VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1435924
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 06/30/2021
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: Blackout; Muscle twitching; Tingling; Cramps legs; Facial spasm; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011321A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia). At the time of the report, LOSS OF CONSCIOUSNESS (Blackout), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia) outcome was unknown. Concomitant product use was not provided. At the time of the report, the patient is awaiting results of a magnetic resonance imaging test. Treatment information was not provided. This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died:

ID: 1435925
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: Fatal fevers; Septic shock; Product contamination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fatal fevers), SEPTIC SHOCK (Septic shock) and PRODUCT CONTAMINATION (Product contamination) in an elderly patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fatal fevers) (seriousness criterion death), SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION (Product contamination) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided. 104 Patients received the vaccine. 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.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1435926
Sex: F
Age: 78
State: IL

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data: Test Date: 20210310; Test Name: ECG; Result Unstructured Data: Confirmed Atrial fibrillation; Test Date: 202102; Test Name: Brain MRI; Result Unstructured Data: Confirmed brain is bleeding; Test Date: 20210608; Test Name: Foot x-ray; Result Unstructured Data: Confirmed broken foot

Allergies:

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

Symptoms: broken foot; Fall; Unevaluable event; Atrial fibrillation; Fall; Cerebral bleeding; Stroke; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), the first episode of FALL (Fall), FOOT FRACTURE (broken foot), the second episode of FALL (Fall) and UNEVALUABLE EVENT (Unevaluable event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Depression, Bladder disorder, Cholesterol, Abstains from alcohol and Non-smoker. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (DITROPAN) for Bladder disorder, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METOPROLOL for Heart disorder, MIRTAZAPINE (REMERON) for Unevaluable reaction. In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of FALL (Fall) (seriousness criteria hospitalization and disability). In February 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant) and UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). On 08-Jun-2021, the patient experienced FOOT FRACTURE (broken foot) (seriousness criteria hospitalization and disability) and the second episode of FALL (Fall) (seriousness criteria hospitalization and disability). The patient was hospitalized from 15-Feb-2021 to 18-Feb-2021 due to ATRIAL FIBRILLATION, CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT and FALL. On 08-Jun-2021, last episode of FALL (Fall) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), FOOT FRACTURE (broken foot) and UNEVALUABLE EVENT (Unevaluable event) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging head: confirmed brain is bleeding (abnormal) Confirmed brain is bleeding. On 10-Mar-2021, Electrocardiogram: confirmed atrial fibrillation (abnormal) Confirmed Atrial fibrillation. On 08-Jun-2021, X-ray limb: confirmed broken foot (abnormal) Confirmed broken foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was sent to urgent care because the patient fell again and it was determined that her left foot was broken where a boot cast was put on her left leg and was advised to have bed rest and had the left leg elevated. The patient was waiting for brain bleeding to heal. 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: METOPROLOL; REMERON; DITROPAN; WELLBUTRIN; ATORVASTATIN

Current Illness: Abstains from alcohol; Bladder disorder; Cholesterol; Depression; Non-smoker

ID: 1435927
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: Plenty of blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Plenty of blood clots) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Plenty of blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Plenty of blood clots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. No Treatment information was 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

Other Meds:

Current Illness:

ID: 1435928
Sex: M
Age:
State: NC

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hearing loss/deafness; Fluid in middle ear; Ear infection; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (hearing loss/deafness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DEAFNESS (hearing loss/deafness) (seriousness criterion medically significant), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection). The patient was treated with PREDNISONE at a dose of 40 mg once a day. At the time of the report, DEAFNESS (hearing loss/deafness), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patient had 60% hearing loss/deafness due to fluid buildup and infection in ears that developed shortly after his first Moderna vaccine after 14-Apr-2021. Patient developed same symptoms shortly after second vaccine on 15-May-1021. Both times the patient was treated with a 5-day course of Prednisone 40 mg PO QD, and events resolved. Action taken with mRNA-1273 in response to the event was not applicable. 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: ELIGARD

Current Illness:

ID: 1435929
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: stroke; always tired; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received 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 CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and FATIGUE (always tired). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) and FATIGUE (always tired) outcome was unknown. Concomitant product use was not provided by the reporter. The patient had stroke 3 months after taking the 2nd shot. Treatment information was not provided. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435930
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Seven weeks after receiving second moderna vaccine, my wife developed a rapidly growing lymphoma on neck) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. 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: 1435931
Sex: M
Age: 33
State: FL

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Blood in stool; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 17-Jun-2021, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant). On 15-Jun-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in stool) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient experienced pain at the injection site the day he received the vaccine and stopped the following day (15 Jun 2021). Patient also noticed blood in his stools on 17 Jun 2021. Consumer did not take any medications to treat his symptoms and is not taking any concurrent medications. No further treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1435932
Sex: M
Age: 74
State: CA

Vax Date: 02/13/2021
Onset Date: 04/01/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 PCR test negative; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Minor heart attack; blood clots in his lung, leg and heart; blood clots in his lung, leg and heart; blood clots in his lung, leg and heart; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Minor heart attack), PULMONARY THROMBOSIS (blood clots in his lung, leg and heart), THROMBOSIS (blood clots in his lung, leg and heart) and INTRACARDIAC THROMBUS (blood clots in his lung, leg and heart) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYOCARDIAL INFARCTION (Minor heart attack) (seriousness criteria hospitalization and medically significant), PULMONARY THROMBOSIS (blood clots in his lung, leg and heart) (seriousness criteria medically significant and life threatening), THROMBOSIS (blood clots in his lung, leg and heart) (seriousness criteria medically significant and life threatening) and INTRACARDIAC THROMBUS (blood clots in his lung, leg and heart) (seriousness criteria medically significant and life threatening). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to MYOCARDIAL INFARCTION. The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 mg; CLOPIDOGREL BISULFATE at a dose of 75 mg and AMIODARONE at a dose of 100 mg. In April 2021, MYOCARDIAL INFARCTION (Minor heart attack) had resolved. At the time of the report, PULMONARY THROMBOSIS (blood clots in his lung, leg and heart), THROMBOSIS (blood clots in his lung, leg and heart) and INTRACARDIAC THROMBUS (blood clots in his lung, leg and heart) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The patient presented to the hospital and was admitted to the Intensive Care Unit (ICU) for a 7 day hospital admission sometime in April 2021 where he was diagnosed and treated for the reported events. Follow-up blood tests and a sonogram of the patient's leg was performed the week of 06-Jun-2021 through 12-Jun-2021 and a heart sonogram was scheduled on 16-Jun-2021. He was to speak with the doctor about the results on 18-Jun-2021. This case concerns a 74-year-old male hospitalized with serious unexpected events of myocardial infarction, pulmonary thrombosis, thrombosis, and intracardiac thrombus. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 74-year-old male hospitalized with serious unexpected events of myocardial infarction, pulmonary thrombosis, thrombosis, and intracardiac thrombus. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1435933
Sex: F
Age:
State: VA

Vax Date: 04/01/2021
Onset Date: 04/22/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data: Test Date: 202104; Test Name: Hearing test; Test Result: Positive ; Result Unstructured Data: Profound hearing loss

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Zero to no hearing in her left ear; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Zero to no hearing in her left ear) in a 23-year-old female patient 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. The patient's past medical history included Hearing disability (Hearing issues, but not to the point of deafness/lost of hearing.) and Ear tube insertion. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Zero to no hearing in her left ear) (seriousness criterion medically significant) and VERTIGO (Vertigo). The patient was treated with PREDNISONE ongoing since an unknown date for Hearing loss, at an unspecified dose and frequency. At the time of the report, DEAFNESS UNILATERAL (Zero to no hearing in her left ear) and VERTIGO (Vertigo) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Acoustic stimulation tests: profound hearing loss (Positive) Profound hearing loss. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product used was provided by the reporter. Around 22-Apr-2021, the patient started experiencing vertigo and went to the doctor. A hearing test was performed because she had zero to no hearing in her left ear. Hearing test indicated profound hearing loss. The doctor thinks the vaccine caused her hearing loss. They told her to get a COVID and antibody test because the virus might have caused the hearing loss. The patient had therapy for her ears and she regained her hearing back a little bit, but she will still have to get hearing aids. Treatment information included prednisone and hearing aids. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-Jun-2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

Date Died: 01/21/2021

ID: 1435934
Sex: F
Age: 83
State: IN

Vax Date: 01/08/2021
Onset Date: 01/16/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: She had a non traumatic intracerebral hemorrhage; Never regained consciousness after the stroke/unresponsiveness; Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) and CEREBROVASCULAR ACCIDENT (Stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Type 2 diabetes mellitus on 21-Jan-2021. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) (seriousness criteria death, hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 21-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medications include unspecified medications for diabetes and low pressure. Reporter further explained the event as non traumatic intracerebral hemorrhage. Patient was hospitalized for some days and died one or two days after coming back to home. The treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1435935
Sex: F
Age: 25
State: CA

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 06/30/2021
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: Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. In about a period of two weeks, the ultrasound indicated that the baby's heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage. Date of last menstrual period and estimated due date were not provided. No treatment was given. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-226308 (Parent-Child Link). See case MOD-2021-226308 for details regarding the child case.; 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: 1435936
Sex: U
Age:
State: MO

Vax Date: 03/08/2021
Onset Date: 03/22/2021
Rec V Date: 06/30/2021
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: Nerve pain down the arm; Lymph node swelled up like hard mass. Its still their I can feel it.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain down the arm) and LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 028A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) (seriousness criterion medically significant). On 23-Mar-2021, the patient experienced NEURALGIA (Nerve pain down the arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Nerve pain, at a dose of 1 dosage form. On 17-Jun-2021, NEURALGIA (Nerve pain down the arm) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swelled up like hard mass. Its still their I can feel it.) outcome was unknown. Laboratory data included Ultrasound Biopsy. No Concomitant medication details was provided. No treatment medication details was provided. Patient will be getting surgery scheduled in July to remove his lymph nodes (supraclavicular lymph node removal left side of the collar bone). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-226030 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435937
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: lost her eye sight for around 5 mins; Impaired vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Impaired vision). At the time of the report, BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) had resolved and VISUAL IMPAIRMENT (Impaired vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication were not provided. Treatment information was not provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Very limited information regarding the date of vaccine administration and the start dates of the events have been provided. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Additional information received patient demographics, dose details and event updated.; Sender's Comments: Very limited information regarding the date of vaccine administration and the start dates of the events have been provided. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435938
Sex: U
Age:
State:

Vax Date: 06/15/2021
Onset Date:
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Can't hear with my left ear; Lost my tastebuds; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Can't hear with my left ear) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Can't hear with my left ear) (seriousness criterion medically significant) and AGEUSIA (Lost my tastebuds). At the time of the report, DEAFNESS (Can't hear with my left ear) and AGEUSIA (Lost my tastebuds) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. further information has been requested.

Other Meds:

Current Illness:

ID: 1435939
Sex: M
Age:
State: IA

Vax Date: 02/28/2021
Onset Date: 03/23/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data: Test Date: 20210615; Test Name: BLOOD GLUCOSE; Result Unstructured Data: normal; Test Date: 20210329; Test Name: fever; Result Unstructured Data: Fever 103 Fahrenheit; Test Date: 20210315; Test Name: SARS-COV-2; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Confusion; FREEZING; Fever 101 F; Chills; Extreme Fatigue; Confusion after Second Shot; Sleepy after Second Shot; Less Severe Reaction after Second Shot; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), FEELING COLD (FREEZING), PYREXIA (Fever 101 F), CHILLS (Chills) and FATIGUE (Extreme Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. # 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Blood pressure high, Cholesterosis and Seizure. Concomitant products included SIMVASTATIN for Cholesterosis, METOPROLOL TARTRATE for Hypertension, VALPROATE SEMISODIUM (DEPAKOTE) for Seizures, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (Fever). On 29-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion after Second Shot), SOMNOLENCE (Sleepy after Second Shot) and VACCINATION COMPLICATION (Less Severe Reaction after Second Shot). On 14-Jun-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), FEELING COLD (FREEZING) (seriousness criterion hospitalization), PYREXIA (Fever 101 F) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and FATIGUE (Extreme Fatigue) (seriousness criterion hospitalization). The patient was hospitalized from 15-Jun-2021 to 17-Jun-2021 due to CHILLS, CONFUSIONAL STATE, FATIGUE, FEELING COLD and PYREXIA. On 31-Mar-2021, CONFUSIONAL STATE (Confusion after Second Shot), SOMNOLENCE (Sleepy after Second Shot) and VACCINATION COMPLICATION (Less Severe Reaction after Second Shot) had resolved. At the time of the report, CONFUSIONAL STATE (Confusion), FEELING COLD (FREEZING), PYREXIA (Fever 101 F), CHILLS (Chills) and FATIGUE (Extreme Fatigue) had not resolved and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 29-Mar-2021, Pyrexia: 103 f Fever 103 Fahrenheit. On 15-Jun-2021, Blood glucose: normal normal. No treatment medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-226361 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METOPROLOL TARTRATE; SIMVASTATIN; DEPAKOTE; IBUPROFEN; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Blood pressure high; Cholesterosis; Seizure

ID: 1435940
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: Blood potassium; Result Unstructured Data: Decreased; Test Date: 2021; Test Name: Blood sodium; Result Unstructured Data: Decreased

Allergies:

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

Symptoms: Brain infection viral meningitis; Psychosis; Dehydration; Almost in coma; Caused his body to go haywire; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Meningitis (Spinal meningitis) and Infection (Had an infection before 1st dose and took medicine.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENINGITIS VIRAL (Brain infection viral meningitis) (seriousness criteria hospitalization and medically significant), PSYCHOTIC DISORDER (Psychosis) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), COMA (Almost in coma) (seriousness criteria hospitalization and medically significant) and FEELING ABNORMAL (Caused his body to go haywire) (seriousness criterion hospitalization). At the time of the report, MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood potassium: low (Low) Decreased. In 2021, Blood sodium: low (Low) Decreased. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-226811, MOD-2021-072608 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1435942
Sex: M
Age: 49
State: MD

Vax Date: 03/26/2021
Onset Date: 04/23/2021
Rec V Date: 06/30/2021
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: Excruciating pain; all joints became extremely sore; it is getting worse and worse; he believes this was caused by the vaccine; can't move and is using crutches; thinks there is autoimmune reaction happening; feels trauma in ligaments; can't move; This spontaneous case was reported by a consumer and describes the occurrence of WALKING AID USER (can't move and is using crutches) and AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-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 WALKING AID USER (can't move and is using crutches) (seriousness criterion disability), AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening) (seriousness criterion medically significant), LIGAMENT PAIN (feels trauma in ligaments) and GAIT INABILITY (can't move). On 18-Jun-2021, the patient experienced CONDITION AGGRAVATED (it is getting worse and worse) and VACCINATION COMPLICATION (he believes this was caused by the vaccine). On an unknown date, the patient experienced PAIN (Excruciating pain) and ARTHRALGIA (all joints became extremely sore). At the time of the report, WALKING AID USER (can't move and is using crutches), AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening), LIGAMENT PAIN (feels trauma in ligaments), GAIT INABILITY (can't move), CONDITION AGGRAVATED (it is getting worse and worse), VACCINATION COMPLICATION (he believes this was caused by the vaccine), PAIN (Excruciating pain) and ARTHRALGIA (all joints became extremely sore) outcome was unknown. No concomitant medications are reported by the reporter. No treatment information is provided. Patient has an appointment with a rheumatologist for blood work to know more about this reaction. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-227179 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435943
Sex: F
Age:
State: CA

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 06/30/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Ulcerations on the lining of the stomach; Vomiting; Diharrea; This spontaneous case was reported by a patient and describes the occurrence of GASTRIC ULCER (Ulcerations on the lining of the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced GASTRIC ULCER (Ulcerations on the lining of the stomach) (seriousness criterion medically significant), VOMITING (Vomiting) and DIARRHOEA (Diharrea). At the time of the report, GASTRIC ULCER (Ulcerations on the lining of the stomach), VOMITING (Vomiting) and DIARRHOEA (Diharrea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. The patient received treatment for unknown indication.; 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: 1435944
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: high blood pressure; Anxiety disorder attacks; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and ANXIETY DISORDER (Anxiety disorder attacks) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 HYPERTENSION (high blood pressure) (seriousness criterion medically significant) and ANXIETY DISORDER (Anxiety disorder attacks) (seriousness criterion medically significant). At the time of the report, HYPERTENSION (high blood pressure) and ANXIETY DISORDER (Anxiety disorder attacks) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Live Follow-up received on 20-JUN-2021 does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435945
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: My Blood Sugar us OUT OF CONTROL; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetic. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. No treatment information was provided. The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time. Additional information required. The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time. Additional information required.; Sender's Comments: The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time. Additional information required.

Other Meds:

Current Illness: Diabetic

ID: 1435946
Sex: M
Age: 19
State: MO

Vax Date: 06/05/2021
Onset Date: 06/05/2021
Rec V Date: 06/30/2021
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: nose was congested; throat was scratchy; really bad headache; feeling a lot of fatigue/feeling more tired than he usually is; severe allergic reaction/allergic reaction to the vaccine; fingers tingling; tongue felt abnormally large; bumps on his face, back, chest and stomach; pattient felt very uncomfortable; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) in a 19-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 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) (seriousness criteria medically significant and life threatening), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach), FEELING ABNORMAL (pattient felt very uncomfortable) and PAIN IN EXTREMITY (Sore arm). On 18-Jun-2021, the patient experienced NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of 1 dosage form; EPINEPHRINE (EPIPEN) for Allergic reaction, at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 05-Jun-2021, HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach) and FEELING ABNORMAL (pattient felt very uncomfortable) had resolved. On 07-Jun-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use is not provided by the reporter. Reportedly, patient stayed at hospital for one hour until treatment made effect. The patient is thinking whether to take a second dose of moderna or not. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435947
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: developed movements on his right leg and arm / doctors find nothing causing his right leg movements; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) (seriousness criterion hospitalization). At the time of the report, DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment Based on the current available information and temporal association between the use of the product and the start date of the 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: 1435948
Sex: F
Age: 120
State: UT

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 06/30/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Lost vision in one eye; Shngles; Right arm hurt after 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS UNILATERAL (Lost vision in one eye) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A0 and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Immunocompromised and Autoimmune disorder. Previously administered products included for an unreported indication: Shingrix. Concurrent medical conditions included Breast cancer, Heart failure, Lupus syndrome (Lupus) and Shingles. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (Right arm hurt after 2nd dose). In June 2021, the patient experienced HERPES ZOSTER (Shngles). On an unknown date, the patient experienced BLINDNESS UNILATERAL (Lost vision in one eye) (seriousness criterion medically significant). On 07-Feb-2021, MYALGIA (Right arm hurt after 2nd dose) had resolved. At the time of the report, BLINDNESS UNILATERAL (Lost vision in one eye) and HERPES ZOSTER (Shngles) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient took medications for autoimmune conditions and mild pain medication. Consumer got her 1st dose on 05Feb2021 (Lot # 010M20A) and 2nd dose on 05Mar2021 (Lot # 025A21A0. Both doses were administered at her workplace. Consumer states that after receiving both doses, her right arm hurt. The onset was the following day (06Feb2021 and 06Mar2021) and duration was about 24 hours. Consumer states that 1st dose hurt more than 2nd dose. The intensity consumer described was 1st dose hurt 2 times more than tetanus shot. Consumer states she is immunocompromised. She has past medical history of lupus, breast cancer, heart failure, and shingles. Consumer states that she completed the vaccination series for shingles about 3 years ago. Consumer came down with shingles in first part of June (exact dates unknown). She did not know she had shingles until she went for an eye examination. During examination consumer was diagnosed with shingles. Consumer is still recovering from shingles and has lost vision in one eye. Consumer does not blame shingles on the covid-19 vaccine. Consumer did not take any medications to alleviate any possible adverse events, but she did state she take medications for autoimmune conditions and mild pain medication. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding however by prior history of lupus, breast cancer and patient use of "autoimmune medications" not specified and self-reported history of autoimmune disorders and immunodeficiency. . This case was linked to MOD-2021-228299 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding however by prior history of lupus, breast cancer and patient use of "autoimmune medications" not specified and self-reported history of autoimmune disorders and immunodeficiency. .

Other Meds:

Current Illness: Breast cancer; Heart failure; Lupus syndrome (Lupus); Shingles

ID: 1435949
Sex: M
Age: 74
State:

Vax Date: 05/07/2021
Onset Date: 06/07/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Blood clot on his left leg, tibial vein; Entire leg continued to swell; Knee started to swell; This spontaneous case was reported by a nurse and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Blood pressure high, Cholesterol and Depression (antidepressants). Concomitant products included PREDNISONE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced JOINT SWELLING (Knee started to swell). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Entire leg continued to swell). The patient was treated with RIVAROXABAN (XARELTO) at a dose of 15 mg. At the time of the report, DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein), JOINT SWELLING (Knee started to swell) and PERIPHERAL SWELLING (Entire leg continued to swell) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included for High blood pressure, cholesterol, antidepressant. 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: PREDNISONE; ASPIRIN 81

Current Illness: Blood pressure high; Cholesterol; Depression (antidepressants)

ID: 1435950
Sex: F
Age: 61
State: NY

Vax Date: 05/24/2021
Onset Date: 05/25/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: elevated blood pressure readings

Allergies:

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

Symptoms: blood pressure reading have been like a roller coaster, up and down; right arm hurt; Diverticulitis; costochondritis; massive pain in the rib cage area; pressure in the lower abdomen; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8370299) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumonia (missed diagnosis of COVID, treated for pneumonia as there were no COVID tests available.) in February 2020. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), VITAMIN D NOS, PROBIOTICS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen ) and VACCINATION SITE PAIN (right arm hurt). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down). At the time of the report, DIVERTICULITIS (Diverticulitis), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen ), BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down) and VACCINATION SITE PAIN (right arm hurt) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/84 (High) elevated blood pressure readings. 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. Blood tests and CAT scan were done in the ER. Results were not provided. Patient was treated with a 10 day course of two antibiotics. 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: FLONASE [MOMETASONE FUROATE]; VITAMIN D NOS; PROBIOTICS NOS; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1435951
Sex: F
Age: 52
State: WI

Vax Date: 04/02/2021
Onset Date: 05/07/2021
Rec V Date: 06/30/2021
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: Toxoplasmosis of my left eye resurfaced for the first time sine 1996; Gout in my left big toe; Bladder Infection; Shingles; Repeat rheumatoid arthritis flare; Rheumatoid Arthritis Flare; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) and RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Toxoplasmosis (resurfaced in left eye for the first time since 1996). Concomitant products included ABATACEPT (ORENCIA), Prenisone, AZITHROMYCIN (AZO), ESTROGENS CONJUGATED (PREMARIN), LISINOPRIL, AMITRIPTYLINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and VALACYCLOVIR [VALACICLOVIR] 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 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) (seriousness criterion medically significant). On 23-May-2021, the patient experienced RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) (seriousness criterion medically significant). On 25-May-2021, the patient experienced HERPES ZOSTER (Shingles). On 09-Jun-2021, the patient experienced CYSTITIS (Bladder Infection). On 15-Jun-2021, the patient experienced GOUT (Gout in my left big toe). On 18-Jun-2021, the patient experienced TOXOPLASMOSIS (Toxoplasmosis of my left eye resurfaced for the first time sine 1996). On 24-May-2021, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) had resolved. On 01-Jun-2021, HERPES ZOSTER (Shingles) had resolved. On 06-Jun-2021, RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) had resolved. On 14-Jun-2021, CYSTITIS (Bladder Infection) had resolved. At the time of the report, GOUT (Gout in my left big toe) and TOXOPLASMOSIS (Toxoplasmosis of my left eye resurfaced for the first time sine 1996) outcome was unknown. No treatment information provided by the reporter. Very limited information regarding this events has been provided at this time. This case was linked to MOD-2021-228447 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds: ORENCIA; Prenisone; AZO; PREMARIN; LISINOPRIL; AMITRIPTYLINE; PROTONIX [OMEPRAZOLE]; VALACYCLOVIR [VALACICLOVIR]

Current Illness:

ID: 1435952
Sex: U
Age:
State:

Vax Date: 04/19/2021
Onset Date:
Rec V Date: 06/30/2021
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: thrombus in my left foot; my leg swelled up; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (thrombus in my left foot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Factor V deficiency and Anticoagulant therapy. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (thrombus in my left foot) (seriousness criterion medically significant) and PERIPHERAL SWELLING (my leg swelled up). At the time of the report, THROMBOSIS (thrombus in my left foot) had resolved and PERIPHERAL SWELLING (my leg swelled up) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included Blood Thinners. No Treatment medication details was provided. It was reported that The thrombus disappeared after 2 days. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness: Anticoagulant therapy; Factor V deficiency

Date Died:

ID: 1435953
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Death; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (Death) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. 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.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1435954
Sex: M
Age: 59
State: MI

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 06/30/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Arms is a little sore). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) and PAIN IN EXTREMITY (Arms is a little sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information was reported. It was reported that patient is with insulin pump but is not helping. This case concerns a 59-year-old male with a serious unexpected event of diabetes mellitus inadequate control, and non-serious pain in extremity. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 59-year-old male with a serious unexpected event of diabetes mellitus inadequate control, and non-serious pain in extremity. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: INSULIN

Current Illness: Diabetes

ID: 1435955
Sex: F
Age:
State:

Vax Date: 02/24/2021
Onset Date: 03/05/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data: Test Name: Platelet count decreased; Result Unstructured Data: platelets are as low as 3*1000

Allergies:

Symptom List: Injection site pain

Symptoms: acute immune thrombocytopenia; blood spots (hematoma); .immune thrombocytopenic purpura; This spontaneous case was reported by an other health care professional and describes the occurrence of HAEMATOMA (blood spots (hematoma)), IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) and IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immune thrombocytopenia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced HAEMATOMA (blood spots (hematoma)) (seriousness criterion hospitalization) and IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) (seriousness criteria hospitalization and medically significant). On 05-May-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Mar-2021 due to HAEMATOMA. At the time of the report, HAEMATOMA (blood spots (hematoma)), IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) and IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count decreased: decreased (Low) platelets are as low as 3*1000. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 05/Mar/2021, the patient experienced several blood spots on tongue (hematoma). The tiny red spots growing on face and body. The patient thought might have internal bleeding or blood disorder and decided to drove ER (emergency room). On 06/Mar/2021 got admitted, the physician run more than 30 blood draws, the platelet was 3x 1000 it was 240x1000. It was a disease called acute immune thrombocytopenia. No treatment drug information provided.No concomitant drug information provided. This case concerns a female of unknown age hospitalized with serious unexpected events of immune thrombocytopenic purpura, acute immune thrombocytopenia and haematoma. Event latency 10 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age hospitalized with serious unexpected events of immune thrombocytopenic purpura, acute immune thrombocytopenia and haematoma. Event latency 10 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Immune thrombocytopenia

ID: 1435956
Sex: F
Age:
State:

Vax Date: 03/29/2021
Onset Date: 06/19/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She never received her second dose; Suffered from an acute ischemic stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Hyperlipidemia, Type II diabetes mellitus and Atrial fibrillation. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She never received her second dose). At the time of the report, ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) and PRODUCT DOSE OMISSION ISSUE (She never received her second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not reported. Treatment information was unknown. This report refers to a case of Product dose omission issue for mRNA-1273, with associated adverse event of Ischemic stroke. Very limited information regarding this event has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors. Further information has been requested.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, with associated adverse event of Ischaemic stroke.Very limited information regarding this event has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors.Further information has been requested.

Other Meds:

Current Illness: Atrial fibrillation; Hyperlipidemia; Hypertension; Type II diabetes mellitus

ID: 1435957
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: blood clotting; hives; COVID arm; rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021. This spontaneous case was reported by an other and describes the occurrence of THROMBOSIS (blood clotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 THROMBOSIS (blood clotting) (seriousness criterion medically significant), URTICARIA (hives), VACCINATION SITE REACTION (COVID arm) and RASH (rash). At the time of the report, THROMBOSIS (blood clotting), URTICARIA (hives), VACCINATION SITE REACTION (COVID arm) and RASH (rash) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.

Other Meds:

Current Illness:

ID: 1435958
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 06/30/2021
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: Lungs feel worse or congested; one to 3 bloody noses a day; bruising easily; clotting from nose mouth. And sometimes just clotting; headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Lungs feel worse or congested) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (Lungs feel worse or congested) (seriousness criterion medically significant), EPISTAXIS (one to 3 bloody noses a day), CONTUSION (bruising easily), COAGULOPATHY (clotting from nose mouth. And sometimes just clotting) and HEADACHE (headache). At the time of the report, PULMONARY CONGESTION (Lungs feel worse or congested), EPISTAXIS (one to 3 bloody noses a day), CONTUSION (bruising easily), COAGULOPATHY (clotting from nose mouth. And sometimes just clotting) and HEADACHE (headache) had not resolved. Concomitant product use was not reported. Treatment information was not provided. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435959
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: Blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) 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 THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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: 1435960
Sex: M
Age: 80
State: FL

Vax Date: 04/26/2021
Onset Date:
Rec V Date: 06/30/2021
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: Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.). On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435961
Sex: M
Age: 46
State: WA

Vax Date: 03/26/2021
Onset Date: 03/31/2021
Rec V Date: 06/30/2021
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: possible monoreactive arthritis; right knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS REACTIVE (possible monoreactive arthritis) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 044B21A) 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 CORTISONE ACETATE (CORTISONE SHOT) for Inflammation, PREDNISONE and METHOTREXATE for an unknown indication. On 26-Mar-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 31-Mar-2021, the patient experienced ARTHRITIS REACTIVE (possible monoreactive arthritis) (seriousness criterion medically significant) and ARTHRALGIA (right knee pain). At the time of the report, ARTHRITIS REACTIVE (possible monoreactive arthritis) and ARTHRALGIA (right knee pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CORTISONE SHOT; PREDNISONE; METHOTREXATE

Current Illness:

ID: 1435962
Sex: F
Age: 64
State: FL

Vax Date: 05/21/2021
Onset Date: 06/18/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Trouble walking; inability to lift right leg; experienced a headache describing that " an explosion happened in my head; High BP 172/95-98; left arm felt heavy with numbness all the way to fingertips; lethargy; vertigo; Lightheadedness; dehydration; Tingling all the way to fingertips; general fatigue; diarrhea; belching; blurred vision; Mouth dry; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (Lightheadedness), DEHYDRATION (dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (Trouble walking), HYPOKINESIA (inability to lift right leg), BLOOD PRESSURE INCREASED (High BP 172/95-98), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips), LETHARGY (lethargy) and HEADACHE (experienced a headache describing that " an explosion happened in my head) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anaphylaxis, Coronary artery disease, Asthma, Gastroesophageal reflux disease, Osteoarthritis, Hypoglycemia, Hypothyroidism, Hypertension, Allergy to antibiotic (The patient is allergic to Levaquin.), Drug allergy (The patient is allergic to Vioxx.), Shellfish allergy and Arrhythmia. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ASPIRIN [ACETYLSALICYLIC ACID], ATENOLOL (TENORMIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN (NEURONTIN), VITAMIN B12 [VITAMIN B12 NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LEVOSALBUTAMOL TARTRATE (XOPENEX HFA), EPINEPHRINE (EPIPEN), NITROGLYCERIN, ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHYROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) for an unknown indication. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization), DIZZINESS (Lightheadedness) (seriousness criterion hospitalization), DEHYDRATION (dehydration) (seriousness criterion hospitalization), PARAESTHESIA (Tingling all the way to fingertips) (seriousness criterion hospitalization), FATIGUE (general fatigue) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (High BP 172/95-98) (seriousness criterion hospitalization), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips) (seriousness criterion hospitalization), LETHARGY (lethargy) (seriousness criterion hospitalization), DRY MOUTH (Mouth dry) and NAUSEA (nausea). On 19-Jun-2021, the patient experienced HYPOKINESIA (inability to lift right leg) (seriousness criterion hospitalization) and HEADACHE (experienced a headache describing that " an explosion happened in my head) (seriousness criterion hospitalization). On 20-Jun-2021, the patient experienced VISION BLURRED (blurred vision). On 21-Jun-2021, the patient experienced DIARRHOEA (diarrhea) and ERUCTATION (belching). On an unknown date, the patient experienced GAIT DISTURBANCE (Trouble walking) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) ongoing from 21-May-2021 at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo), DIZZINESS (Lightheadedness), DEHYDRATION (dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (Trouble walking), HYPOKINESIA (inability to lift right leg), BLOOD PRESSURE INCREASED (High BP 172/95-98), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips), LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhea), DRY MOUTH (Mouth dry), ERUCTATION (belching) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After the patient received the first dose of the Moderna COVID-19 vaccine on 21 May 2021, the patient reports having a black and blue arm as a side effect from receiving that dose. The patient experienced high BP 172/95-98, which resolved to systolic BP of 155 by the time of discharge from the vaccine facility. The patient's left arm felt heavy with numbness and tingling down the entire arm to the finger tips. At the vaccine facility, the patient was treated with Benadryl and rest until they felt good enough to go home. After arriving home the patient experienced generalized fatigue, continued numbness and tingling of left arm, lightheadedness, increased blood pressure, and lethargy and presented to their local ER where they were treated for dehydration and given meclizine. The decision was made to keep the patient overnight where they were observed and discharged 19 Jun 2021. During their observation period, the patient experienced a headache describing that " an explosion happened in my head" as well as the inability to lift their right leg and trouble walking, which required the use of a wheelchair. There was no report of any additional treatment given for these symptoms. The patient is currently experiencing the above mentioned symptoms intermittently with the addition of: belching, the inability to lift the right leg, and blurred vision (onset 20 Jun 2021) and diarrhea ( onset 21 Jun 2021). The patient has Coronary Artery Disease for which they have three cardiac stents. The patient is Rh NEG. The patient is epileptic and has a cervical spine fusion. The patient is also allergic to steroids. 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: SPIRIVA; ADVAIR; ASPIRIN [ACETYLSALICYLIC ACID]; TENORMIN; COQ10 [UBIDECARENONE]; KEPPRA [LEVETIRACETAM]; NEURONTIN; VITAMIN B12 [VITAMIN B12 NOS]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]; XOPENEX HFA; EPIPEN; NITROGLYCERIN

Current Illness: Allergy to antibiotic (The patient is allergic to Levaquin.); Anaphylaxis; Arrhythmia; Asthma; Coronary artery disease; Drug allergy (The patient is allergic to Vioxx.); Gastroesophageal reflux disease; Hypertension; Hypoglycemia; Hypothyroidism; Osteoarthritis; Shellfish allergy

ID: 1435963
Sex: M
Age:
State: RI

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: MRI; Result Unstructured Data: stroke

Allergies:

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

Symptoms: lost short term memory temporally; sight was affected; Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory; teeth were chattering/chills; fever; headache; a numbness in the jaw and his hand; lips tingling; left arm was weak; arm were tingling and left arm was tingling; face was red; felt like crap; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History details provided. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (a numbness in the jaw and his hand), PARAESTHESIA ORAL (lips tingling), MUSCULAR WEAKNESS (left arm was weak), PARAESTHESIA (arm were tingling and left arm was tingling), ERYTHEMA (face was red), FEELING ABNORMAL (felt like crap), PYREXIA (fever) and HEADACHE (headache). On 18-Apr-2021, the patient experienced CHILLS (teeth were chattering/chills). On 08-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced AMNESIA (lost short term memory temporally) and VISUAL IMPAIRMENT (sight was affected). The patient was treated with ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency and CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency. On 17-Apr-2021, HYPOAESTHESIA (a numbness in the jaw and his hand), PARAESTHESIA ORAL (lips tingling), MUSCULAR WEAKNESS (left arm was weak) and PARAESTHESIA (arm were tingling and left arm was tingling) had resolved. On 18-Apr-2021, ERYTHEMA (face was red), FEELING ABNORMAL (felt like crap), PYREXIA (fever) and HEADACHE (headache) had resolved. On 20-Apr-2021, CHILLS (teeth were chattering/chills) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: stroke (abnormal) stroke. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. Patient taking unknown medications for anxiety. Patient was admitted to a clinic one afternoon on an unknown date ,had a cat scan and was overnight in observation. The next day he was discharged. Following week he had MRI, Battery of tests to his heart: to his carotid arteries are being done,"bubble test", he is wearing a 30-day monitor; they will also be performing a sleep apnea test. 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: 1435964
Sex: F
Age: 47
State: MN

Vax Date: 06/19/2021
Onset Date: 06/19/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: she was admitted to hospital due to big reaction after getting the first shot; nausea; the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Epilepsy and Vertigo (Get really dizzy.). Concomitant products included LAMOTRIGINE (LAMICTAL), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and CARBAMAZEPINE (TEGRETOL) for an unknown indication. On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot) (seriousness criterion hospitalization) and DIZZINESS (the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going). On an unknown date, the patient experienced NAUSEA (nausea). The patient was hospitalized on 19-Jun-2021 due to VACCINATION SITE REACTION. At the time of the report, VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot), DIZZINESS (the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 20-Jun-2021 patient went to the hospital and had blood work done but no results were reported. Treatment reported is unknown nausea medication. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LAMICTAL; KEPPRA [LEVETIRACETAM]; TEGRETOL

Current Illness:

ID: 1435965
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Faint; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. Very limited information regarding this event has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435966
Sex: M
Age:
State:

Vax Date: 05/22/2021
Onset Date: 05/24/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: blood levels; Result Unstructured Data: high protein numbers; Test Date: 2021; Test Name: EKG; Result Unstructured Data: diagnosis of myocarditis; Test Date: 2021; Test Name: sacns; Result Unstructured Data: diagnosis of myocarditis

Allergies:

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

Symptoms: developed heart pain down both arms; myocarditis, every time his heart beat it hurt and he felt pressure; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (developed heart pain down both arms) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDITIS and PAIN IN EXTREMITY. At the time of the report, MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: high (High) high protein numbers. In 2021, Electrocardiogram: abnormal (abnormal) diagnosis of myocarditis. In 2021, Scan: abnormal (abnormal) diagnosis of myocarditis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment information was not given. No concomitant medication information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Very limited information has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435967
Sex: F
Age:
State: TX

Vax Date: 01/03/2021
Onset Date:
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data: Test Name: blood work; Result Unstructured Data: blood count showed zero platelets; Test Name: Blood test; Result Unstructured Data: completely normal blood-test results less than a week before being vaccinated

Allergies:

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

Symptoms: her blood count showed zero platelets; heavy vaginal bleeding; red spots under ankle and wrists; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (her blood count showed zero platelets) in a 48-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 03-Jan-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 THROMBOCYTOPENIA (her blood count showed zero platelets) (seriousness criteria hospitalization and medically significant), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and PURPURA (red spots under ankle and wrists). At the time of the report, THROMBOCYTOPENIA (her blood count showed zero platelets), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and PURPURA (red spots under ankle and wrists) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) blood count showed zero platelets and normal (normal) completely normal blood-test results less than a week before being vaccinated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had a checkup with completely normal blood-test results less than a week before being vaccinated. Patient had spent four days in the hospital, receiving platelet transfusions, immune globulins and steroids to restore her platelet count. Concomitant medication were 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. Further information has been requested 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. Further information has been requested

Other Meds:

Current Illness:

ID: 1435968
Sex: M
Age:
State: AZ

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: severe heart burn; overall not feeling well; This is a spontaneous report from a contactable consumer or other non HCP (patient himself). A 70-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el8982), via an unspecified route of administration, administered in Left arm on 03Feb2021 12:00 PM (at the age of 70-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies to medications, food or other products. the patient received medications within 2 weeks of vaccination included blood pressure medication (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 at 06:00 PM, the patient experienced severe heart burn and overall not feeling well. The events were reported as non-serious. No treatment received for the adverse event. The outcome of the events were not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1435969
Sex: F
Age:
State: OH

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 06/30/2021
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: I awoke numerous times; chills; experienced difficulty breathing; Nauseated; increased muscle pain; joint pain; dizziness; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration in right arm on 03Feb2021 at 11:30 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history included multiple sclerosis. Patient was allergic to latex. The patient concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021 at 08:00, approximately 20 hours after receiving the Pfizer vaccination patient noticed increased muscle and joint pain with an accompanying dizziness. At approximately 30 hours after injection, patient skipped dinner due to sleeping, got up and went back to bed. During the night, patient awoke numerous times with chills but more importantly, experienced difficulty breathing and nauseated. Any treatment received for adverse event was unknown.The outcome of event was recovering. Information on the lot/batch number has been requested. 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:

ID: 1435970
Sex: F
Age:
State: MA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 06/30/2021
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: Chills; fever; achy all over; skin hurts to touch; very tired; This is a spontaneous report from a contactable consumer. A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 04Feb2021 07:30 (at the age of 46-years-old) as dose 2, single for covid-19 immunisation in hospital. Medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK9231, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 01Jan2021 07:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Feb2021 at 14:00, the patient experienced chills, fever, achy all over, skin hurts to touch and very tired. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse events. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1435971
Sex: F
Age:
State: FL

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 06/30/2021
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: achiness; slight headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in arm right on 27Jan2021 10:15 (at the age of 73-years-old) as dose 1, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (copd), high blood pressure (high bp), high cholesterol, essential tremor, gastroesophageal reflux disease (gerd), arthritis. The patient previously took Macrobid [nitrofurantoin] and experienced drug hypersensitivity (Allergies to medications, food, or other products: macrobid). Concomitant medication included propranolol (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; atorvastatin (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; pantoprazole (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; Olmesartan (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021 13:30, the patient experienced achiness, slight headache, nausea. The patient did not receive any treatment for the adverse event. The reported seriousness of the events was non-serious. The clinical outcome of the events was recovered in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds: PROPRANOLOL; ATORVASTATIN; PANTOPRAZOLE; OLMESARTAN

Current Illness:

ID: 1435972
Sex: F
Age:
State: VA

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 06/30/2021
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: Painful itchy circumferential rash on the entire torso; Itchiness in limbs; Painful itchy circumferential rash on the entire torso; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN5318 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 at 14:30 (at the age of 53-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has allergy to Bactrim and Pneumococcal vaccine. Patient previously took first dose of bnt162b2 on an unknown date for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Also since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 at 12:00, the patient experienced painful itchy circumferential rash on the entire torso and itchiness in limbs. No treatment was received for the events. At the time of reporting, the outcome of the events were not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1435973
Sex: M
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 01/31/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data: Test Date: 20210131; Test Name: Body temperature; Result Unstructured Data: Test Result:102.3 Fahrenheit; Comments: from 7 pm until 02Jan2021 afternoon,I had a fever; Test Date: 20210201; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: lower back muscle soreness; fever; chills/chattering teeth; This is a spontaneous report from a contactable other hcp. This HCP reported for himself that a 31-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9263), dose 1 intramuscular, administered in Arm Right on 26Jan2021 16:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021 19:00, the patient experienced lower back muscle soreness; fever and chills/chattering teeth. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 102.3 fahrenheit on 31Jan2021 from 7 pm until 02Jan2021 afternoon,I had a fever, sars-cov-2 test: negative on 01Feb2021. It was reported that on 31Jan2021 from 07:00 pm until 01Feb2021 afternoon, patient had a fever of 102.3 degrees F with chills, chattering teeth and lower back muscle soreness. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The clinical outcome of all events were recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1435974
Sex: M
Age:
State: FL

Vax Date: 01/03/2021
Onset Date: 01/09/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data: Test Date: 20210109; Test Name: Blood sugar; Result Unstructured Data: Test Result:Stayed lower; Comments: Blood sugar has stayed lower and short term insulin use is reduced also.

Allergies:

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

Symptoms: Blood sugar has stayed lower; This is a spontaneous report from a contactable consumer (patient himself). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: eh9899) via an unspecified route of administration, administered in arm left on 03Jan2021 (at the age of 66-year-old) as dose number unknown, single for covid-19 immunisation.Medical history included diabetes, high blood pressure and high cholesterol. Concomitant medications included insulin taken for an unspecified indication and other medication (unspecified) was received within 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 09Jan2021,the patient reported that, two weeks after the shot, upon review of my glucose meter my endocrinologist reduced the amount of long-acting insulin by 25 percentage. Blood sugar had stayed lower, and the treatment short term insulin use was reduced also. The patient visited doctor or other healthcare professional office/clinic visit. On 09Jan2021, the patient lab data included blood sugar had stayed lower and short-term insulin use is reduced also. The outcome of the event was unknown. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected. Follow-up attempts completed. No further information expected.

Other Meds: INSULIN

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am