VISION (Blurred vision "in a tunnel") (seriousness criterion medically significant), VISION BLURRED (Blurred vision "in a tunnel"), GAIT DISTURBANCE (Difficulty walking), DIZZINESS (Dizzy), PARAESTHESIA (Tingling in face and mouth), FLUSHING (Face felt flushed), CHILLS (Chills) and NAUSEA (Nauseas). At the time of the report, TUNNEL VISION (Blurred vision "in a tunnel"), VISION BLURRED (Blurred vision "in a tunnel"), GAIT DISTURBANCE (Difficulty walking), DIZZINESS (Dizzy), PARAESTHESIA (Tingling in face and mouth), FLUSHING (Face felt flushed), CHILLS (Chills) and NAUSEA (Nauseas) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, COVID-19: positive (Positive) other. On 22-Feb-2021, COVID-19: negative (Negative) other. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. A few minutes after vaccine administration, the patient became dizzy, nausea, blurred vision "in a tunnel", chills, difficulty walking and tingling in face and mouth. Her face also felt flushed at the time. The patient was then transported by Ambulance to the Emergency Room. At the Emergency Room the patient was treated and discharged. The side effects have improved, but are still present at this time. Treatment medications included lorazepam and ondansetron. Company comment: This case concerns a 35-year-old female with PMH of COVID-19 a serious unexpected event of tunnel vision, and non serious unexpected vision blurred, gait disturbance, dizziness, paresthesia, flushing, and expected chills and nausea. Event onset the same day as first dose mRNA-1273. Events resolving. 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 35-year-old female with PMH of COVID-19 a serious unexpected event of tunnel vision, and nonserious unexpected vision blurred, gait disturbance, dizziness, paraesthesia, flushing, and expected chills and nausea. Event onset the same day as first dose mRNA-1273. Events resolving. 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: ADDERALL; AMPHETAMINE; EPINEPHRINE; AMLODIPINE; NIMODIPINE; ALPRAZOLAM

Current Illness:

ID: 1276768
Sex: F
Age:
State: TX

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 05/01/2021
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: Can't breath; tongue swollen; throat is real red; Itches all over; rash on the upper part of body; Fever; eyes are burning; feels like she got pneumonia; arm felt numb; heada che; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't breath) and SWOLLEN TONGUE (tongue swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma, Bronchitis and Sinusitis. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOAESTHESIA (arm felt numb) and HEADACHE (heada che). On 07-Apr-2021, the patient experienced EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPNOEA (Can't breath) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue swollen) (seriousness criterion life threatening), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over) and RASH (rash on the upper part of body). At the time of the report, DYSPNOEA (Can't breath), SWOLLEN TONGUE (tongue swollen), HYPOAESTHESIA (arm felt numb), EYE IRRITATION (eyes are burning), CHEST DISCOMFORT (feels like she got pneumonia), PHARYNGEAL ERYTHEMA (throat is real red), PRURITUS (Itches all over), RASH (rash on the upper part of body), PYREXIA (Fever) and HEADACHE (heada che) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 98.3 (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient have not taken medical care at the time of report. No treatment information available. advised to seek medical care immediately. 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; 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: Asthma; Bronchitis; Sinusitis

ID: 1276769
Sex: F
Age: 78
State: PA

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Hearing loss; Vertigo; Tinnitus; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (Hearing loss) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was provided by the reporter. On 14-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 DEAFNESS (Hearing loss) (seriousness criteria disability and medically significant), VERTIGO (Vertigo) and TINNITUS (Tinnitus). At the time of the report, DEAFNESS (Hearing loss), VERTIGO (Vertigo) and TINNITUS (Tinnitus) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Patient went to audiologist and was given a hearing aide. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1276770
Sex: F
Age: 47
State: WA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 05/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: very mild heart attack; chest started burning; couldn't breath; incomplete course of vaccination; very sick; arm got little sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (very mild heart attack) in a 47-year-old female 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. Co-suspect product included non-company product SIMVASTATIN for an unknown indication. The patient's past medical history included Allergic reaction (MMR vaccine allergic reaction as an infant) in 1973. Concomitant products included PANTOPRAZOLE, SERTRALINE and VARENICLINE TARTRATE (CHANTIX) for an unknown indication, ACETYLSALICYLATE LYSINE (ASPARIN). On 24-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SIMVASTATIN (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm got little sore). On 25-Mar-2021, the patient experienced ILLNESS (very sick), DYSPNOEA (couldn't breath) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On 25-Mar-2021 at 8:00 AM, the patient experienced MYOCARDIAL INFARCTION (very mild heart attack) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (chest started burning). The patient was hospitalized on 25-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (very mild heart attack), ILLNESS (very sick), CHEST PAIN (chest started burning), DYSPNOEA (couldn't breath), INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) and VACCINATION SITE PAIN (arm got little sore) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Angiogram: normal (normal) no signs of plaque buildup. On 25-Mar-2021, Blood creatinine: abnormal (abnormal) levels determined patient was having a mild heart attack. On 25-Mar-2021, Electrocardiogram: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was very panicky about getting the second dose for fear that she would have another heart attack. She went to the cardiologist for a follow up and the doctor could not determine why she had a heart attack. The patient reported that it was not a normal heart attack in that her blood pressure and pulse were not raised, but instead, were low. The patient agreed to follow up with her HCP (health care provider). Treatment for the heart attack included SIMVASTATIN and BABY ASPIRIN to prevent blood clots. 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: PANTOPRAZOLE; SERTRALINE; CHANTIX; ASPARIN; SIMVASTATIN

Current Illness:

ID: 1276771
Sex: M
Age: 61
State: OR

Vax Date: 03/28/2021
Onset Date: 03/28/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainting) in a 61-year-old male 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. No relevant medical history reported. Concomitant products included LOSARTAN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache). On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Treatment in the ER included "methazine." The patient noted that he will not be getting the second planned vaccine dose. Company Comment: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. 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 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. 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: LOSARTAN; METOPROLOL; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1276772
Sex: F
Age: 55
State: MD

Vax Date: 04/02/2021
Onset Date: 04/23/2021
Rec V Date: 05/01/2021
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: blood in her urine with clots; felt bad like the flu; went to sleep and woke up dizzy; buzzing in her ears; she feels with altitude sickness; Plugged ears; tiredness; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (blood in her urine with clots) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No patient medical history reported. Concomitant products included METOPROLOL for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (blood in her urine with clots) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HAEMORRHAGE URINARY TRACT (blood in her urine with clots), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. Additional concomitant medications included reflux medication when needed and asthma medication when needed. This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. 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 US-MODERNATX, INC.-MOD-2021-090443, US-MODERNATX, INC.-MOD-2021-090371 (E2B Linked Report).; Sender's Comments: This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. 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. US-MODERNATX, INC.-MOD-2021-090443:Dose 1 US-MODERNATX, INC.-MOD-2021-090371:Son's case

Other Meds: METOPROLOL

Current Illness:

Date Died: 04/05/2021

ID: 1276773
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 04/05/2021
Rec V Date: 05/01/2021
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: Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). The patient died on 05-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. Concomitant medications were not reported. The patient was not hospitalized prior to or during the stroke. The reporter mentioned that the organs were donated as the patient was on a ventilator.; Reported Cause(s) of Death: Stroke

Other Meds:

Current Illness:

ID: 1276774
Sex: M
Age: 35
State: NM

Vax Date: 01/09/2021
Onset Date: 01/01/2021
Rec V Date: 05/01/2021
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: Meniere's Disease; ear infection; Autoimmune response to the vaccine; headaches; facial pressure; tinnitus; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENIERE'S DISEASE (Meniere's Disease) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced FACIAL DISCOMFORT (facial pressure), TINNITUS (tinnitus) and HEADACHE (headaches). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's Disease) (seriousness criterion medically significant), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine). At the time of the report, MENIERE'S DISEASE (Meniere's Disease), FACIAL DISCOMFORT (facial pressure), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine) outcome was unknown and TINNITUS (tinnitus) and HEADACHE (headaches) had not resolved. On unknown date, the patient was given antibiotics for a possible ear infection and the ears, nose and throat (ENT) physician put the patient on prednisone. On unknown date, the patient was seen by a neurologist for the persistent headaches and tinnitus and was told by the doctor the patient had an autoimmune response to the vaccine that was affected the nerves. This case concerns a 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown after first 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 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown after first 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:

Current Illness:

ID: 1276775
Sex: F
Age: 49
State: CA

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 05/01/2021
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: She could not breathe; she broke out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She could not breathe) in a 49-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 Bronchitis. Concurrent medical conditions included Asthma. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (She could not breathe) (seriousness criterion medically significant) and VACCINATION COMPLICATION (she broke out). On 07-Apr-2021, DYSPNOEA (She could not breathe) had resolved. At the time of the report, VACCINATION COMPLICATION (she broke out) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included unspecified medications used for asthma and bronchitis. Treatment of these events were not reported. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Reporter did not allow further contact; 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: Asthma

ID: 1276776
Sex: F
Age: 33
State: IN

Vax Date: 03/27/2021
Onset Date: 04/25/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Feels uneasy and weak; Pulse is consistently in the 90-100's range; She is out of breath at times with exertion; She is out of breath at times at rest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPNOEA AT REST (She is out of breath at times at rest) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA AT REST (She is out of breath at times at rest) (seriousness criterion medically significant) and DYSPNOEA EXERTIONAL (She is out of breath at times with exertion). On 26-Apr-2021, the patient experienced ASTHENIA (Feels uneasy and weak) and HEART RATE INCREASED (Pulse is consistently in the 90-100's range). At the time of the report, DYSPNOEA AT REST (She is out of breath at times at rest), ASTHENIA (Feels uneasy and weak), HEART RATE INCREASED (Pulse is consistently in the 90-100's range) and DYSPNOEA EXERTIONAL (She is out of breath at times with exertion) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Heart rate: 90-100's /min (High) 90-100's. Concomitant product use was not reported. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; 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: 1276777
Sex: M
Age: 31
State: NY

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 05/01/2021
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: Hearing Loss; Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today; Dizziness; Vertigo; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing Loss) in a 31-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. Concurrent medical conditions included Ringing in ears. On 12-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 (Hearing Loss) (seriousness criterion medically significant), TINNITUS (Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Headache). At the time of the report, DEAFNESS (Hearing Loss), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Headache) outcome was unknown and TINNITUS (Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided. Company Comment: 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. Headache is consistent with the product safety profile; 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. Headache is consistent with the product safety profile

Other Meds:

Current Illness: Ringing in ears

ID: 1276778
Sex: F
Age: 50
State: CA

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Delay 2nd dose 2 weeks, after the 42 days post 1st shot; Had an episode of Afib; Elevated Heart rate 4 hours after first dose; Chest pain; Chest pressure; Palpitation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Had an episode of Afib) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation and Costochondritis on 09-Mar-2021. Concomitant products included METOPROLOL, LOSARTAN, SOTALOL, LEVOTHYROXINE, LIOTHYRONINE and METFORMIN for an unknown indication, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and EMPAGLIFLOZIN (JARDIANCE). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (Elevated Heart rate 4 hours after first dose), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest pressure) and PALPITATIONS (Palpitation). On 07-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Had an episode of Afib) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Delay 2nd dose 2 weeks, after the 42 days post 1st shot). At the time of the report, ATRIAL FIBRILLATION (Had an episode of Afib), HEART RATE INCREASED (Elevated Heart rate 4 hours after first dose), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest pressure) and PALPITATIONS (Palpitation) outcome was unknown and PRODUCT DOSE OMISSION IN ERROR (Delay 2nd dose 2 weeks, after the 42 days post 1st shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Chest X-ray: normal (normal) normal. On 09-Mar-2021, Electrocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Her cardiologist changed her medications from: metoprolol Tartrate 50mg BID, Levothyroxine 200MCG QD, Liothyronine 25mcg 1/2 T Bid, Losartan 100mg QD, Metformin 1000mg BID To: DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Chest X-ray: normal normal. On 09-Mar-2021, Electrocardiogram: normal normal. Losartan 25mg QD, Jardiance 25mg 1/2 T QD, Metoprolol t 50 mg TID, Pradaxa 150mg BID Today(26-Apr-2021) evening she is supposed to stop her Metoprolol Tartrate 50mg TID and start Sotalol 80mg 1/2T BID. Company comment:This case concerns a 50-year-old female with a serious unexpected event of atrial fibrillation, and non-serious unexpected heart rate increased, chest pain, chest discomfort, palpitations, and product dose omission in error. Event onset 19 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.; Sender's Comments: This case concerns a 50-year-old female with a serious unexpected event of atrial fibrillation, and nonserious unexpected heart rate increased, chest pain, chest discomfort, palpitations, and product dose omission in error. Event onset 19 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: PRADAXA; METOPROLOL; JARDIANCE; LOSARTAN; SOTALOL; LEVOTHYROXINE; LIOTHYRONINE; METFORMIN

Current Illness:

ID: 1276779
Sex: F
Age: 52
State: CA

Vax Date: 03/25/2021
Onset Date: 04/23/2021
Rec V Date: 05/01/2021
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: inability to think straight; stomach ache; loss of appetite; weakness; achy feet and hands; feeling like she had the flu; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (inability to think straight) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MENTAL IMPAIRMENT (inability to think straight) (seriousness criterion intervention required), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (muscle ache). On 25-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, MENTAL IMPAIRMENT (inability to think straight), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and MYALGIA (muscle ache) outcome was unknown. Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile. This case was linked to MOD-2021-090510 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile

Other Meds:

Current Illness:

ID: 1276780
Sex: F
Age: 74
State: NY

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 05/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Patient got sick after first shot and was admitted in the hospital; Patient missed second dose and its been more than 42 days already; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient got sick after first shot and was admitted in the hospital) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-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 ILLNESS (Patient got sick after first shot and was admitted in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose and its been more than 42 days already). At the time of the report, ILLNESS (Patient got sick after first shot and was admitted in the hospital) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose and its been more than 42 days already) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No corrective treatment was provided. The patient was on several medications and did not want to go about listing all of them. she wants to know whether she should go ahead and get the second shot or not. She consents to follow up. 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: 1276781
Sex: M
Age:
State:

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 05/01/2021
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: Passed out for a little bit; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for a little bit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for a little bit) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for a little bit) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. Patient passed out for a little bit after his shot. After he came to, he felt thirsty and got some food. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 1276782
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) Unknown. On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) Unknown. Company comment :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. Fever is consistent with the product safety profile; 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. Fever is consistent with the product safety profile

Other Meds:

Current Illness:

ID: 1276783
Sex: F
Age: 64
State: NY

Vax Date: 03/29/2021
Onset Date: 03/31/2021
Rec V Date: 05/01/2021
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: little Sore Arm; Pressure on the Chest; could not breath; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (could not breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (Patient is feeling fatigue and tired due to allergies.). On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DYSPNOEA (could not breath) (seriousness criterion medically significant) and CHEST DISCOMFORT (Pressure on the Chest). On an unknown date, the patient experienced PAIN IN EXTREMITY (little Sore Arm). On 31-Mar-2021, DYSPNOEA (could not breath) and CHEST DISCOMFORT (Pressure on the Chest) had resolved. At the time of the report, PAIN IN EXTREMITY (little Sore Arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy NOS (Patient is feeling fatigue and tired due to allergies.)

ID: 1276784
Sex: F
Age:
State: NY

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 05/01/2021
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: Possible Covid Spots; just wants to sleep all the time; "getting very tired"/more progressively tired"/"not wanting to do anything."; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Possible Covid Spots) and FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced SOMNOLENCE (just wants to sleep all the time). On an unknown date, the patient experienced COVID-19 (Possible Covid Spots) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Possible Covid Spots), FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") and SOMNOLENCE (just wants to sleep all the time) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was hospitalized and prescribed antibiotics. Multiple test were done including head CT and chest x-rays done that showed "possible COVID spots." Patient was discharged to hospice.; Sender's Comments: Although a temporal association exist, based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the fatal event of Covid-19 and the product use is assessed as unlikely. Fatigue and somnolence are also assess as symptoms of Covid-19. However, based on temporality, causality with the product use cannot be excluded.

Other Meds:

Current Illness:

ID: 1276785
Sex: F
Age: 72
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest; was in extreme acidosis; somewhere along the line, I got sepsis; CT scan showed a hematoma in stomach; distended stomach; Still have terrible diarrhea; haven't gotten my second shot yet; following day, I started with extreme chills; Fever; was just miserable for several days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest), ACIDOSIS (was in extreme acidosis), SEPSIS (somewhere along the line, I got sepsis), HAEMATOMA (CT scan showed a hematoma in stomach), GASTRIC DILATATION (distended stomach) and DIARRHOEA (Still have terrible diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), ESTROGENS CONJUGATED (PREMARIN), VITAMIN D3, PROBIOTICS NOS and ALPRAZOLAM (XANAX) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (Still have terrible diarrhea) (seriousness criterion hospitalization prolonged), FEELING ABNORMAL (was just miserable for several days), CHILLS (following day, I started with extreme chills) and PYREXIA (Fever). On 24-Mar-2021, the patient experienced CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest) (seriousness criteria hospitalization prolonged, medically significant and life threatening), ACIDOSIS (was in extreme acidosis) (seriousness criteria hospitalization prolonged and life threatening), SEPSIS (somewhere along the line, I got sepsis) (seriousness criteria hospitalization prolonged and life threatening), HAEMATOMA (CT scan showed a hematoma in stomach) (seriousness criteria hospitalization prolonged and life threatening) and GASTRIC DILATATION (distended stomach) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (haven't gotten my second shot yet). The patient was hospitalized on 24-Mar-2021 due to ACIDOSIS, CARDIAC ARREST, DIARRHOEA, GASTRIC DILATATION, HAEMATOMA and SEPSIS. At the time of the report, CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest), ACIDOSIS (was in extreme acidosis), SEPSIS (somewhere along the line, I got sepsis), HAEMATOMA (CT scan showed a hematoma in stomach), GASTRIC DILATATION (distended stomach), DIARRHOEA (Still have terrible diarrhea), FEELING ABNORMAL (was just miserable for several days), PRODUCT DOSE OMISSION ISSUE (haven't gotten my second shot yet), CHILLS (following day, I started with extreme chills) and PYREXIA (Fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Computerised tomogram: hematoma in stomach (abnormal) Four CT scans. Showed hematoma in stomach. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 24th March 21, Patient had multiple x-rays done. The result was not provided. Treatment for the events was not provided. CPR for 10 minutes which lead to have 4 broken ribs and one lung collapsed.; Sender's Comments: This case of 72 y/o who missed 2nd dose and experienced additional events. Based on the information provided, the events of sepsis, broken ribs and collapse lungs are assessed as unlikely as they occurred was secondary to the other events and intervention. Sepsis is of an infectious origin. Causality between product use and the remaining events cannot be excluded based on temporal association. Missed dose is not applicable and chills and pyrexia are consistent with product safety profile.

Other Meds: PROTONIX [OMEPRAZOLE]; PREMARIN; VITAMIN D3; PROBIOTICS NOS; XANAX

Current Illness:

ID: 1276786
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/17/2021
Rec V Date: 05/01/2021
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: Unevaluable event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion disability). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1276787
Sex: F
Age: 45
State: WI

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Numbness on either side from my elbow to each knee; Shooting pain down my sternum; Wide variations in my blood pressure; Serious asthma attack; Body tremors; Dizziness, wooziness; Chills; Nausea; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Serious asthma attack) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and DIPHENHYDRAMINE for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TREMOR (Body tremors), DIZZINESS (Dizziness, wooziness), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 14-Apr-2021, the patient experienced ASTHMA (Serious asthma attack) (seriousness criterion medically significant). On 16-Apr-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Wide variations in my blood pressure). On 20-Apr-2021, the patient experienced CHEST PAIN (Shooting pain down my sternum). On 22-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness on either side from my elbow to each knee). On 01-Apr-2021, TREMOR (Body tremors) had resolved. On 16-Apr-2021, ASTHMA (Serious asthma attack) had resolved. On 21-Apr-2021, CHEST PAIN (Shooting pain down my sternum) had resolved. On 22-Apr-2021, HYPOAESTHESIA (Numbness on either side from my elbow to each knee) had resolved. On 25-Apr-2021, DIZZINESS (Dizziness, wooziness), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Wide variations in my blood pressure) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) All kinds of blood work came back fine. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was taken to the ER (emergency Room) on 20-APR-2021. Treatment for the events included antihistamine combination of Zyrtec and Diphenhydramine, Benadryl, and Baby Aspirin 81 mg.; Sender's Comments: This case concerns a 45-year-old female with a serious unexpected event of asthma, and nonserious unexpected blood pressure fluctuation, dizziness, chest pain, tremor, hypoaesthesia, and expected chills, headache, nausea. Event onset the same day as first 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: ASPIRIN (E.C.); ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DIPHENHYDRAMINE

Current Illness:

ID: 1276788
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting reaction) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. 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: 1276789
Sex: M
Age: 83
State: CA

Vax Date: 03/01/2021
Onset Date: 03/30/2021
Rec V Date: 05/01/2021
Hospital: Y

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: He had aspirated; Slept all day; Too weak to eat and was given a feeding tube; Not been able to talk; Not been able to swallow; Felt tired; Felt lethargic; Felt weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPIRATION (He had aspirated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Intubation. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LETHARGY (Felt lethargic), ASTHENIA (Felt weak) and FATIGUE (Felt tired). On 02-Apr-2021, the patient experienced ASPIRATION (He had aspirated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk) and DYSPHAGIA (Not been able to swallow). At the time of the report, ASPIRATION (He had aspirated), LETHARGY (Felt lethargic), ASTHENIA (Felt weak), HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk), DYSPHAGIA (Not been able to swallow) and FATIGUE (Felt tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: unknown unknown. On 01-Apr-2021, Chest X-ray: unknown unknown. On 01-Apr-2021, Magnetic resonance imaging: unknown 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.

Other Meds:

Current Illness:

ID: 1276790
Sex: F
Age:
State: NJ

Vax Date: 02/12/2021
Onset Date: 03/29/2021
Rec V Date: 05/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen; she almost died; urinary tract infection; right leg is very swollen; Kept losing consciousness/Passed out; hard time walking; had to use a walker; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen), LOSS OF CONSCIOUSNESS (Kept losing consciousness/Passed out) and FEELING ABNORMAL (she almost died) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 004m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOFLOXACIN, RIVAROXABAN (XARELTO), LISINOPRIL, HYDROCHLOROTHIAZIDE, OXYCODONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced GAIT DISTURBANCE (hard time walking) and WALKING AID USER (had to use a walker). On 12-Apr-2021, the patient experienced THROMBOSIS (having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen) (seriousness criteria hospitalization prolonged, medically significant, life threatening and intervention required) and LOSS OF CONSCIOUSNESS (Kept losing consciousness/Passed out) (seriousness criterion medically significant). 12-Apr-2021, the patient experienced FEELING ABNORMAL (she almost died) (seriousness criteria hospitalization and medically significant). On 26-Apr-2021, the patient experienced PERIPHERAL SWELLING (right leg is very swollen). On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). The patient was hospitalized from 12-Apr-2021 to 19-Apr-2021 due to FEELING ABNORMAL and THROMBOSIS. On 12-Apr-2021, LOSS OF CONSCIOUSNESS (Kept losing consciousness/Passed out) had resolved. At the time of the report, THROMBOSIS (having a blood clot down whole right leg / up right side into right chest / under right breast / several clots in her lower abdomen) was resolving and FEELING ABNORMAL (she almost died), URINARY TRACT INFECTION (urinary tract infection), GAIT DISTURBANCE (hard time walking), PERIPHERAL SWELLING (right leg is very swollen) and WALKING AID USER (had to use a walker) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: blood clots (abnormal) blood clot. On 12-Apr-2021, Ultrasound scan: blood clots (abnormal) blood clots. Action taken with mRNA-1273 in response to the events was not applicable. Patient stated she was in the ICU24-48 hours then transferred to another area of the hospital where she spent another 5-6days. She is still having to use a walker. Her right leg is very swollen. She has to walk and keep her right leg elevated. 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 has been requested. This case was linked to MOD-2021-090647 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information has been requested.

Other Meds: LEVOFLOXACIN; XARELTO; LISINOPRIL; HYDROCHLOROTHIAZIDE; OXYCODONE; SYNTHROID

Current Illness:

ID: 1276791
Sex: M
Age:
State: FL

Vax Date: 03/01/2021
Onset Date: 03/29/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hard to think, it has been very disturbing because he has to think for work, and it has been very difficult; Continued bad and strange dizziness; vertigo that lasted about 3 weeks and was very disturbing; heart was pounding but heart rate was normal; couldn't sleep; brain fogs; hard to think and remember things; feeling of anxiety; There were times when he feels detached from reality; strange feeling of dizziness and nausea feeling; At some point felt like he was almost going to lose consciousness; felling sick like he had the flu; significant pain in arm; fever; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (hard to think, it has been very disturbing because he has to think for work, and it has been very difficult), DIZZINESS (Continued bad and strange dizziness), VERTIGO (vertigo that lasted about 3 weeks and was very disturbing), PALPITATIONS (heart was pounding but heart rate was normal), INSOMNIA (couldn't sleep), FEELING ABNORMAL (brain fogs), MEMORY IMPAIRMENT (hard to think and remember things), ANXIETY (feeling of anxiety), DISSOCIATION (There were times when he feels detached from reality) and NAUSEA (strange feeling of dizziness and nausea feeling) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy (Respiratory allergies). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felling sick like he had the flu), PAIN IN EXTREMITY (significant pain in arm), PYREXIA (fever) and CHILLS (chills). In April 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENTAL IMPAIRMENT (hard to think, it has been very disturbing because he has to think for work, and it has been very difficult) (seriousness criterion medically significant), DIZZINESS (Continued bad and strange dizziness) (seriousness criterion medically significant), VERTIGO (vertigo that lasted about 3 weeks and was very disturbing) (seriousness criterion medically significant), PALPITATIONS (heart was pounding but heart rate was normal) (seriousness criterion medically significant), INSOMNIA (couldn't sleep) (seriousness criterion medically significant), FEELING ABNORMAL (brain fogs) (seriousness criterion medically significant), MEMORY IMPAIRMENT (hard to think and remember things) (seriousness criterion medically significant), ANXIETY (feeling of anxiety) (seriousness criterion medically significant), DISSOCIATION (There were times when he feels detached from reality) (seriousness criterion medically significant), NAUSEA (strange feeling of dizziness and nausea feeling) (seriousness criterion medically significant) and PRESYNCOPE (At some point felt like he was almost going to lose consciousness). At the time of the report, MENTAL IMPAIRMENT (hard to think, it has been very disturbing because he has to think for work, and it has been very difficult), PALPITATIONS (heart was pounding but heart rate was normal), INSOMNIA (couldn't sleep), FEELING ABNORMAL (brain fogs), MEMORY IMPAIRMENT (hard to think and remember things), ANXIETY (feeling of anxiety), DISSOCIATION (There were times when he feels detached from reality), NAUSEA (strange feeling of dizziness and nausea feeling), PRESYNCOPE (At some point felt like he was almost going to lose consciousness), INFLUENZA LIKE ILLNESS (felling sick like he had the flu), PAIN IN EXTREMITY (significant pain in arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown, DIZZINESS (Continued bad and strange dizziness) had not resolved and VERTIGO (vertigo that lasted about 3 weeks and was very disturbing) had resolved. Patient reports he takes supplements as concomitant medications Patient was prescribed clonazepam for his anxiety and took ibuprofen for his symptoms. Patient went to the ER two weeks after receiving the second dose of the vaccine, he was checked out, ran some tests and everything was within normal limits. Blood work was normal. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company comment: 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. Chills and pyrexia are consistent with the product safety profile. This case was linked to MOD-2021-090675 (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. Chills and pyrexia are consistent with the product safety profile

Other Meds:

Current Illness: Allergy (Respiratory allergies)

ID: 1276792
Sex: F
Age: 58
State: IL

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Underneath my eyebrow is real puffy and the corner is puffy; Eyelids itching; Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye; Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye; it just started to run just a little bit; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0158) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Acid reflux (esophageal) and Anxiety attack. Concurrent medical conditions included Blood pressure high and Acquired hypothyroidism. Concomitant products included CLONAZEPAM for Anxiety attack, METOPROLOL, AMLODIPINE and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication. On 15-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 PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy) (seriousness criterion medically significant), EYELIDS PRURITUS (Eyelids itching), SWELLING OF EYELID (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye), OCULAR DISCOMFORT (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye) and LACRIMATION INCREASED (it just started to run just a little bit). At the time of the report, PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy), EYELIDS PRURITUS (Eyelids itching), SWELLING OF EYELID (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye), OCULAR DISCOMFORT (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye) and LACRIMATION INCREASED (it just started to run just a little bit) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient received treatment with Biotrue eye drops.

Other Meds: METOPROLOL; AMLODIPINE; CLONAZEPAM; PRILOSEC [OMEPRAZOLE MAGNESIUM]

Current Illness: Acquired hypothyroidism; Blood pressure high

ID: 1276793
Sex: F
Age: 60
State: WA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 05/01/2021
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: all the tumor masses in her body were painful; all the tumor masses in her body were painful and uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of TUMOUR PAIN (all the tumor masses in her body were painful) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Neurofibromatosis (Elephant man disease.). Concomitant products included MORPHINE for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUMOUR PAIN (all the tumor masses in her body were painful) (seriousness criterion medically significant) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) (seriousness criterion medically significant). At the time of the report, TUMOUR PAIN (all the tumor masses in her body were painful) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) outcome was unknown. Not Provided Treatment of these events included the patient's concomitant use of morphine. 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

Other Meds: MORPHINE

Current Illness: Neurofibromatosis (Elephant man disease.)

ID: 1276794
Sex: F
Age: 67
State: OH

Vax Date: 02/26/2021
Onset Date: 04/02/2021
Rec V Date: 05/01/2021
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: Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Apr-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to THROMBOSIS. The patient was treated with Surgery (Angioplasty) for Thrombosis. On 06-Apr-2021, THROMBOSIS (Blood clot in leg) had resolved. Not Provided Concomitant product use was not provided by the reporter. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on current available information and the temporal association between product use and the stat date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1276795
Sex: M
Age: 56
State: NY

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 05/01/2021
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: multiple heart arrhythmias; increased sense of pressure in his chest; shortness of breath; light headed feeling; weakness; welt that was red, sore, and very hot; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (multiple heart arrhythmias) in a 57-year-old male 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. Concurrent medical conditions included Hypertrophic cardiomyopathy (experiencing flare ups which he says he has had before). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (multiple heart arrhythmias) (seriousness criterion medically significant), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness). At the time of the report, ARRHYTHMIA (multiple heart arrhythmias), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness: Hypertrophic cardiomyopathy (experiencing flare ups which he says he has had before)

Date Died:

ID: 1276796
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot) (seriousness criterion death). The reported cause of death was Clot blood. It is unknown if an autopsy was performed. The reporter stated that his wife had recently passed away from a blood clot after receiving a second dose of the Moderna COVID-19 vaccine. Treatment information was not provided. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Clot blood

Other Meds:

Current Illness:

ID: 1276797
Sex: M
Age: 90
State: CA

Vax Date: 02/17/2021
Onset Date: 03/15/2021
Rec V Date: 05/01/2021
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: began treatment to remove water from my system; suspected lung damage/something happened in my lungs; sleep difficult; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LUNG DISORDER (suspected lung damage/something happened in my lungs) and FLUID RETENTION (began treatment to remove water from my system) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Smoker (hasn't smoked in 40 years) and Alcohol use (has not had in 30 years). Concurrent medical conditions included Hypertension since 03-Apr-1966. Concomitant products included METOPROLOL SUCCINATE (TOPROL) from 03-Apr-1966 to an unknown date and TRIAMINICIN [ACETYLSALICYLIC ACID;ALUMINIUM HYDROXIDE GEL, DRIED;CAFFEINE;MEPYRAMINE MALEATE;PARACETAMOL;PHENIRAMINE MALEATE;PHENYLPROPANOLAMINE HYDROCHLORIDE] from 03-Apr-1966 to an unknown date for Hypertension, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 17-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced LUNG DISORDER (suspected lung damage/something happened in my lungs) (seriousness criterion hospitalization). On an unknown date, the patient experienced FLUID RETENTION (began treatment to remove water from my system) (seriousness criterion hospitalization) and INSOMNIA (sleep difficult). The patient was hospitalized from 18-Mar-2021 to 31-Mar-2021 due to FLUID RETENTION and LUNG DISORDER. At the time of the report, LUNG DISORDER (suspected lung damage/something happened in my lungs) had not resolved and FLUID RETENTION (began treatment to remove water from my system) and INSOMNIA (sleep difficult) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Laboratory test: normal no sign of a heart attack. In March 2021, X-ray: abnormal (abnormal) confirmed something was happening in lungs. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LUNG DISORDER (suspected lung damage/something happened in my lungs), FLUID RETENTION (began treatment to remove water from my system) and INSOMNIA (sleep difficult) to be probably related. The reporter is a physician and also the patient. He stated that on the ight of the second vaccination, "being aware of the previous problem, I was conscious of similar things happening to my body." On 16 Mar 2021 (reported as in the morning; also reported onset of event to be 17 Mar 2021), he went to his family doctor and was told to go to the emergency room (ER). Instead, the patient went to a cardiologist, who ran tests and saw no sign of a heart attack. The cardiologist suspected lung damage and sent the patient to urgent care, where x-rays confirmed "something happening in my lungs." He was then admitted to the ER and later "began treatment to remove water from my system." Cancer was ruled out. The patient felt the events were most likely caused by mRNA-1273 and answered "no" when asked if there were other potential causes. This case was linked to MOD-2021-016921 (Patient Link).

Other Meds: TOPROL; PRILOSEC [OMEPRAZOLE]

Current Illness: Hypertension

ID: 1276798
Sex: M
Age: 63
State: OK

Vax Date: 04/08/2021
Onset Date: 04/10/2021
Rec V Date: 05/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Rash developed on arm opposite of injection site, spread across entire body; Swelling under his arm; lymphadenopathy; Mildly feverish; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash developed on arm opposite of injection site, spread across entire body) and LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-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 LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced RASH (Rash developed on arm opposite of injection site, spread across entire body) (seriousness criterion hospitalization) and PYREXIA (Mildly feverish). At the time of the report, RASH (Rash developed on arm opposite of injection site, spread across entire body), LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) and PYREXIA (Mildly feverish) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication include unknown Inhalers, Blood pressure meds, cholesterol and cough medicine Patient was treated with IV steroids for an unrelated condition; however, physician believes patient might see some benefit. 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: 1276799
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: Husband did have arm soreness after getting the Covid vaccine; This is a spontaneous report received from a contactable consumer (patient's wife). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an covid-19 immunisation. Medical history included cardiac disorder, diabetes mellitus from 1995, open heart surgery in 2018 and allergy to tilcid. Clarified he had cardiac & diabetic issues prior to the 1st dose of vaccine. The due date of second vaccine was on 10Feb2021.The patient was on multiple medications for his heart and for his diabetes. On unspecified date, the patient experienced arm soreness after getting the Covid vaccine, but otherwise was fine. The outcome of event was unknown. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness: Open heart surgery (He had open heart surgery in 2018)

ID: 1276800
Sex: F
Age:
State: GA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 05/01/2021
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: my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); stomach upset; fatigue; Little bit of chills; sluggishness; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient (non pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via intramuscularly administered in left arm on 31Dec2020 10:00 AM and dose 2 via intramuscularly administered in left arm on 21Jan2021 12:00 PM (at 26-years-old and non pregnant at the time of vaccination )(Batch/Lot Number: EL3247) both as single dose for covid-19 immunization. Medical history included anxiety, asthma, allergies, irritable bowel syndrome from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included Sertraline HCL 100mg, Junel (birth control), Trazodone within two weeks. prior to vaccination. No other vaccine taken within four weeks prior to vaccination. Patient had no Covid prior to vaccination and not tested for Covid post vaccination. On 21Jan2021 at 05:30 PM, after second dose patient experienced sore arm slowly and became more and more. She had a hard time sleeping and woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in her entire body). Also had stomach upset and fatigue/sluggishness. Little bit of chills. All of the symptoms continued throughout the rest of the day. Therapeutic measures taken which included Tylenol at 4am, 10am, and 4pm for it. Outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: SERTRALINE HCL; JUNEL; TRAZODONE

Current Illness:

ID: 1276801
Sex: F
Age:
State: MA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 05/01/2021
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: Tingling and numbness in the arm where injection occurred; Tingling and numbness in the arm where injection occurred; This is a spontaneous report from a contactable consumer reported for a female patient. A female patient of unspecified age (unknown if pregnant at the time of vaccination) received her first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021, the patient had tingling and numbness in the arm where injection occurred. It was unknown if the patient received any other vaccines within four weeks prior to the Covid vaccine. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination nor has the patient been tested for Covid-19 since the vaccination. Outcome was unknown for the events. Information on the lot/batch number has been requested. Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1276802
Sex: M
Age: 34
State: CA

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Muscle soreness onset in 6 h, lasting for 2 days, self-limiting unilateral left axillary lymphadenopathy onset on day 4, lasting for 3 days, self-limiting.

Other Meds:

Current Illness:

ID: 1276803
Sex: F
Age: 24
State: FL

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 05/01/2021
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: Penicillin, lactose intolerant.

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Second dose seemed to be placed higher than the first. Pain started roughly four hours later and I could not move my arm for 5 days at all without being in excruciating pain. I started stretching arm out and most of pain went away but I still cannot go to work and function normally without being in major pain, 9 days later.

Other Meds: Ibuprofen, Melatonin.

Current Illness: NA

ID: 1276804
Sex: F
Age: 49
State: NC

Vax Date: 04/08/2021
Onset Date: 04/27/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies: Penicillin Gluten and wheat

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

Symptoms: Very vivid and bizarre dreams every night starting 4 nights ago. Also, deeper sleep but I wake up well rested.

Other Meds: Lisinopril 10mg daily Daily probiotic

Current Illness: N/a

ID: 1276805
Sex: F
Age: 63
State: MI

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 05/01/2021
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: Gluten free, adherence to "Leaky Gut" Diet

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

Symptoms: 04-22-2021 I had first dose of vaccine. At that time, within 2 hours, I was numb, like Novocaine numb, on my left side from were I got the injection up to my forehead. The left side of my face, tongue, right down the middle of my mouth and neck. It took two days for that to fayed away and feeling to return. Swelling started 24 hours after injection, the following morning, my tongue and soft tissue in mouth, face, neck, hands, wrists, ankles. In fact I'm 8-10 pound's heavier than before injection with fluid retention. Benadryl tabs are having no effect to relieve my discomfort. Bladder and kidneys function seem normal, bowel and digestion as well. Difficulty swallowing and mild upper sore throat. Random heat waves up chest to top of head. No fever registering at any time. Developed "burning" irritation in underarm, red patches in left armpit, 3-4 days after injection. Treating that with Neosporin ointment, as yet not healed.

Other Meds: None

Current Illness:

ID: 1276806
Sex: F
Age: 30
State: CA

Vax Date: 04/23/2021
Onset Date: 04/30/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies: Unknown

Symptom List: Pain in extremity

Symptoms: Injection is red and hard to touch. Upper arm/shoulder is hard to touch as well. ?Vaccine arm? without rash.

Other Meds: N/a

Current Illness: None

ID: 1276807
Sex: F
Age: 29
State: NJ

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

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

Lab Data:

Allergies: None

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

Symptoms: Heavy bleeding and extremely painful menstrual cramps during next menstrual cycle following second dose.

Other Meds: None

Current Illness: None

ID: 1276808
Sex: M
Age: 72
State: HI

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 05/01/2021
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: None

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Flu like symptom 24 hours after second shot then, not steady balance. Now, constant hissing sound.

Other Meds: multi vitamins

Current Illness:

ID: 1276809
Sex: F
Age: 37
State: CA

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 05/01/2021
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: no

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

Symptoms: For the first couple of days, I've been experienced some side effects, like pain in the arm I got shot, tiredness, headache, fatigue, rapid heart rate, muscle pain and nausea. Some of them were completely gone afterwards, but rapid heart rate, pain in the chest (both of them last for quite a while and don't seem to appear after any physical activity but at rest), shortness of breath even at rest, fatigue, sometimes nausea (that come and go pretty fast without any reason) are still with me after a week after the first shot. I don't feel like I'm able to do any workout also. I also have a slight cough too.

Other Meds: no

Current Illness: no

ID: 1276810
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 05/01/2021
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: slight fever; Upon Follow up the case considered as valid as slight fever (event) reported. This is a spontaneous report from a contactable Consumer (patient). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) dose 1and dose 2 via unspecified route of administration on unspecified date in Feb2021 and Mar2021 respectively, both at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient experienced Slight fever on unspecified date. The outcome of the events was unknown. Follow up (03Apr2021): Upon review of the Non-Serious Cases Line Listing report dated [03Apr2021], the following corrections have been made: [recode the event ?potentially exposed to COVID to no adverse effect and kindly delete the event ?scheduled to receive the first dose of the vaccine tomorrow'. Please make the case as invalid: this is a medical inquiry only and the patient had not received the vaccine yet]. Follow up (03Apr2021): New information received from Pfizer-sponsored program. A contactable consumer reported that includes: new event and month of vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276811
Sex: F
Age:
State: GA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn't' stand up; Her arm was so sore/arm hurt a bit; Bone in body hurt and everyplace she has arthritis was worse; Bone in body hurt and everyplace she has arthritis was worse; Carpal tunnel reacted adversely; A prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via unspecified route of administration at arm left on 02Feb2021 08:00 AM at single dose for COVID-19 immunization. The patient's medical history included arthritis and she has had surgeries. Concomitant medication was not reported. The patient received her 1st dose of the Pfizer Covid vaccine on 02Feb2021 and said she was fine up until the night of the same day wherein she woke up from her sound sleep feeling absolutely in pain. Mentioned that the parts of her body where she had arthritis and her carpal tunnel acted up which she has never experienced before and said that she normally did not have problems like this. She also cannot get out of bed and said that her husband had to her help her out and she also had a rash. Currently, she was still experiencing tenderness on the injection site and some aches and pains on her body but not as bad as it previously was. The patient had bone in body hurt and everyplace she has arthritis was worse. The patient had the injection on 02Feb2021 at 8AM, and did ok with it, her arm hurt a bit, not bad, and that night she went to bed, and it was every bone in her body hurt and everyplace she has arthritis was worse, and her carpal tunnel reacted adversely, her arm was so sore, she can't believe it, now she has developed a rash. Her arm hurt that night, is a little tender now, it was not real red, just tender. Her husband had to help her out of bed, she could not stand up, she was not a baby, she has had surgeries, she responds well to that kind of thing, so this was unusual. Yesterday she was in bed all day, she did not get out of bed until 5PM. This all came on all of a sudden, she woke out of a sound sleep, she was totally terribly miserable. States her rash through lasted through yesterday, now she has developed a rash, a prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting, but she is sure it will fade, she has had reactions to things before. No further details provided. She has not had any other tests or anything lately. No injections, none of that. Would like to know if she has to get her 2nd dose or not. The outcome of the events her arm was so sore/arm hurt a bit, bone in body hurt and everyplace she has arthritis was worse, Carpal tunnel reacted adversely was recovering/resolving. The outcome of the events rash, pain and cannot get out of bed/she could not stand up was unknown. The outcome of the events tenderness on the injection site was not recovered/not resolved.

Other Meds:

Current Illness:

ID: 1276812
Sex: F
Age:
State: CA

Vax Date: 12/23/2020
Onset Date: 01/05/2021
Rec V Date: 05/01/2021
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: Right ear infection; headaches with jaw pain; headaches with jaw pain; This is a spontaneous report from a contactable other health care professional. A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via intramuscular, administered in left arm on 23Dec2020 17:30 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunisation. Medical history included Polycystic ovary, asthma and eczema and known allergies to a yellow mushroom from overwatering house plants. Concomitant medication included triamcinolone acetonide ( 0.1% cream) topical. Other medications in two weeks: topical triamcinolone acetonide 0.1% cream; On 05Jan2021 12:00, Patient had right ear infection with right sided headaches 2 weeks after the first dose. Worsened sharp headaches with jaw pain. Headaches became mild and jaw pain relieved when I removed ear wax. The patient received treatment includes ear wax removal and "neomycin and polymyxin b sulfates and hydrocortisone 1% otic suspension. Patient not had covid prior vaccination; not tested covid post vaccination. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: TRIAMCINOLONE ACETONIDE

Current Illness:

ID: 1276813
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: Little soreness; This is a follow-up spontaneous report from a Pfizer-sponsored program. A 78-year-old contactable male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced little soreness on the site where it has been injected. Patient took treatment as opioid (pain medication). Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276814
Sex: F
Age:
State: NJ

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 05/01/2021
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: Headache started after 26hr of vaccination and a low grade fever started with chills after 30hrsof 2nd dose.; chills followed by low grade fever; chills followed by low grade fever; This is a spontaneous report from a contactable consumer (reported on herself). This 49-year-old female patient received second dose of BNT162B2 (COVID vaccine, solution for injection, lot number EL3247 expiry date: unknown) via an unspecified route of administration on in Left arm as a single dose on 09Feb2021 09:45 AM, for Covid-19 immunization. Medical history included asthma. She was allergic to Aspirin. Concomitant medications (within two weeks of vac-cine) included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (Advair), MONTELUKAST SODIUM (Singulair) and ESOMEPRAZOLE SODIUM (Nexium). She received first dose of BNT162B2 (COVID vaccine, solution for injection, lot number EL3247expiry date: unknown) via an unspecified route of administration on in Left arm as a single dose on 19Jan2021 10:00 AM, for Covid-19 immunization. She did not receive any other vaccine in four weeks of Covid-19 vaccine. On 10Feb2021 around 12: 45pm, in the afternoon, she experienced headache, but she did not think that this was related to vaccine and she continued with her routine on remaining of the day. After 6pm on 10Feb2021, she experienced chills followed by low grade fever. The patient did not receive any treatment for the events. The outcome of the events of headache and chills followed by low grade fever was recovering. The patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination. No further information was available.

Other Meds: ADVAIR; SINGULAIR; NEXIUM [ESOMEPRAZOLE SODIUM]

Current Illness:

ID: 1276815
Sex: F
Age:
State: NJ

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain; earache; goopy eye; headache; exhaustion; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 13:30 (at the time of 56-years-old) as single dose for covid-19 immunisation. Medical history included Von Willebrand's and history of lyme disease, allergies: Peanut and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamin supplements within 2 weeks of vaccination. Concomitant medication included vitamin supplements. After first shot in left arm, only on my left side I had: muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered on Jan2021. The patient received treatment as epipen on hand. Therapeutic measures were taken as a result of events. The outcome of events was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm