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: 1678167
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Sore throat common; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat common) 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 OROPHARYNGEAL PAIN (Sore throat common). At the time of the report, OROPHARYNGEAL PAIN (Sore throat common) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported No Treatment information was reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1678168
Sex: F
Age: 36
State: AR

Vax Date: 01/18/2021
Onset Date: 01/25/2021
Rec V Date: 09/07/2021
Hospital: Y

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: Extreme Hair loss/bad hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Extreme Hair loss/bad hair loss) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2021, the patient experienced ALOPECIA (Extreme Hair loss/bad hair loss) (seriousness criterion hospitalization). At the time of the report, ALOPECIA (Extreme Hair loss/bad hair loss) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant product use was not provided by the reporter. A week after receiving first dose, patient began to fall out in big clumps. Patient once had long thick hair, 8 months later her hair was so bald. Patient had to wear a wig. It came out in clumps of hair which had never happened in her life. On 16-Feb-2021, received second dose. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant follow up - verbatam added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1678169
Sex: M
Age: 67
State: PR

Vax Date: 05/04/2021
Onset Date: 05/06/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Did not get the second dose because of this symptoms; Symptoms of Parkinson's worsened after the shot; Felt weak/suddenly lost his strength and he needed to sit down or lay down; Couldn't even take a bath; Could not stand up or walk; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (Symptoms of Parkinson's worsened after the shot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Parkinson's disease (since 6 years) since 2015. Concomitant products included CARBIDOPA, ENTACAPONE, LEVODOPA (CARBIDOPA, LEVODOPA AND ENTACAPONE), PRAMIPEXOL [PRAMIPEXOLE] and CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) for Parkinson's disease, CIPROFLOXACIN HCL, ESCITALOPRAM, ENALAPRIL, TAMSULOSIN HCL and DONEPEZIL for an unknown indication. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PARKINSON'S DISEASE (Symptoms of Parkinson's worsened after the shot) (seriousness criterion medically significant), ASTHENIA (Felt weak/suddenly lost his strength and he needed to sit down or lay down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't even take a bath) and GAIT INABILITY (Could not stand up or walk). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Did not get the second dose because of this symptoms). In August 2021, GAIT INABILITY (Could not stand up or walk) had resolved. At the time of the report, PARKINSON'S DISEASE (Symptoms of Parkinson's worsened after the shot), ASTHENIA (Felt weak/suddenly lost his strength and he needed to sit down or lay down) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't even take a bath) was resolving and INTENTIONAL PRODUCT USE ISSUE (Did not get the second dose because of this symptoms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient stated that his Parkinson's disease was under control with medication prior to taking the vaccine. Post vaccination he would spend up to 8 hours in bed. His symptoms persisted till around 20-Jun-2021 when he started to get slowly better but had still not recovered 100%. Prior to vaccination, he would take his medications regularly and lived a normal life. His doctor told him to get the second dose and was scheduled for the same on 31-Aug-2021. Company comment: This report refers to a case of Intentional product use issue for mRNA-1273 (lot # 017C21A) with associated adverse events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: This report refers to a case of Intentional product use issue for mRNA-1273 (lot # 017C21A) with associated adverse events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.

Other Meds: CARBIDOPA, LEVODOPA AND ENTACAPONE; PRAMIPEXOL [PRAMIPEXOLE]; SINEMET; CIPROFLOXACIN HCL; ESCITALOPRAM; ENALAPRIL; TAMSULOSIN HCL; DONEPEZIL

Current Illness: Parkinson's disease (since 6 years)

ID: 1678170
Sex: M
Age: 17
State:

Vax Date: 06/06/2021
Onset Date: 06/06/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: medical condition; 17 year old given vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ILL-DEFINED DISORDER (medical condition) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009A21A and 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given vaccine.). On an unknown date, the patient experienced ILL-DEFINED DISORDER (medical condition) (seriousness criterion hospitalization). On 05-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given vaccine.) had resolved. At the time of the report, ILL-DEFINED DISORDER (medical condition) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 (lot 009A21A and 038C21A) with associated unspecified adverse event. Very limited information regarding this event has been provided at this time. Further information regarding temporal association and indication for Hospitalization is necessary to assess causality.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 (lot 009A21A and 038C21A) with associated unspecified adverse event. Very limited information regarding this event has been provided at this time. Further information regarding temporal association and indication for Hospitalization is necessary to assess causality.

Other Meds:

Current Illness:

ID: 1678171
Sex: M
Age:
State: NC

Vax Date: 02/25/2021
Onset Date: 03/02/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: liquid retention on the right leg; aortic valvle replacement. 2nd process, because of a "leaking valvle; difficult breathing. He was admited in ER.; pneumonia; He never get the 2nd dose of Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia), DYSPNOEA (difficult breathing. He was admited in ER.), HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) and FLUID RETENTION (liquid retention on the right leg) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumonia, Thoracic cavity drainage on 04-Mar-2021 and Aortic valve replacement (Replacement 2nd process, because of leaking valve) on 29-Mar-2021. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (difficult breathing. He was admited in ER.) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) (seriousness criterion hospitalization). In 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FLUID RETENTION (liquid retention on the right leg) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (He never get the 2nd dose of Moderna.). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficult breathing. He was admited in ER.), HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) and FLUID RETENTION (liquid retention on the right leg) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He never get the 2nd dose of Moderna.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. On 4 March2021 Doctor performed a thoracic drainage,On 29 march patient went to the hospital for aortic valve replacement 2nd process, because of leaking valve and patient suffered with liquid retention on the right leg. Company Comment This is a case of Product dose omission of a 75 year old male patient. Very limited information regarding the events have been provided at this time. Patient's history of Pneumonia may be a confounding factor. Further information has been requested.; Sender's Comments: This is a case of Product dose omission of a 75 year old male patient. Very limited information regarding the events have been provided at this time. Patient's history of Pneumonia may be a confounding factor. Further information has been requested.

Other Meds:

Current Illness:

ID: 1678172
Sex: F
Age: 59
State: TX

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 09/07/2021
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: Test Name: spinal test; Test Result: Positive ; Result Unstructured Data: positive for Guillain-Barre syndrome

Allergies:

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

Symptoms: Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal X-ray: positive (Positive) positive for Guillain-Barre syndrome. No concomitant medications information was reported. No treatment medications were provided. Company Comment: This report refers to a case of Guillan-Barre syndrome in a 60-year old female which developed after vaccinating with second dose of mRNA-1273. 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: This report refers to a case of Guillan-Barre syndrome in a 60-year old female which developed after vaccinating with second dose of mRNA-1273. 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: 1678173
Sex: F
Age: 49
State: CT

Vax Date: 12/23/2020
Onset Date: 08/27/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Date: 20210828; Test Name: Doppler test; Result Unstructured Data: Confirmed a blood clot in the left leg

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Confirmed a blood clot in the left leg; Like a "Charlie Horse"; left leg started to feel pain; Left leg swelled; Left leg got hot; Soreness on the left calf muscle/like a sore muscle; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (Confirmed a blood clot in the left leg) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle). On 28-Aug-2021, the patient experienced THROMBOSIS (Confirmed a blood clot in the left leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Confirmed a blood clot in the left leg), MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Ultrasound Doppler: abnormal (abnormal) Confirmed a blood clot in the left leg. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medication was reported as birth control pills. She went to see her physician on 28-Aug-2021, and her doctor performed a Doppler test and test confirmed a blood clot in the left leg. She was prescribed Xarelto and will need to take the medication for three months. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested. This case was linked to MOD-2021-003812 (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. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested.

Other Meds:

Current Illness: Drug allergy

ID: 1678174
Sex: M
Age: 77
State: OH

Vax Date: 01/26/2021
Onset Date: 02/23/2021
Rec V Date: 09/07/2021
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: Rheumatoid arthritis (RA) flare up/RA was pretty intense; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20M) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Aug-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) (seriousness criterion medically significant). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) outcome was unknown. Concomitant medications includes medications for blood pressure and Cholesterol. No treatment medications reported. Patient experienced a Rheumatoid arthritis flare up that started on same arm. On 26 Aug 2021 and 27 Aug 2021, it was pretty intense. Patient had 2nd shot with batch number 0022MZ0A or 00ZZMZ0A. Patient's medical history included blood pressure abnormal and cholesterol abnormal 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. Event of Rheumatoid Arthritis was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. Follow up information is expected for further assessment of this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of Rheumatoid Arthritis was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. Follow up information is expected for further assessment of this event.

Other Meds:

Current Illness:

ID: 1678175
Sex: M
Age: 18
State: NV

Vax Date: 07/27/2021
Onset Date: 08/29/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: myocardial infarction / heart attack; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction / heart attack) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced MYOCARDIAL INFARCTION (myocardial infarction / heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 29-Aug-2021 to 30-Aug-2021 due to MYOCARDIAL INFARCTION. On 30-Aug-2021, MYOCARDIAL INFARCTION (myocardial infarction / heart attack) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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: 1678176
Sex: F
Age: 57
State: CA

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 09/07/2021
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 Name: Thyroid level; Result Unstructured Data: Thyroid level sky rocket high at +23

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Thyroid eye disease; Did not feel good; Can't work,Can't live,Can't see, her life is a living ,ruined her life; Can't live,Can't see, her life is a living ,ruined her life; Can?t see; can't drive; This spontaneous case was reported by a consumer and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) and BLINDNESS (Can?t see) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease) (seriousness criterion medically significant), FEELING ABNORMAL (Did not feel good) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), BLINDNESS (Can?t see) (seriousness criterion medically significant) and IMPAIRED DRIVING ABILITY (can't drive). At the time of the report, ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life), BLINDNESS (Can?t see) and IMPAIRED DRIVING ABILITY (can't drive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: +23 (High) Thyroid level sky rocket high at +23. No concomitant medication information was mentioned by reporter Synthroid 1mg used as a treatment medication then dose of Synthroid was changed it to 0.88mg. 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: 1678177
Sex: U
Age:
State:

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Name: blood pressure increased; Result Unstructured Data: abnormal; Comments: I never had high blood preasure prior to the vaccination.

Allergies:

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

Symptoms: gallbladder issues which result in having it removed; diagnose of hypertension after vaccination; Gallbladder disorder; This spontaneous case was reported by a consumer and describes the occurrence of CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder) 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. In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder). At the time of the report, CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: abnormal (abnormal) abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Company Comment This case concerns a patient who experienced gallbladder disorder and hypertension following administration of mRNA-1273 . Very limited information was provided. Further information has been requested. Based on current available information and plausible temporal relationship between product use and onset of the events, causal role cannot be excluded.; Sender's Comments: This case concerns a patient who experienced gallbladder disorder and hypertension following administration of mRNA-1273 . Very limited information was provided. Further information has been requested. Based on current available information and plausible temporal relationship between product use and onset of the events, causal role cannot be excluded.

Other Meds:

Current Illness:

ID: 1678178
Sex: F
Age: 19
State: AL

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 09/07/2021
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: Sulfur Amoxicillin Z-pac Gluten Lactose

Symptom List: Rash, Urticaria

Symptoms: Fever, chills, body aches, headache, vomiting all within of 4 hours of getting the vaccine. Taken Tylenol, zofran, and dicyclomine

Other Meds: Zoloft Birth control

Current Illness: No

ID: 1678179
Sex: F
Age: 72
State: IN

Vax Date: 01/23/2021
Onset Date: 02/06/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: EKG, labs

Allergies: NKA

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

Symptoms: Sore arm, tingling all over. Fatigue, palpitations, tachycardia, weight loss

Other Meds: Lisinopril

Current Illness: Arthritis

ID: 1678180
Sex: M
Age: 56
State: SC

Vax Date: 09/01/2021
Onset Date: 09/02/2021
Rec V Date: 09/07/2021
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: No

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

Symptoms: Fever of 103, headache, body aches, vomiting, tiredness lasting for 5 days

Other Meds: Insulin, metformin

Current Illness: Diabetes

ID: 1678181
Sex: F
Age: 26
State: NY

Vax Date: 07/29/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data: Troponin level of 3.2 when I went to the ER (8/2), MRI on 8/2 which revealed inflammation in the myocardium. Elevated CRP, elevated ESR levels. I also received an echo, EKG, and was attached to a holter monitor.

Allergies: None

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

Symptoms: I was hospitalized for myocarditis. It started Sunday 8/1 with chest tightness and then pain under my jaw. I went in Monday morning to the ER and was hospitalized for 3 days. I was diagnosed with myocarditis related to the COVID vaccine.

Other Meds: Daily multivitamin and birth control pill

Current Illness: None

ID: 1678189
Sex: M
Age:
State:

Vax Date: 07/30/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cough; shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), PYREXIA (fever) and COUGH (Cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Liver carcinoma. No Medical History information was reported. On 30-Jul-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 8 milligram once a day. On an unknown date, the patient received third 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 and 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 CHILLS (shivering), PYREXIA (fever) and COUGH (Cough). At the time of the report, CHILLS (shivering), PYREXIA (fever) and COUGH (Cough) had resolved. Unknown Patient started drug therapy of Lenvima for lung cancer due to which patient experienced adverse events stated as increase in blood pressure- improved; constipation/stomach bloating - on and off since last report. In follow-up New report stated occasional "knot in the middle of chest/6 out of 10 pain level/at times, after a meal", stomatitis, on and off lower back pain, abdominal pain (affecting night sleep)- MD aware and it was advised patient to miss one dose and take Lenvima in the morning (night sleep- improved). Patient recently also had Flu Vaccine. Patient was prescribed with magic mouthwash for relief of stomatitis. Treatment product information was not provided. Concomitant product use was not provided.

Other Meds: LENVIMA

Current Illness:

ID: 1678237
Sex: F
Age: 68
State: IA

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headaches severe; tiredness; body aches; dizziness; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), LETHARGY (lethargy), HEADACHE (Headaches severe), FATIGUE (tiredness) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Rotator cuff tear, Arthritis and Knee replacement. Concurrent medical conditions included Osteoporosis, COPD, Hypertension, Drug allergy (Melaxicom) and Drug allergy (tramadol). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), IRON and PANTOPRAZOLE for an unknown indication. On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches). On 18-Aug-2021, the patient experienced HEADACHE (Headaches severe) and FATIGUE (tiredness). On 21-Aug-2021, DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (Headaches severe) and FATIGUE (tiredness) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product also included Vitamin D4. No treatment medications reported. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up was received and patient details, relevant medical history, concomitant products and events were updated.

Other Meds: LOSARTIN; IRON; PANTOPRAZOLE

Current Illness: COPD; Drug allergy (tramadol); Drug allergy (Melaxicom); Hypertension; Osteoporosis

ID: 1678239
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: anaphylaxis; This spontaneous report was received from a pharmacist via Pfizer and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was unknown. The event of anaphylactic reaction was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). Upon internal review, the event of anaphylactic reaction was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1678241
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: My friend got the shot in April,/ In November she got the Shingles really bad/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, between 6 and 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shot in April and in November she got the Shingles really bad for about four months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. The case had been linked with US2021AMR187284 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR187284:same reporter

Other Meds:

Current Illness:

ID: 1678242
Sex: F
Age:
State: TN

Vax Date: 03/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: 186 over 108, sent to the hospital because of her blood pressure and heart rate; Test Name: Heart rate; Result Unstructured Data: Sent to the hospital because of her blood pressure and heart rate

Allergies:

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

Symptoms: Two huge lymph nodes in lungs (both); Both her knees down to her feet are swollen; Hot to the touch; Six spots that are really really red; Can not walk; One huge lymph protruding from the side of her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red) and GAIT INABILITY (Can not walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck). On an unknown date, the patient experienced PULMONARY MASS (Two huge lymph nodes in lungs (both)). At the time of the report, PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 186 (High) 186 over 108, sent to the hospital because of her blood pressure and heart rate. On an unknown date, Heart rate: 117 (High) Sent to the hospital because of her blood pressure and heart rate. Concomitant medication use information was provided by reporter that includes Blood pressure medicine. Treatment medication use information was not provided by reporter. Patient was healthy up until the shot. Patient reported that side effects were not improving even though was seen by physicians. Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up received on 29- Aug-2021, added reporter contact details, event outcome updated from unknown to not recovered , added information in I narrative.

Other Meds:

Current Illness:

Date Died:

ID: 1678243
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative from social media (Twitter) concerned multiple (two female) patients. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. Batch numbers were not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, multiple (two) patients developed blood clots. As per the reporter, "We already know JnJ had to halt Vax distribution temporarily because of 2 reported deaths from blood clots in women". Patients died on unspecified date(s). It was not reported if an autopsy was performed. Action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210902860- covid-19 vaccine ad26.cov2.s-Blood Clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOTS

Other Meds:

Current Illness:

ID: 1678244
Sex: U
Age:
State: FL

Vax Date:
Onset Date: 04/15/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: ANGIO EDEMA; SEVERE URTICARIA; This spontaneous report received from a physician concerned a 64 year old patient of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, rosacea, and shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 15-APR-2021, one month post vaccination, patient experienced severe urticaria. On 02-SEP-2021, patient experienced angio-edema and was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe urticaria and angio-edema was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210908058-covid-19 vaccine ad26.cov2.s- Angio-edema. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210908058-covid-19 vaccine ad26.cov2.s- Severe urticaria. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Hypothyroidism; Rosacea; Shellfish allergy

ID: 1678245
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SHORTNESS OF BREATH / HARD TO BREATH; COLD; CANT KEEP EYES OPEN; SORE ARM; FEVER; SEVER HEADACHE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shortness of breath / hard to breath, cold, cant keep eyes open, sore arm, fever, and sever headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sever headache, shortness of breath / hard to breath, fever, cold, sore arm and cant keep eyes open was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1678246
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced asymptomatic covid-19. The action taken with covid-19 vaccine was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1678247
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Acne; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Acne) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Acne). The patient was treated with DOXYCYCLINE ongoing since an unknown date for Acne, at an unspecified dose and frequency. At the time of the report, ACNE (Acne) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported . Caller stated that she, Knows a lot of people on antibiotics who get the vaccine

Other Meds:

Current Illness:

ID: 1678248
Sex: M
Age: 69
State: WI

Vax Date: 07/21/2021
Onset Date: 08/21/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window). On 21-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. No Treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received and contains No New Information. On 25-Aug-2021: Follow up received added patient demographics (patient race), Second dose details(Route and site of administration).

Other Meds:

Current Illness:

ID: 1678249
Sex: M
Age:
State: AR

Vax Date: 07/23/2021
Onset Date:
Rec V Date: 09/07/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19) 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 23-Jul-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 COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19). At the time of the report, COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, their doctor told they should wait 90 days after their symptoms gone, and pharmacist referred them to Moderna. They haven't received the 2nd dose yet. No concomitant medication was reported. The treatment information was unknown. This case was linked to MOD-2021-294322 (Patient Link).

Other Meds:

Current Illness:

ID: 1678250
Sex: M
Age: 42
State: NY

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 09/07/2021
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: he was very anxious, his anxiety level went through the roof; Tightness in his chest; He had pins and needles/He had pins and needles in his hair; it felt like he put charcoal on his skin a few times; he had to call in sick; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 036A21A) for COVID-19 vaccination. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick). At the time of the report, ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick) outcome was unknown. Patient reported that he took multivitamins every third day. This case was linked to MOD-2021-295014 (Patient Link).

Other Meds: ADVIL [IBUPROFEN]

Current Illness:

ID: 1678251
Sex: F
Age: 69
State: MA

Vax Date: 02/26/2021
Onset Date: 03/05/2021
Rec V Date: 09/07/2021
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: She started with chronic insomnia 1 week after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose). At the time of the report, INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment reported This case was linked to MOD-2021-294919 (Patient Link).

Other Meds: LEVOTHYROXINE; ATORVASTATIN

Current Illness:

ID: 1678252
Sex: F
Age: 59
State: NY

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/07/2021
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: throat was swollen; hard time trying to swallow; hard time trying to breath; headache; nausea; fever, close to 104?F after the third dose; had pain in their muscles/body aches/body pain still,; pain in their joints; developed a very strong reaction with a wide range of symptoms; everything was painful, painful to lay down, painful to walk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow) and DYSPNOEA (hard time trying to breath) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication. On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), MYALGIA (had pain in their muscles/body aches/body pain still,) and ARTHRALGIA (pain in their joints). On 20-Aug-2021 at 7:30 PM, the patient experienced PYREXIA (fever, close to 104?F after the third dose). On 21-Aug-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Aug-2021, the patient experienced PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow) and DYSPNOEA (hard time trying to breath). The patient was treated with PARACETAMOL (TYLENOL) on 21-Aug-2021 for Pain, at a dose of 1 dosage form. On 24-Aug-2021, VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow), DYSPNOEA (hard time trying to breath), PYREXIA (fever, close to 104?F after the third dose), MYALGIA (had pain in their muscles/body aches/body pain still,), ARTHRALGIA (pain in their joints), HEADACHE (headache) and NAUSEA (nausea) had resolved. This case was linked to MOD-2021-294965 (Patient Link).

Other Meds: AVANTAR

Current Illness: Immunocompromised; Scleroderma

ID: 1678253
Sex: F
Age: 59
State: NY

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: foggy brained after second dose; sore arm after second dose; 104?F pretty high fever for a a day and a half,; They were also tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose), PYREXIA (104?F pretty high fever for a a day and a half,) and FATIGUE (They were also tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose) and PYREXIA (104?F pretty high fever for a a day and a half,). 2021, the patient experienced FATIGUE (They were also tired). At the time of the report, FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose), PYREXIA (104?F pretty high fever for a a day and a half,) and FATIGUE (They were also tired) outcome was unknown. No treatment details were provided by reporter. This case was linked to MOD-2021-294926, MOD-2021-294974 (Patient Link).

Other Meds: AVANTAR

Current Illness: Immunocompromised; Scleroderma

ID: 1678254
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Dose was given from a open vial 9 day out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given from a open vial 9 day out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given from a open vial 9 day out). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose was given from a open vial 9 day out) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1678255
Sex: F
Age:
State: AL

Vax Date: 07/25/2021
Onset Date: 08/06/2021
Rec V Date: 09/07/2021
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: had the same thing( arm was red, hot, hard and itchy at injection site); had the same thing( arm was red, hot, hard and itchy at injection site); had the same thing( arm was red, hot, hard and itchy at injection site); had the same thing( arm was red, hot, hard and itchy at injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (had the same thing( arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (had the same thing( arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (had the same thing( arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (had the same thing( arm was red, hot, hard and itchy at injection site)) 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 25-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced INJECTION SITE WARMTH (had the same thing( arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (had the same thing( arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (had the same thing( arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (had the same thing( arm was red, hot, hard and itchy at injection site)). At the time of the report, INJECTION SITE WARMTH (had the same thing( arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (had the same thing( arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (had the same thing( arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (had the same thing( arm was red, hot, hard and itchy at injection site)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment history was reported. No concomitant medications were reported

Other Meds:

Current Illness:

ID: 1678256
Sex: M
Age: 25
State: CA

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 09/07/2021
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: not able to get the second dose; left arm felt numb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (left arm felt numb) and PRODUCT DOSE OMISSION ISSUE (not able to get the second dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No Medical History information was reported. On 16-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 VACCINATION SITE ANAESTHESIA (left arm felt numb). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to get the second dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Numbness, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ANAESTHESIA (left arm felt numb) and PRODUCT DOSE OMISSION ISSUE (not able to get the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1678257
Sex: M
Age: 34
State: PA

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 09/07/2021
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: fever; sick; did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-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 PYREXIA (fever), ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose). At the time of the report, PYREXIA (fever), ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1678258
Sex: U
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/07/2021
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: Have had a pretty nasty headache since that just won't go away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Have had a pretty nasty headache since that just won't go away) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In August 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 HEADACHE (Have had a pretty nasty headache since that just won't go away). At the time of the report, HEADACHE (Have had a pretty nasty headache since that just won't go away) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1678259
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Date: 202101; Test Name: Blood pressure; Result Unstructured Data: Elevated BP

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpatations) 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.In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (Heart palpatations). At the time of the report, PALPITATIONS (Heart palpatations) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: high (High) Elevated BP.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were provided by reporter. No treatment medications were provided by reporter. Additional information reported include that the patient was asking whether be vaccinated further and to mention the vaccine name as well.

Other Meds:

Current Illness:

ID: 1678260
Sex: M
Age:
State: PA

Vax Date: 06/14/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Didn't get the 2nd dose yet/more than 36 days from 1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose yet/more than 36 days from 1st vaccination) 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 14-Jun-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 PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose yet/more than 36 days from 1st vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose yet/more than 36 days from 1st vaccination) 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. No concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1678261
Sex: M
Age: 60
State: TX

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: After receiving 1st dose, he had little soreness, pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving 1st dose, he had little soreness, pain in right arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 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 PAIN IN EXTREMITY (After receiving 1st dose, he had little soreness, pain in right arm). At the time of the report, PAIN IN EXTREMITY (After receiving 1st dose, he had little soreness, pain in right arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were reported. No treatment details were reported. This case was linked to MOD-2021-296101 (Patient Link).

Other Meds:

Current Illness:

ID: 1678262
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccime side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccime side effects) 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 VACCINATION COMPLICATION (Vaccime side effects). At the time of the report, VACCINATION COMPLICATION (Vaccime side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1678263
Sex: M
Age: 73
State: AZ

Vax Date: 01/19/2021
Onset Date: 08/23/2021
Rec V Date: 09/07/2021
Hospital:

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: Body temperature; Result Unstructured Data: 100 degrees

Allergies:

Symptom List: Pain in extremity

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizzy/ dizziness), FATIGUE (feeling tired/ exhausted), PYREXIA (He had fever of 100 degrees/ experienced temperature) and EXTRA DOSE ADMINISTERED (he received the third dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Heart attack, Enlarged prostate and Non-Hodgkin's lymphoma (He had cancer 20 years ago). Concurrent medical conditions included Depression and Blood pressure abnormal (Blood pressure).On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizzy/ dizziness), FATIGUE (feeling tired/ exhausted) and PYREXIA (He had fever of 100 degrees/ experienced temperature). On 23-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (he received the third dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Aug-2021, EXTRA DOSE ADMINISTERED (he received the third dose) had resolved. At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizzy/ dizziness), FATIGUE (feeling tired/ exhausted) and PYREXIA (He had fever of 100 degrees/ experienced temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) 100 degrees. No concomitant medications were reported. Patient reported that he did not experience any adverse events with the first two doses.

Other Meds:

Current Illness: Blood pressure abnormal (Blood pressure); Depression

ID: 1678264
Sex: M
Age: 50
State: WV

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccine administered from a vial that has possibly been punctured for 48 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that has possibly been punctured for 48 hours.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that has possibly been punctured for 48 hours.). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that has possibly been punctured for 48 hours.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No treatment medications were reported. The patient given dose was punctured before 96 hours of administration. Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow-up received added Patient demographics, updated event outcome.

Other Meds:

Current Illness:

ID: 1678265
Sex: M
Age: 16
State: AZ

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Received the first dose of the Moderna COVID19 vaccine being 16,5 years old on march; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose of the Moderna COVID19 vaccine being 16,5 years old on march) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. In March 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose of the Moderna COVID19 vaccine being 16,5 years old on march). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose of the Moderna COVID19 vaccine being 16,5 years old on march) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information not reported.

Other Meds:

Current Illness:

ID: 1678266
Sex: F
Age: 74
State: NC

Vax Date: 08/13/2021
Onset Date: 08/24/2021
Rec V Date: 09/07/2021
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: COVID arm; Arm of injection is warm to touch; A rash appeared at the site of injection. The rash is red and a little itchy.; A rash appeared at the site of injection. The rash is red and a little itchy.; A rash appeared at the site of injection. The rash is red and a little itchy.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Arm of injection is warm to touch), VACCINATION SITE PRURITUS (A rash appeared at the site of injection. The rash is red and a little itchy.), VACCINATION SITE RASH (A rash appeared at the site of injection. The rash is red and a little itchy.) and VACCINATION SITE ERYTHEMA (A rash appeared at the site of injection. The rash is red and a little itchy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. No medical history was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Arm of injection is warm to touch), VACCINATION SITE PRURITUS (A rash appeared at the site of injection. The rash is red and a little itchy.), VACCINATION SITE RASH (A rash appeared at the site of injection. The rash is red and a little itchy.) and VACCINATION SITE ERYTHEMA (A rash appeared at the site of injection. The rash is red and a little itchy.). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) on 24-Aug-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Arm of injection is warm to touch) and VACCINATION SITE RASH (A rash appeared at the site of injection. The rash is red and a little itchy.) outcome was unknown and VACCINATION SITE PRURITUS (A rash appeared at the site of injection. The rash is red and a little itchy.) and VACCINATION SITE ERYTHEMA (A rash appeared at the site of injection. The rash is red and a little itchy.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was provided by the reporter.

Other Meds:

Current Illness:

ID: 1678267
Sex: F
Age: 65
State: SC

Vax Date: 03/10/2021
Onset Date: 04/08/2021
Rec V Date: 09/07/2021
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: Severe pain in her joint (mainly wrists, elbows and knees); Patient was very achy for about 2 and a half days; No energy; Almost like she had the flu; Received a probably expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Almost like she had the flu), EXPIRED PRODUCT ADMINISTERED (Received a probably expired vaccine), ARTHRALGIA (Severe pain in her joint (mainly wrists, elbows and knees)) and MYALGIA (Patient was very achy for about 2 and a half days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003A21A) for COVID-19 vaccination. Medical history was not provided by reporter. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), ACETYLSALICYLIC ACID (ASPIRIN 81), ROSUVASTATIN CALCIUM (CRESTOR) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Almost like she had the flu), EXPIRED PRODUCT ADMINISTERED (Received a probably expired vaccine) and MYALGIA (Patient was very achy for about 2 and a half days). On 12-Apr-2021, the patient experienced ARTHRALGIA (Severe pain in her joint (mainly wrists, elbows and knees)). The patient was treated with IBUPROFEN for Pain, at a dose of 800 mg. On 08-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Received a probably expired vaccine) had resolved. On 11-Apr-2021, ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Almost like she had the flu) and MYALGIA (Patient was very achy for about 2 and a half days) had resolved. At the time of the report, ARTHRALGIA (Severe pain in her joint (mainly wrists, elbows and knees)) outcome was unknown. Treatment also included an additional medication for pain. Labs and diagnostic testing included unspecified blood tests with unremarkable results and an assessment by a Rheumatologist, with unremarkable results.

Other Meds: PROZAC; ASPIRIN 81; CRESTOR; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1678268
Sex: F
Age: 38
State: TX

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/07/2021
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: Sudden Dry mouth; This spontaneous case was reported by a nurse and describes the occurrence of DRY MOUTH (Sudden Dry mouth) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced DRY MOUTH (Sudden Dry mouth). At the time of the report, DRY MOUTH (Sudden Dry mouth) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DRY MOUTH (Sudden Dry mouth) to be possibly related. The concomitant history was not reported. The treatment history was not provided. Patient Patient experienced sudden dry mouth after first dose, another patient also experienced the same with same vial. No incidents found of improper storage refrigeration r freezing. Two remaining vials of same lot number are set aside. Clinic utilized a different lot number 047B21A no reported symptoms of dry mouth since implementation.

Other Meds:

Current Illness:

ID: 1678269
Sex: F
Age: 0
State: MO

Vax Date: 07/15/2021
Onset Date: 08/25/2021
Rec V Date: 09/07/2021
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: Test Name: Viral load Hep B; Result Unstructured Data: High Viral load Hep B

Allergies:

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

Symptoms: Missed second shot more than 42 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second shot more than 42 days after first shot) in a 5-week-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetic and Hepatitis B. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second shot more than 42 days after first shot). On 25-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Missed second shot more than 42 days after first shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral load: high (High) High Viral load Hep B. Concomitant drug was not reported. Patient had no side effects. She did not have a ride and she missed the second dose appointment. She was thinking about getting the second shot now. Treatment medication was not reported.

Other Meds:

Current Illness: Diabetic; Hepatitis B

ID: 1678270
Sex: M
Age: 32
State: ME

Vax Date: 08/23/2021
Onset Date: 08/25/2021
Rec V Date: 09/07/2021
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: red rash going into his armpit; red patch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash going into his armpit) and RASH MACULAR (red patch) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced RASH ERYTHEMATOUS (red rash going into his armpit) and RASH MACULAR (red patch). At the time of the report, RASH ERYTHEMATOUS (red rash going into his armpit) and RASH MACULAR (red patch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment medications were reported. Symptoms: It was reported that the patient had experienced a red line which was going into his armpit.

Other Meds:

Current Illness:

ID: 1678271
Sex: M
Age: 43
State: MA

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 2nd she got fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (2nd she got fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 201B21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included LAMOTRIGINE (LAMICTAL), OXCARBAZEPINE, GABAPENTIN, QUETIAPINE, HYDROCHLOROTHIAZIDE, OMEPRAZOLE, NALTREXONE, PROBIOTICS NOS, LYSINE, VITAMIN D3, MELATONIN, NATTOKINASE, RESVERATROL, MONOLAURIN [GLYCERINE MONOLAURATE], FISH OIL, VITAMIN C [ASCORBIC ACID] and LEVETIRACETAM (LEVRA) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (2nd she got fever). At the time of the report, PYREXIA (2nd she got fever) outcome was unknown. Concomitant medications also include sertiamen and IGG infusions weekly. No treatment medication were reported. This case was linked to MOD-2021-296523, MOD-2021-296516 (Patient Link).

Other Meds: LAMICTAL; OXCARBAZEPINE; GABAPENTIN; QUETIAPINE; HYDROCHLOROTHIAZIDE; OMEPRAZOLE; NALTREXONE; PROBIOTICS NOS; LYSINE; VITAMIN D3; MELATONIN; NATTOKINASE; RESVERATROL; MONOLAURIN [GLYCERINE MONOLAURATE]; FISH OIL; VITAMIN C [ASCORBIC ACID];

Current Illness:

ID: 1678272
Sex: M
Age:
State: TX

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Too late to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Too late to get the second dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Too late to get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Too late to get the second dose) had resolved. Patient has not experienced any symptoms after the first dose. Concomitant medications include medications for type-2 diabetes mellitus and high blood pressure. Treatment information was not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am