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: 1665609
Sex: F
Age: 37
State: NY

Vax Date: 05/21/2021
Onset Date: 08/16/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Date: 20210816; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: COVID-19; Loss of taste and smell; Loss of taste and smell; Congestion; Cough here and there; Sneeze here and there; Body fatigue; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion) and COUGH (Cough here and there) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The consumer have received first dose of Moderna COVID-19 vaccine on 21 May 2021 and second dose on 21 June 2021. The consumer had tested positive for COVID-19 on 16 Aug 2021 and her symptoms are loss of taste and smell, congestion, cough here and there, sneeze here and there and body fatigue. No concomitant product use was provided by the reporter. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1665610
Sex: F
Age: 50
State: WY

Vax Date: 08/14/2021
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
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: Test Date: 20210816; Test Name: Diastolic blood pressure; Result Unstructured Data: 40; Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: blood pressure tanked so badly

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond; Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond; Still feels a little under the weather; Weak; Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond; Very tired; For the first 2 days, she was feeling lethargic and not wanting to eat or drink.; For the first 2 days, she was feeling lethargic and not wanting to eat or drink; For the first 2 days, she was feeling lethargic and not wanting to eat or drink; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), UNRESPONSIVE TO STIMULI (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond) and LETHARGY (For the first 2 days, she was feeling lethargic and not wanting to eat or drink.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, HYDRALAZINE, PRAZOSIN and ISOSORBIDE for an unknown indication. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced LETHARGY (For the first 2 days, she was feeling lethargic and not wanting to eat or drink.) (seriousness criterion medically significant), DECREASED APPETITE (For the first 2 days, she was feeling lethargic and not wanting to eat or drink), THIRST DECREASED (For the first 2 days, she was feeling lethargic and not wanting to eat or drink) and FATIGUE (Very tired). On 16-Aug-2021, the patient experienced BLINDNESS TRANSIENT (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond) (seriousness criteria hospitalization and medically significant), UNRESPONSIVE TO STIMULI (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond) (seriousness criteria hospitalization and medically significant) and DIZZINESS (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond). On an unknown date, the patient experienced ILLNESS (Still feels a little under the weather) and ASTHENIA (Weak). The patient was hospitalized on 16-Aug-2021 due to BLINDNESS TRANSIENT and UNRESPONSIVE TO STIMULI. At the time of the report, BLINDNESS TRANSIENT (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), UNRESPONSIVE TO STIMULI (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), DECREASED APPETITE (For the first 2 days, she was feeling lethargic and not wanting to eat or drink), THIRST DECREASED (For the first 2 days, she was feeling lethargic and not wanting to eat or drink), DIZZINESS (Blood pressure tanked so badly that she went blind and dizzy and she was not able to respond), ILLNESS (Still feels a little under the weather) and FATIGUE (Very tired) was resolving and LETHARGY (For the first 2 days, she was feeling lethargic and not wanting to eat or drink.) and ASTHENIA (Weak) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Blood pressure diastolic: 40 (Low) 40. On 16-Aug-2021, Blood pressure measurement: abnormal (abnormal) blood pressure tanked so badly. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No additional treatment medication was provided. On 14-Aug-2021, patient received first dose of Moderna COVID-19 vaccine in the left, non-dominant arm. For the first 2 days, she was feeling lethargic and not wanting to eat or drink and was very tired. By 16-Aug-2021, the patient's blood pressure tanked so badly that she went blind and was dizzy and was not able to respond. Her husband called an ambulance, and patient was taken to emergency room and the diastolic blood pressure was 40. The patient received fluids in ER, however they were not able to raise blood pressure hence patient was in the hospital for 2 days and 1 night. Patient was tested for everything and everything else was ruled out and they concluded that this episode was from the vaccine. Patient suffers from high blood pressure usually and no one warned about the problem the vaccine could have with blood pressure. Patient was home from the hospital and still feels a little under the weather, however overall feeling a little better and was still lethargic and weak. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.

Other Meds: METOPROLOL; HYDRALAZINE; PRAZOSIN; ISOSORBIDE

Current Illness: Blood pressure high

ID: 1665611
Sex: F
Age: 87
State: FL

Vax Date: 01/15/2021
Onset Date: 07/01/2021
Rec V Date: 09/02/2021
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: Test Name: Covid-19 test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: tested positive for Covid-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive Positive. No concomitant medication was reported. No treatment medication was reported. Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This is a case of lack of efficacy of the product.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This is a case of lack of efficacy of the product.

Other Meds:

Current Illness:

ID: 1665612
Sex: M
Age:
State: VA

Vax Date: 02/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Breathing symptoms linger; Tested positive for covid.19; Terrible symptoms; Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing symptoms linger), COVID-19 (Tested positive for covid.19), VACCINATION COMPLICATION (Terrible symptoms) and DRUG INEFFECTIVE (Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DRUG INEFFECTIVE (Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021). On an unknown date, the patient experienced DYSPNOEA (Breathing symptoms linger), COVID-19 (Tested positive for covid.19) and VACCINATION COMPLICATION (Terrible symptoms). At the time of the report, DYSPNOEA (Breathing symptoms linger) had not resolved, COVID-19 (Tested positive for covid.19) and DRUG INEFFECTIVE (Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021) outcome was unknown and VACCINATION COMPLICATION (Terrible symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. Relevant concomitant medications were not provided. Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Company Comment: Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. This is also a case of Drug ineffective (Lack of drug effect) assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). Based on the current available information and temporal association between the use of the product and the tentative start date of the occurrence of the events, Dyspnoea (Breathing symptoms linger), Vaccination complication (Terrible symptoms), a causal relationship cannot be excluded.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. This is also a case of Drug ineffective (Lack of drug effect) assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). Based on the current available information and temporal association between the use of the product and the tentative start date of the occurrence of the events, Dyspnoea (Breathing symptoms linger), Vaccination complication (Terrible symptoms), a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1665613
Sex: M
Age: 69
State: GA

Vax Date: 03/08/2021
Onset Date: 03/10/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: 80/40's; Test Name: Blood pressure; Result Unstructured Data: 190/98

Allergies:

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

Symptoms: low blood pressure (9 days) (80/40's); blood pressure went up 190/98; lungs became congested/congestion; coughing up phlegm; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lungs became congested/congestion) in a 69-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 Heart attack (had a heart attack at 62 years old) and Lyme disease. Concomitant products included CLOPIDOGREL, ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, LISINOPRIL, SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PULMONARY CONGESTION (lungs became congested/congestion) (seriousness criterion medically significant) and PRODUCTIVE COUGH (coughing up phlegm). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (low blood pressure (9 days) (80/40's)) and BLOOD PRESSURE INCREASED (blood pressure went up 190/98). At the time of the report, PULMONARY CONGESTION (lungs became congested/congestion) had not resolved and PRODUCTIVE COUGH (coughing up phlegm), BLOOD PRESSURE DECREASED (low blood pressure (9 days) (80/40's)) and BLOOD PRESSURE INCREASED (blood pressure went up 190/98) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) 80/40's and increased (High) 190/98. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication included statins drugs. Treatment was not given. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: CLOPIDOGREL; ASPIRIN [ACETYLSALICYLIC ACID]; CARVEDILOL; LISINOPRIL; PROAIR HFA; SPIRIVA

Current Illness:

ID: 1665614
Sex: F
Age: 85
State: TX

Vax Date: 01/13/2021
Onset Date: 02/10/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 02FL20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) (seriousness criterion medically significant). At the time of the report, RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) outcome was unknown. Concomitant medication included Zedia. After the second shot of vaccination, patient visited dermatologist, a family practice, and the emergency room. She had problems with a rash since. The doctor prescribed with something to put on the head for the rash so she could sleep at night. Patient had salves, lotions but nothing had helped her. 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 this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds: PLAVIX; METOPROLOL

Current Illness:

ID: 1665615
Sex: F
Age: 47
State: NJ

Vax Date: 04/14/2021
Onset Date: 04/21/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Experienced seizure episodes; Muscle weakness; Stiffness; Joint pain; Loss of motor skills, couldn't use hands, lost control of her arms, legs and muscle control; Experienced myoclonus; Her head went back and forth; Had a loss of speech / could not communicate but she could hear people talking during her episode; She went from 100% strength to 50% strength; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Experienced seizure episodes), MUSCULAR WEAKNESS (Muscle weakness), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Joint pain), ATAXIA (Loss of motor skills, couldn't use hands, lost control of her arms, legs and muscle control), MYOCLONUS (Experienced myoclonus), POSTURE ABNORMAL (Her head went back and forth), DYSARTHRIA (Had a loss of speech / could not communicate but she could hear people talking during her episode) and ASTHENIA (She went from 100% strength to 50% strength) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient tested positive but not hospitalized.) on 09-Dec-2020. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SEIZURE (Experienced seizure episodes) (seriousness criteria hospitalization and medically significant), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion hospitalization), ARTHRALGIA (Joint pain) (seriousness criterion hospitalization), ATAXIA (Loss of motor skills, couldn't use hands, lost control of her arms, legs and muscle control) (seriousness criterion hospitalization), MYOCLONUS (Experienced myoclonus) (seriousness criterion hospitalization), POSTURE ABNORMAL (Her head went back and forth) (seriousness criterion hospitalization), DYSARTHRIA (Had a loss of speech / could not communicate but she could hear people talking during her episode) (seriousness criterion hospitalization) and ASTHENIA (She went from 100% strength to 50% strength) (seriousness criterion hospitalization). The patient was hospitalized from 21-Apr-2021 to 23-Apr-2021 due to ARTHRALGIA, ASTHENIA, ATAXIA, DYSARTHRIA, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, MYOCLONUS, POSTURE ABNORMAL and SEIZURE. The patient was treated with Physical therapy for Muscular weakness. At the time of the report, SEIZURE (Experienced seizure episodes), MUSCULAR WEAKNESS (Muscle weakness), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Joint pain), ATAXIA (Loss of motor skills, couldn't use hands, lost control of her arms, legs and muscle control), MYOCLONUS (Experienced myoclonus), POSTURE ABNORMAL (Her head went back and forth), DYSARTHRIA (Had a loss of speech / could not communicate but she could hear people talking during her episode) and ASTHENIA (She went from 100% strength to 50% strength) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were reported. Treatment information was not provided. The reporter stated that the patient was not able to speak and it took time for her to speak again post the episodes. The physicians were not able to determine what was wrong with her at that time and received outpatient physical therapy treatment. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-293196 (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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1665616
Sex: F
Age: 36
State: NC

Vax Date: 01/15/2021
Onset Date: 01/29/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Name: heart ultrasound; Result Unstructured Data: Patient had amount of fluid around her heart from her heart ultrasound

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Pressure in my right eye was 34 or 35, pressure in eft eye was 28; Numbness on right side; Tingling on my right side; Vision was distorted for almost 3 weeks; Vision was blurred; was not able to drive for 3 weeks; Vertigo-type symptoms; Throw up; would get nauseated; Face was drooping back and forth, like a Bell's Palsy situation; Small amount of fluid around my heart; Lost vision in my left eye; Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital; Her doctor advised her not to receive the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital), FACIAL PARALYSIS (Face was drooping back and forth, like a Bell's Palsy situation), PERICARDIAL EFFUSION (Small amount of fluid around my heart), BLINDNESS (Lost vision in my left eye), INTRAOCULAR PRESSURE INCREASED (Pressure in my right eye was 34 or 35, pressure in eft eye was 28), HYPOAESTHESIA (Numbness on right side), PARAESTHESIA (Tingling on my right side), METAMORPHOPSIA (Vision was distorted for almost 3 weeks), VISION BLURRED (Vision was blurred), IMPAIRED DRIVING ABILITY (was not able to drive for 3 weeks), VERTIGO (Vertigo-type symptoms), VOMITING (Throw up) and NAUSEA (would get nauseated) in a 37-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. Previously administered products included for Anaphylactic reaction: TETANUS VACCINE (they determined she was allergic to something in the vaccine and not tetanus itself.). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MIGRAINE (Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital) (seriousness criterion hospitalization). On 09-Feb-2021, the patient experienced BLINDNESS (Lost vision in my left eye) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FACIAL PARALYSIS (Face was drooping back and forth, like a Bell's Palsy situation) (seriousness criteria hospitalization and medically significant), PERICARDIAL EFFUSION (Small amount of fluid around my heart) (seriousness criteria hospitalization and medically significant), INTRAOCULAR PRESSURE INCREASED (Pressure in my right eye was 34 or 35, pressure in eft eye was 28) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness on right side) (seriousness criterion hospitalization), PARAESTHESIA (Tingling on my right side) (seriousness criterion hospitalization), METAMORPHOPSIA (Vision was distorted for almost 3 weeks) (seriousness criterion hospitalization), VISION BLURRED (Vision was blurred) (seriousness criterion hospitalization), IMPAIRED DRIVING ABILITY (was not able to drive for 3 weeks) (seriousness criterion hospitalization), VERTIGO (Vertigo-type symptoms) (seriousness criterion hospitalization), VOMITING (Throw up) (seriousness criterion hospitalization), NAUSEA (would get nauseated) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Her doctor advised her not to receive the second dose). The patient was hospitalized on 09-Feb-2021 due to BLINDNESS, FACIAL PARALYSIS, HYPOAESTHESIA, IMPAIRED DRIVING ABILITY, INTRAOCULAR PRESSURE INCREASED, METAMORPHOPSIA, MIGRAINE, NAUSEA, PARAESTHESIA, PERICARDIAL EFFUSION, VERTIGO, VISION BLURRED and VOMITING. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital), FACIAL PARALYSIS (Face was drooping back and forth, like a Bell's Palsy situation), PERICARDIAL EFFUSION (Small amount of fluid around my heart), BLINDNESS (Lost vision in my left eye), INTRAOCULAR PRESSURE INCREASED (Pressure in my right eye was 34 or 35, pressure in eft eye was 28), HYPOAESTHESIA (Numbness on right side), PARAESTHESIA (Tingling on my right side), METAMORPHOPSIA (Vision was distorted for almost 3 weeks), VISION BLURRED (Vision was blurred), IMPAIRED DRIVING ABILITY (was not able to drive for 3 weeks), VERTIGO (Vertigo-type symptoms), VOMITING (Throw up) and NAUSEA (would get nauseated) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Her doctor advised her not to receive the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) Patient had amount of fluid around her heart from her heart ultrasound. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. 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: 1665617
Sex: M
Age: 68
State: GA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 09/02/2021
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: 20210813; Test Name: Covid-19 Test; Test Result: Positive ; Result Unstructured Data: Positive with Covid 19

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: EPV virus was reactivated; Chronic fatigue; Patient was infected with Covid-19 virus after the two doses of vaccine; COVID-19/Positive with Covid-19/confirmed to be infected with Covid-19 virus; Coughing; Wheezing; First dose received on 30-Dec-2021 and Second dose receievd on 04-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION REACTIVATION (EPV virus was reactivated) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L2DA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Epstein-Barr virus infection (EPV virus was reactivated) and Chronic fatigue (Having chronic fatigue for a long time already). On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 30-Dec-2021 and Second dose receievd on 04-Feb-2021). On 07-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Coughing) and WHEEZING (Wheezing). On 13-Aug-2021, the patient experienced COVID-19 (COVID-19/Positive with Covid-19/confirmed to be infected with Covid-19 virus) and DRUG INEFFECTIVE (Patient was infected with Covid-19 virus after the two doses of vaccine). On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (EPV virus was reactivated) (seriousness criterion medically significant) and FATIGUE (Chronic fatigue). On 04-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 30-Dec-2021 and Second dose receievd on 04-Feb-2021) had resolved. At the time of the report, EPSTEIN-BARR VIRUS INFECTION REACTIVATION (EPV virus was reactivated), COVID-19 (COVID-19/Positive with Covid-19/confirmed to be infected with Covid-19 virus), COUGH (Coughing), WHEEZING (Wheezing) and DRUG INEFFECTIVE (Patient was infected with Covid-19 virus after the two doses of vaccine) outcome was unknown and FATIGUE (Chronic fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: inconclusive (Positive) Positive with Covid 19. No Concomitant product use was reported. No treatment information was provided. It was reported that last 04-Aug-2021, patient went to a hospital and undergone esophageal dilation. Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: Additional information received on 23-Aug-2021 and included Patient gender was updated to male from previously reported Female.; Sender's Comments: This is a case of Drug ineffective and Inappropriate schedule of vaccine administered with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Chronic fatigue (Having chronic fatigue for a long time already); Epstein-Barr virus infection (EPV virus was reactivated)

ID: 1665618
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Screening test; Result Unstructured Data: showed a possible tumor.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Has a gaping wound, sutures not healing, wound is weeping and bleeding; Non-healing wound from a non-invasive surgery after moderna dose; Wound is weeping and bleeding; Wound is weeping and bleeding; This spontaneous case was reported by a consumer and describes the occurrence of POSTOPERATIVE WOUND INFECTION (Has a gaping wound, sutures not healing, wound is weeping and bleeding) in a 66-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 Lung cancer, Tumor, Hospitalization, Lung neoplasm surgery (The patient had a non-invasive surgery 5 years ago to remove a possible cancerous mass in the lung.) and Lung neoplasm surgery on 20-Apr-2021. Concurrent medical conditions included Smoker and Hypertension. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced IMPAIRED HEALING (Non-healing wound from a non-invasive surgery after moderna dose), WOUND SECRETION (Wound is weeping and bleeding) and WOUND HAEMORRHAGE (Wound is weeping and bleeding). In August 2021, the patient experienced POSTOPERATIVE WOUND INFECTION (Has a gaping wound, sutures not healing, wound is weeping and bleeding) (seriousness criterion medically significant). At the time of the report, POSTOPERATIVE WOUND INFECTION (Has a gaping wound, sutures not healing, wound is weeping and bleeding), IMPAIRED HEALING (Non-healing wound from a non-invasive surgery after moderna dose), WOUND SECRETION (Wound is weeping and bleeding) and WOUND HAEMORRHAGE (Wound is weeping and bleeding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Investigation: abnormal (abnormal) showed a possible tumor.. The reporter stated that the patient had a non-invasive surgery 5 years ago to remove a possible cancerous mass in his lung. The patient recovered fully, spent only a minimal time in the hospital for his lung to recover. on 20 Apr 2021, the patient underwent the same non-invasive surgery, which he underwent before. During the time of call, the patient still has not recovered, still has a gaping wound, sutures not healing, wound is weeping and bleeding. The reporter stated that the patient's dead tissue from the incision was also removed. The patient consulted the doctor several times already. The patient was prescribed two rounds of 10-day antibiotics. The patient's symptoms seems to get better during the course of antibiotics but when it ends, the symptoms eventually returns. No concomitant product use was provided by the reporter. Based on the very limited 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 very limited 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: Hypertension; Smoker

ID: 1665619
Sex: M
Age:
State: CT

Vax Date: 08/12/2021
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210814; Test Name: CRP; Result Unstructured Data: CRP 4.6 mg/dL; Test Date: 20210816; Test Name: TRANSTHORACIC ECHOCARDIOGRAM; Result Unstructured Data: Normal left ventricular ejection fraction estimated at 55-65%. Simpson's biplane EF is 59%.; Test Date: 20210815; Test Name: ESR; Result Unstructured Data: ESR 621 U/L; Test Date: 20210815; Test Name: Troponin; Test Result: Positive ; Result Unstructured Data: Troponin 6743 ng/L; Test Date: 20210816; Test Name: Troponin; Test Result: Positive ; Result Unstructured Data: Troponin 3247 ng/L

Allergies:

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

Symptoms: Left arm soreness; Shortness of breath; Nausea; vomiting; Chills; Chest Pain; chest discomfort/Chest Pressure; Fever chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (chest discomfort/Chest Pressure), PYREXIA (Fever chills), CHILLS (Chills), PAIN IN EXTREMITY (Left arm soreness), DYSPNOEA (Shortness of breath), NAUSEA (Nausea) and VOMITING (vomiting) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Family history included Heart disease, unspecified (Patient's symptoms did not suggest an ischemic syndrome per cardiology notes). Concurrent medical conditions included Asthma. On 12-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On 15-Aug-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness) (seriousness criterion hospitalization). In August 2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (chest discomfort/Chest Pressure) (seriousness criterion hospitalization) and PYREXIA (Fever chills) (seriousness criterion hospitalization). The patient was hospitalized from 15-Aug-2021 to 16-Aug-2021 due to CHEST DISCOMFORT, CHEST PAIN, CHILLS, DYSPNOEA, NAUSEA, PAIN IN EXTREMITY, PYREXIA and VOMITING. The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 mg every eight hours; NITROGLYCERIN for Chest pain, at a dose of UNK unit and KETOROLAC TROMETHAMINE (TORADOL) (intramuscular) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (chest discomfort/Chest Pressure), PYREXIA (Fever chills), CHILLS (Chills), PAIN IN EXTREMITY (Left arm soreness), DYSPNOEA (Shortness of breath), NAUSEA (Nausea) and VOMITING (vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, C-reactive protein increased: 4.6 (High) CRP 4.6 mg/dL. On 15-Aug-2021, Red blood cell sedimentation rate increased: 621 (High) ESR 621 U/L. On 15-Aug-2021, Troponin: 6743 (Positive) Troponin 6743 ng/L. On 16-Aug-2021, Echocardiogram: normal (normal) Normal left ventricular ejection fraction estimated at 55-65%. Simpson's biplane EF is 59%.. On 16-Aug-2021, Troponin: 3247 (Positive) Troponin 3247 ng/L. On an unknown date, COVID-19: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter Patient reported that after receiving 2nd dose he experienced fever, chills and sharp chest pain in the mid of the left chest area. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-293731 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Asthma

ID: 1665620
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid) 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 26-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid) 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 provided. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1665621
Sex: F
Age: 77
State: GA

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

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

Lab Data:

Allergies:

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

Symptoms: skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes; It burns/on the sides of the mouth and the lips they just burns; Dry skin; I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been; it's dry, on the sides of the mouth and the lips; Itchy; Redness/It's all over my neck. It just everywhere"; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been) and LIP DRY (it's dry, on the sides of the mouth and the lips) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013421A and 012A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (COVID-19 positive and was hospitalized 8 days) in August 2020 and Lumpectomy. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been), LIP DRY (it's dry, on the sides of the mouth and the lips), PRURITUS (Itchy) and ERYTHEMA (Redness/It's all over my neck. It just everywhere"). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK, qid 7 days. At the time of the report, SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been), LIP DRY (it's dry, on the sides of the mouth and the lips), PRURITUS (Itchy) and ERYTHEMA (Redness/It's all over my neck. It just everywhere") had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Laboratory details: Biopsy done but results were not provided

Other Meds:

Current Illness:

ID: 1665622
Sex: M
Age: 83
State: ME

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: COVID-19; Drug ineffective; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DULAGLUTIDE (TRULICITY), Regular insulin, ISOPHANE INSULIN (NPH INSULIN) and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication. On 17-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 COVID-19 (COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment product was not provided by the reporter This is a case of Drug ineffective, lack of efficacy, with both doses given and COVID-19 diagnosed several months later. Based on current available information and the temporal association between product and the start date of the COVID-19 diagnosis a causal relationship is possible for the event of Drug ineffective. This case was linked to MOD-2021-294145 (Patient Link).; Sender's Comments: This is a case of Drug ineffective, lack of efficacy, with both doses given and COVID-19 diagnosed several months later. Based on current available information and the temporal association between product and the start date of the COVID-19 diagnosis a causal relationship is possible for the event of Drug ineffective.

Other Meds: TRULICITY; Regular insulin; NPH INSULIN; NITROGLYCERIN

Current Illness:

ID: 1665623
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 07/01/2021
Rec V Date: 09/02/2021
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: Test Name: Platelet count; Result Unstructured Data: Normal; Test Date: 202107; Test Name: Platelet count; Result Unstructured Data: High

Allergies:

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

Symptoms: Developed COVID-19; Elevated platelet counts (300 to 530); Trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)) and COVID-19 (Developed COVID-19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1232366) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication. Concurrent medical conditions included Dry skin. Concomitant products included OMEPRAZOLE, DIAZEPAM and HYDROXYZINE for an unknown indication. In June 2021, the patient RUXOLITINIB PHOSPHATE (JAKAFI) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram once a day. In July 2021, the patient experienced PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)) (seriousness criterion hospitalization). On 18-Jul-2021, the patient experienced COVID-19 (Developed COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping). The patient was hospitalized on sometime in July 2021 due to PLATELET COUNT INCREASED. At the time of the report, PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)), COVID-19 (Developed COVID-19) and INSOMNIA (Trouble sleeping) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Platelet count: 530 (High) High. On an unknown date, Platelet count: 300 (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient visited the emergency room 3 time due to elevated platelet count. 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 events, a causal relationship cannot be excluded. Concomitant medication RUXOLITINIB was considered as cosuspect. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medication RUXOLITINIB was considered as cosuspect. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.

Other Meds: OMEPRAZOLE; DIAZEPAM; HYDROXYZINE

Current Illness: Dry skin

ID: 1665624
Sex: F
Age: 76
State: CT

Vax Date: 01/29/2021
Onset Date: 08/19/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: High

Allergies:

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

Symptoms: Feels exhausted,Tired; Very bad joint pain; Dry blood in each nostril; High temperature of 100.9 degrees; Nausea; Feeling dizzy; Vomiting; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Dry blood in each nostril), PYREXIA (High temperature of 100.9 degrees), NAUSEA (Nausea), DIZZINESS (Feeling dizzy), VOMITING (Vomiting), FATIGUE (Feels exhausted,Tired) and ARTHRALGIA (Very bad joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A, 012L20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Lupus erythematosus and Joint pain. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 21-Aug-2021, the patient experienced EPISTAXIS (Dry blood in each nostril) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PYREXIA (High temperature of 100.9 degrees) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization), DIZZINESS (Feeling dizzy) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), FATIGUE (Feels exhausted,Tired) (seriousness criterion hospitalization) and ARTHRALGIA (Very bad joint pain) (seriousness criterion hospitalization). The patient was hospitalized for 2 days until 21-Aug-2021 due to DIZZINESS, NAUSEA and VOMITING, and then for 2 days due to PYREXIA. On 19-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, EPISTAXIS (Dry blood in each nostril), PYREXIA (High temperature of 100.9 degrees), NAUSEA (Nausea), DIZZINESS (Feeling dizzy), VOMITING (Vomiting), FATIGUE (Feels exhausted,Tired) and ARTHRALGIA (Very bad joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degree (High) High. No treatment information was provided. It was reported that patient had history of autoimmune disorder of Lupus with positive ANA that was diagnosed with prior to receiving the vaccine a few years. It was reported that patient's was back and had something to eat. 1st dose received on: 29Jan2021, left arm, IM injection, Lot: 012L20A, Expiration: Unknown 2nd dose received on:26Feb2021, left arm, IM injection, Lot: 003A21A, Expiration: Unknown Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, medical history of Lupus with positive ANA (LLT: Lupus erythematosus) and joint pain (LLT Joint pain) could be confounding factors for the case.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, medical history of Lupus with positive ANA (LLT: Lupus erythematosus) and joint pain (LLT Joint pain) could be confounding factors for the case.

Other Meds: TYLENOL

Current Illness:

ID: 1665625
Sex: F
Age: 86
State: FL

Vax Date: 02/12/2021
Onset Date: 05/01/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: bacterial pneumonia; felt a little ill; felt tired the next day; had a sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA BACTERIAL (bacterial pneumonia) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PNEUMONIA BACTERIAL (bacterial pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt a little ill), FATIGUE (felt tired the next day) and VACCINATION SITE PAIN (had a sore arm for a day). The patient was hospitalized from sometime in May 2021 to sometime in May 2021 due to PNEUMONIA BACTERIAL. At the time of the report, PNEUMONIA BACTERIAL (bacterial pneumonia), VACCINATION COMPLICATION (felt a little ill) and FATIGUE (felt tired the next day) outcome was unknown and VACCINATION SITE PAIN (had a sore arm for a day) had resolved. No relevant concomitant medications were reported. No treatment information was provided. Patient was hospitalized for 4.5 days around the end of May for bacterial pneumonia with no other side effects or symptoms. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected due to decline on follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected due to decline on follow up.

Other Meds:

Current Illness:

ID: 1665626
Sex: F
Age: 67
State: MI

Vax Date: 02/26/2021
Onset Date: 03/03/2021
Rec V Date: 09/02/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Name: Blood test; Result Unstructured Data: Consumer stated her A1C stays below7.; Test Name: MRI; Result Unstructured Data: Consumer was scheduled for MRI to rule out for brain tumor. Consumer was diagnosed with sixth nerve eye palsy

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Sixth nerve eye palsy; Double vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VITH NERVE PARALYSIS (Sixth nerve eye palsy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. The patient's past medical history included Cataract operation (Consumer had a cataract surgery about 6 years ago.) in 2015. Concurrent medical conditions included Diabetes and Blood pressure. 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) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VITH NERVE PARALYSIS (Sixth nerve eye palsy) (seriousness criterion medically significant) and DIPLOPIA (Double vision). At the time of the report, VITH NERVE PARALYSIS (Sixth nerve eye palsy) and DIPLOPIA (Double vision) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Consumer stated her A1C stays below7.. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Consumer was scheduled for MRI to rule out for brain tumor. Consumer was diagnosed with sixth nerve eye palsy. Consumer was call to report possible adverse events and with a MI inquiry. Consumer stated she experienced adverse event after 1st dose of the vaccine but still got her 2nd dose. Consumer stated her adverse event is still ongoing and has not subsided. On 03Mar2021 consumer experienced double vision while driving. Consumer contacted her HCP who scheduled MRI and additional eyes tests. Consumer's HCP suggested that the condition may be caused by diabetes and give it time to selfheal. Consumer stated that she was healthy prior to vaccination. Consumer was not prescribed medication(s) for the condition. Consumer does not take any medicaion except for blood pressure and diabetes. Treatment information was not provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's med hx of HTN and DM are confounding factors that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's med hx of HTN and DM are confounding factors that may play a possible contributory role.

Other Meds:

Current Illness: Blood pressure; Diabetes

ID: 1665627
Sex: F
Age: 59
State: OH

Vax Date: 02/17/2021
Onset Date: 05/01/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Name: TSH; Result Unstructured Data: not detectable; Test Name: T4; Result Unstructured Data: Her free T4 is 2.44

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: developed hyperthyroidism; lost 62-63lb in 2 months; she can't swallow; Gallbladder turned green and disintegrated; Gallbladder turned green and disintegrated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (developed hyperthyroidism), WEIGHT DECREASED (lost 62-63lb in 2 months), DYSPHAGIA (she can't swallow), GALLBLADDER DISORDER (Gallbladder turned green and disintegrated) and GALLBLADDER RUPTURE (Gallbladder turned green and disintegrated) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Gallbladder removal (was hospitalized for 6 days). Concurrent medical conditions included Asthma (had been on same medications for severe asthma for last 5 years, did not provide medication list). On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced GALLBLADDER DISORDER (Gallbladder turned green and disintegrated) (seriousness criterion hospitalization) and GALLBLADDER RUPTURE (Gallbladder turned green and disintegrated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERTHYROIDISM (developed hyperthyroidism) (seriousness criteria hospitalization and medically significant), WEIGHT DECREASED (lost 62-63lb in 2 months) (seriousness criterion hospitalization) and DYSPHAGIA (she can't swallow) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to GALLBLADDER DISORDER. The patient was treated with Surgery (surgery to remove the gallbladder and was hospitalized for 6 days) for Gallbladder disorder. At the time of the report, HYPERTHYROIDISM (developed hyperthyroidism), WEIGHT DECREASED (lost 62-63lb in 2 months), DYSPHAGIA (she can't swallow), GALLBLADDER DISORDER (Gallbladder turned green and disintegrated) and GALLBLADDER RUPTURE (Gallbladder turned green and disintegrated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: not detectable not detectable. On an unknown date, Thyroxine: 2.44 (Low) Her free T4 is 2.44. Concomitant medication taken by the patient include medications for Asthma. About two months after the second shot her gallbladder turned green and disintegrated upon removal. Around the same time, she developed hyperthyroidism and lost 62 to 63lb in two months. She said her thyroid stimulating hormone was not detectable and her free T4 was 2.44. 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: Asthma (had been on same medications for severe asthma for last 5 years, did not provide medication list)

ID: 1665628
Sex: F
Age: 44
State: NC

Vax Date: 08/14/2021
Onset Date: 08/15/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had an allergic reaction to Moderna Covid-19 vaccine; Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears; Broke out in rash on her injection site right arm.; Broke out in Hives on her injection site right arm.; Achy; Tired; Swollen lymph nodes in my right arm pit; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in Hives on her injection site right arm.), ALLERGY TO VACCINE (Had an allergic reaction to Moderna Covid-19 vaccine), URTICARIA (Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears), VACCINATION SITE PAIN (Sore right injection site arm) and VACCINATION SITE RASH (Broke out in rash on her injection site right arm.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). On 18-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in my right arm pit). On 19-Aug-2021, the patient experienced MYALGIA (Achy) and FATIGUE (Tired). On 20-Aug-2021, the patient experienced URTICARIA (Broke out in Hives on her injection site right arm.) and VACCINATION SITE RASH (Broke out in rash on her injection site right arm.). On 24-Aug-2021, the patient experienced URTICARIA (Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears). On an unknown date, the patient experienced ALLERGY TO VACCINE (Had an allergic reaction to Moderna Covid-19 vaccine). On 20-Aug-2021, MYALGIA (Achy) and FATIGUE (Tired) had resolved. At the time of the report, URTICARIA (Broke out in Hives on her injection site right arm.), ALLERGY TO VACCINE (Had an allergic reaction to Moderna Covid-19 vaccine), URTICARIA (Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears), VACCINATION SITE PAIN (Sore right injection site arm), VACCINATION SITE RASH (Broke out in rash on her injection site right arm.) and LYMPHADENOPATHY (Swollen lymph nodes in my right arm pit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment medication not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint for the events.

Other Meds:

Current Illness:

ID: 1665629
Sex: F
Age:
State: MI

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 09/02/2021
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: sixth nerve palsy to the face; face was paralyzed / drooping face; Intentional dose omission; This spontaneous case was reported by a consumer and describes the occurrence of VITH NERVE PARALYSIS (sixth nerve palsy to the face) and FACIAL PARALYSIS (face was paralyzed / drooping face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 VITH NERVE PARALYSIS (sixth nerve palsy to the face) (seriousness criterion medically significant), FACIAL PARALYSIS (face was paralyzed / drooping face) (seriousness criterion medically significant) and INTENTIONAL DOSE OMISSION (Intentional dose omission). At the time of the report, VITH NERVE PARALYSIS (sixth nerve palsy to the face), FACIAL PARALYSIS (face was paralyzed / drooping face) and INTENTIONAL DOSE OMISSION (Intentional dose omission) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. It was reported that few days after the vaccination subject experienced sixth nerve palsy on face, her face was paralyzed and face was drooping down, Subject chosen not to get the second dose No Concomitant medicines were provided No Treatment medicines were provided. company comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1665630
Sex: M
Age: 81
State: TX

Vax Date: 01/04/2021
Onset Date:
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: everything seems fine; Test Name: Ultrasound; Result Unstructured Data: normal

Allergies:

Symptom List: Unevaluable event

Symptoms: a lot of physical problem; intestines are going crazy; gained 15 pounds in weight/gained in 15 pound; he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand; It was sore and scaly and irritable; lost a lot of muscles; oozing; It was sore and scaly and irritable; experienced severe water retention; my bowels are a mess; my skin is burning; I had sores on my knuckles; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (a lot of physical problem), ABDOMINAL DISCOMFORT (intestines are going crazy), WEIGHT INCREASED (gained 15 pounds in weight/gained in 15 pound), RASH ERYTHEMATOUS (he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand) and SKIN IRRITATION (It was sore and scaly and irritable) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (a lot of physical problem), ABDOMINAL DISCOMFORT (intestines are going crazy), WEIGHT INCREASED (gained 15 pounds in weight/gained in 15 pound), RASH ERYTHEMATOUS (he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand), SKIN IRRITATION (It was sore and scaly and irritable), MUSCLE ATROPHY (lost a lot of muscles), SKIN WEEPING (oozing), SKIN EXFOLIATION (It was sore and scaly and irritable), FLUID RETENTION (experienced severe water retention), ABDOMINAL DISCOMFORT (my bowels are a mess), SKIN BURNING SENSATION (my skin is burning) and MYALGIA (I had sores on my knuckles). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (a lot of physical problem), ABDOMINAL DISCOMFORT (intestines are going crazy), WEIGHT INCREASED (gained 15 pounds in weight/gained in 15 pound), RASH ERYTHEMATOUS (he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand), SKIN IRRITATION (It was sore and scaly and irritable), MUSCLE ATROPHY (lost a lot of muscles), SKIN WEEPING (oozing), SKIN EXFOLIATION (It was sore and scaly and irritable), FLUID RETENTION (experienced severe water retention), ABDOMINAL DISCOMFORT (my bowels are a mess), SKIN BURNING SENSATION (my skin is burning) and MYALGIA (I had sores on my knuckles) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: everything seems fine (normal) everything seems fine. On an unknown date, Ultrasound scan: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication included Diuretics (unspecified). After the second dose, the patient woke up with face and ears looking like had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable. The patient used a cream to use (he does not remember the name), it gets better and then it comes back, like he got sun burnt again, it can't seem to heal up. The cream makes it better, but it doesn't clear it up. He lost a lot of muscles. After the second Moderna COVID-19 injection I gained 15 pounds, experienced severe water retention," my bowels are a mess", my skin is burning. I had sores on my knuckles. The patient was given a steroid shot because in his knuckles and hand, he had huge sores, that was oozing, and the steroid shot helped. The patient had done some blood work (unspecified) and everything seems fine. 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 events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: follow-up received contains no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1665631
Sex: F
Age: 74
State: WA

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 09/02/2021
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: blacked out/lost consciousness; started shaking and couldn't hit the keys; felt sick like she had the flu; felt sick like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out/lost consciousness), TREMOR (started shaking and couldn't hit the keys), MALAISE (felt sick like she had the flu) and INFLUENZA (felt sick like she had the flu) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out/lost consciousness) (seriousness criterion medically significant), TREMOR (started shaking and couldn't hit the keys) (seriousness criterion medically significant), MALAISE (felt sick like she had the flu) (seriousness criterion medically significant) and INFLUENZA (felt sick like she had the flu) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out/lost consciousness), TREMOR (started shaking and couldn't hit the keys), MALAISE (felt sick like she had the flu) and INFLUENZA (felt sick like she had the flu) outcome was unknown. No concomitant product information were provided by the reporter. No treatment information was provided by the reporter. Company Comment: This case concerns a 75-year-old female with serious unexpected events of loss of consciousness, tremor, malaise, and influenza. Event latency within hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-295447 (Patient Link).; Sender's Comments: This case concerns a 75-year-old female with serious unexpected events of loss of consciousness, tremor, malaise, and influenza. Event latency within hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died:

ID: 1665632
Sex: M
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: died; Dermatosis; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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 DEATH (died) (seriousness criteria death and medically significant) and DERMATOSIS (Dermatosis). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DERMATOSIS (Dermatosis) outcome was unknown. Concomitant medication and treatment drug were not reported. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1665633
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Covid-19; Result Unstructured Data: Negative

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: a month ago got a breakthrough COVID-19 infection; Lack of efficacy; 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 COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative. 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 informations were reported. No Treatment informations were reported.; Sender's Comments: This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between this event is assessed as not applicable. Causality for the event drug ineffective is assessed as possible. Further information has been requested.

Other Meds:

Current Illness:

ID: 1665634
Sex: M
Age:
State: FL

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

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

Lab Data: Test Name: Phospholipid Ab IgM; Test Result: Positive ; Result Unstructured Data: antiphospholipid IgM antibodies were weakly positive; Test Name: StaClot LA; Test Result: Positive ; Result Unstructured Data: The StaClot LA assay was borderline positive, suggesting the possible presence of LA.; Test Name: Blood count; Result Unstructured Data: normal; Test Name: Blood pressure; Result Unstructured Data: Normal; Test Name: blood urea nitrogen; Test Result: Inconclusive ; Result Unstructured Data: 17; Test Name: Body temperature; Result Unstructured Data: the patient's vital signs were normal with a temperature of 36.8 degrees Celsius; Test Name: CT scan; Test Result: Inconclusive ; Result Unstructured Data: CT scan of the abdomen and pelvis without contrast demonstrated no acute intraabdominal process, including no evidence of recurrent RCC.; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: elevated; Test Name: D-dimer; Result Unstructured Data: 3840; Test Name: glomerular filtration; Test Result: Inconclusive ; Result Unstructured Data: 77; Test Name: Pulse rate; Result Unstructured Data: Normal; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: The patients international normalized ratio (INR) were mildly prolonged and corrected when mixed 50:50 with normal pooled plasma, consistent with a possible factor deficiency; Test Name: oxygen saturation; Result Unstructured Data: 97 on room air; Test Name: Dilute PT; Result Unstructured Data: 1:50 ratio; Test Name: Dilute PT; Result Unstructured Data: 1:500 ratio; Test Name: PT; Test Result: Inconclusive ; Result Unstructured Data: The patients prothrombin time (PT) were mildly prolonged and corrected when mixed 50:50 with normal pooled plasma, consistent with a possible factor deficiency; Test Name: Respiratory rate; Result Unstructured Data: Normal; Test Name: SARS-CoV-2 Spike Ab; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 spike antibodies were strongly positive, consistent with robust vaccine-induced immunity but no history of COVID-19.; Test Name: WBC; Test Result: Inconclusive ; Result Unstructured Data: 9.2 ? 109; Test Name: PE-protocol CT ANGIOGRAM of the chest; Result Unstructured Data: extensive multifocal pulmonary emboli involving both right and left lower lobe pulmonary arteries with evidence of right ventricular strain

Allergies:

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

Symptoms: Acute Pulmonary Embolism; Fevers; chills; arthralgias; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Acute Pulmonary Embolism) in a 66-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. LITERATURE REFERENCE: Concurrent medical conditions included Hypertension, Hyperlipidemia and Renal cell carcinoma. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Acute Pulmonary Embolism) (seriousness criteria hospitalization prolonged and medically significant), PYREXIA (Fevers), CHILLS (chills) and ARTHRALGIA (arthralgias). The patient was treated with APIXABAN for Drug therapy, at an unspecified dose and frequency and ENOXAPARIN (subcutaneous) for Anticoagulant therapy, at a dose of 1 mg/kg. At the time of the report, PULMONARY EMBOLISM (Acute Pulmonary Embolism), PYREXIA (Fevers), CHILLS (chills) and ARTHRALGIA (arthralgias) outcome was unknown. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: abnormal (abnormal) extensive multifocal pulmonary emboli involving both right and left lower lobe pulmonary arteries with evidence of right ventricular strain. On an unknown date, Antiphospholipid antibodies: 27.1 mpl (Positive) antiphospholipid IgM antibodies were weakly positive and 10.7 s (Positive) The StaClot LA assay was borderline positive, suggesting the possible presence of LA.. On an unknown date, Blood count: normal (normal) normal. On an unknown date, Blood pressure measurement: 138/84 mmhg (normal) Normal. On an unknown date, Blood urea: 17 mg/dl (Inconclusive) 17. On an unknown date, Body temperature: 36.8 degrees celsius (normal) the patient's vital signs were normal with a temperature of 36.8 degrees Celsius. On an unknown date, C-reactive protein: 38.2 mg/l (Inconclusive) elevated. On an unknown date, Computerised tomogram: (Inconclusive) CT scan of the abdomen and pelvis without contrast demonstrated no acute intraabdominal process, including no evidence of recurrent RCC.. On an unknown date, Fibrin D dimer: 3840ng/ml feu (abnormal) 3840. On an unknown date, Glomerular filtration rate: 77 ml/min/bsa (Inconclusive) 77. On an unknown date, Heart rate: 65 (normal) Normal. On an unknown date, International normalised ratio: 1.2 (Inconclusive) The patients international normalized ratio (INR) were mildly prolonged and corrected when mixed 50:50 with normal pooled plasma, consistent with a possible factor deficiency. On an unknown date, Oxygen saturation: 97% (normal) 97 on room air. On an unknown date, Prothrombin time: 1.7 (abnormal) 1:50 ratio, 1.7 (abnormal) 1:500 ratio and 14.0 s (Inconclusive) The patients prothrombin time (PT) were mildly prolonged and corrected when mixed 50:50 with normal pooled plasma, consistent with a possible factor deficiency. On an unknown date, Respiratory rate: 17 (normal) Normal. On an unknown date, SARS-CoV-2 antibody test: >2500 u/ml (Positive) SARS-CoV-2 spike antibodies were strongly positive, consistent with robust vaccine-induced immunity but no history of COVID-19.. On an unknown date, White blood cell count: 9.2 ? 109/l (Inconclusive) 9.2 ? 109. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PULMONARY EMBOLISM (Acute Pulmonary Embolism), PYREXIA (Fevers), CHILLS (chills) and ARTHRALGIA (arthralgias) to be possibly related. Concomitant medications were not provided by the reporter. Patient was in his usual state of health until he received his second dose of the Moderna SARS-CoV-2 vaccine dose 10 days prior. 24 hours after the immunization he experienced fevers, chills, and arthralgias that transitioned to progressive right-sided flank pain and pleuritic chest pain. The patient was transitioned to apixaban for anticoagulation and discharged instable condition with hematology follow up. Treatment information was not provided for fever, chills and arthralgia. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received by safety 27-Aug-2021 included an Email with FTA received from SARA team and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Hyperlipidemia; Hypertension; Renal cell carcinoma

ID: 1665635
Sex: F
Age:
State:

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 09/02/2021
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: I was sick for 3 months/ sick; Dizzy; blurred vision; double vision; I could not walk; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick for 3 months/ sick), DIZZINESS (Dizzy), VISION BLURRED (blurred vision), DIPLOPIA (double vision) and GAIT DISTURBANCE (I could not walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No reported medical history. Concomitant products included Aspirin for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (I was sick for 3 months/ sick), DIZZINESS (Dizzy), VISION BLURRED (blurred vision), DIPLOPIA (double vision) and GAIT DISTURBANCE (I could not walk). At the time of the report, ILLNESS (I was sick for 3 months/ sick), DIZZINESS (Dizzy), VISION BLURRED (blurred vision), DIPLOPIA (double vision) and GAIT DISTURBANCE (I could not walk) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No treatment information was provided. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

Other Meds: Aspirin

Current Illness:

ID: 1665636
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Heart inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Heart inflammation) in a 61-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Heart inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Heart inflammation) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Treatment information was not provided. Company Comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.

Other Meds:

Current Illness:

ID: 1665637
Sex: F
Age:
State: WA

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 09/02/2021
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 Date: 20210729; Test Name: ECG 12 LEAD; Result Unstructured Data: Test Result:Normal; Test Date: 20210729; Test Name: Hemoglobin a/c; Result Unstructured Data: Test Result:Normal; Test Date: 20210729; Test Name: Troponin T; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: short of breathing; was diagnosed as Vestibular Neuronitis; chest pain; ring in left ear; right face hot to touch; almost fainted; painful sore throat; canker sore on tongue; body ache; felt dizzy; fast pulse; off balance sensation; blurry vision; headache; hot flash; burning eyes; High fever at night with chills; ear pain; cold sores; chills; scalp twitching; abdominal pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in arm left on 07Jul2021 15:00 (Batch/Lot Number: EW0191) (at age 50-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 16Jun2021 15:00 (lot number: EW0167), intramuscular on the right arm at age 50-years-old). Medical history included acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included potassium bicarbonate, sodium alginate (GAVISCON ADVANCED) taken for gastrooesophageal reflux disease from Mar2021 and ongoing. Patient previously took SHINGRIX on 22May2021. The patient felt dizzy 10 minutes right after the shot, but managed to drive home. She had high fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash on 07Jul2021. Her fever didn't go away until 12Jul201 evening, chills were gone but all other symptoms stay. Since 08Jul2021, patient also developed painful sore throat and canker sore on tongue. Dizziness was constant since day 1 (07Jul2021) and took 1 Meclizine on 09Jul2021 and 11Jul2021. On 14Jul2021, there was sudden increased dizziness, scalp twitching/headache, ring in left ear and sharp ear pain from right ear, right face hot to touch, and she almost fainted. Patient took Meclizine and Ibuprofen (200mg) which helped a little. Patient saw internal doctor on 15Jul2021 and was diagnosed as Vestibular Neuronitis. She was instructed to take Ibuprofen 400-800mg 3 times a day for 1 week. If it gets worse, she need steroids. Patient plans to see ENT later. Until on 18Jul2021, patient still have constant dizziness, headache with scalp twitching, ear pain and painful canker sore. On 20Aug2021, patient reported dizziness, off balance sensation, fast pulse, blurry vision on 07Jul2021 15:10. Patient also experienced headache, hot flash, burning eyes, high fever, chills, body ache, cold sores, sharp ear pain, scalp twitching on 07Jul2021. On 14Jul2021, patient experienced chest pain and on 28Jul2021 short of breath. Events resulted in physician's office visit on 15Jul2021. Events vestibular neuritis, tinnitus resulted to 1 ENT & 2 primary care visits. The patient underwent lab tests and procedures which included EGG 12 LEAD: normal on 29Jul2021, haemoglobin: normal on 29Jul2021, and troponin t: normal on 29Jul2021. Events hot flash, burning eyes, high fever, chills, body ache, sharp ear pain was recovered with sequel on 01Aug2021. Vestibular neuritis, tinnitus, chest pain and short of breath was recovering. Outcome of the remaining events was not recovered. Events dizzy, fast pulse, off balance sensation, blurry vision, headache, hot flash, burning eyes, fever, body ache, ear pain, ring in ear, canker sore on tongue, cold sores, chills, scalp twitching, vestibular neuronitis , chest pain and short of breathing were considered important medical event by the reporter. Patient was not diagnosed with covid prior to vaccination and had not been tested post-vaccination.

Other Meds: GAVISCON ADVANCED

Current Illness:

ID: 1665638
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: started getting sick; she had pain before on her leg but with the first shot it intensified; she had pain before on her leg but with the first shot it intensified/Pain; back pain; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included ongoing pain in extremity (she had pain before on her leg but with the first shot it intensified). The patient's concomitant medications were not reported. The patient experienced started getting sick , she had pain before on her leg but with the first shot it intensified, she had pain before on her leg but with the first shot it intensified/pain, back pain on an unspecified date. it was reported during report 1 about herself this caller reported information about her sister who she reported also had the Pfizer shot. Caller mentioned that her sister had the Pfizer Shot and had side effects. She would have to ask her sister who started getting sick but that was to be expected and then got better the next day. She was the only one except for this one sister who she thinks was having a side effect. Caller was the only one having side effects within she would say 2 weeks. Her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she was still having the front. So then when she got the second shot she told the nurse her pain had increased and she said now it was getting pretty, she was been putting ice and stuff like that she got her shots really early, this was like months later. The outcome for all events was recovering. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness: Pain in leg (she had pain before on her leg but with the first shot it intensified.)

ID: 1665639
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: she got the second shot she told the nurse her pain has increased; This is a spontaneous report from a contactable consumer. This consumer reported for a female pa-tient (sister) that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspeci-fied route of administration on an unspecified date as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included, back pain from an unknown date and unknown if ongoing. It was reported that her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she's still having the front. The patient's concomitant medications were not re-ported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. Post dose 1 she started having a pain. It was reported that, the patient got the second shot she told the nurse her pain has increased on an unspecified date. Reporter stated she was calling regarding the Pfizer shot, the first one, the Covid 19 vaccine. During report 1 about herself this reporter reported information about her sister who she reported also had the Pfizer shot. Reporter mentioned that her sister had the Pfizer Shot and had side effects. She would have to ask her sister who started getting sick but that was to be expected and then got better the next day. She was the only one except for this one sister who she thought was having a side effect. Reporter was the only one having side effects within she would say 2 weeks. Her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she was still having the front. So then when she got the second shot she told the nurse her pain has increased and she said now it was getting pretty, she had been putting ice and stuff like that she got her shots really early, this was like months later. Therapeutic measures were taken as a result of the event. Outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1665640
Sex: F
Age:
State:

Vax Date: 07/19/2021
Onset Date:
Rec V Date: 09/02/2021
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: stomach cramps; nausea; vomiting; diarrhea; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection), via an unspecified route of administration on 19Jul2021 10:30 (Batch/Lot Number: ew0217) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Other medications in two weeks: Birth control, prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. Patient stated that she had experienced nausea, vomiting and diarrhea since approximately 6 hours post vaccination. I also experienced chills, body aches and stomach cramps. The outcome of the events were recovering.

Other Meds:

Current Illness:

ID: 1665641
Sex: F
Age:
State: NJ

Vax Date: 07/03/2021
Onset Date: 07/03/2021
Rec V Date: 09/02/2021
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: I received the first dose of the Pfizer Covid-19 vaccine, and I had an allergic reaction; her eyes were itchy, red and swollen; her eyes were itchy, red and swollen; her eyes were itchy, red and swollen; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number E40584), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergy Allergic to pollen. The patient's concomitant medications were not reported. The patient previously took benadryl and experienced eye swelling, benadryl and experienced hypoaesthesia oral. No Prior Vaccinations (within 4 weeks). No Family Medical History Relevant to AE. No relevant Tests. History of all previous immunization with the Pfizer vaccine considered as suspect: N/A; this was the patient's first dose. No additional Vaccines Administered on Same Date of the Pfizer Suspect. On 03Jul2021 (4 hours after the vaccine) patient experienced i received the first dose of the pfizer covid-19 vaccine, and i had an allergic reaction, her eyes were itchy, red and swollen. When I went to get the second dose of the vaccine I was told I couldn't get it and to call you to report what happened to me. Is there a problem if I can't get the second dose? Caller confirms no, she does not work as a healthcare professional, but states she takes care of her girl. She took another Tylenol again since the medication had already gone away. She clarifies she took another Tylenol and just a bit later, the swelling in her eyes started to go down. She confirms her eyes had been really swollen. Caller clarifies further that when she took the Tylenol, it helped her feel better. She confirms she is not still experiencing the swelling. She explains the day she took the pill before she went to get the Pfizer vaccine, when she came back, everything was okay. When the pill effects went away, and the injection started giving its reaction, she could see it. So, she took another Tylenol because she was afraid of the swelling at night when she was sleeping. Thankfully, nothing got swollen again. She took Tylenol every 3 hours, just to not get another reaction so her eyes wouldn't get swollen. On the second day, she didn't take anything and everything was okay. For example, she has taken Motrin. Before she could take any medicine and wouldn't get any allergy, but now, she gets a reaction and her eyes get swollen. Caller states she even had to go to Emergency room because her eyes got swollen and her throat got swollen as well. This is also when she took Benadryl. She clarifies this happened like a month ago. She was inside her house and went outside to the patio. Because the pollen was high that day, her eyes and nose started to be itchy and she started sneezing a lot. She was sneezing and sneezing. She went inside and she took Benadryl. Instead of the Benadryl lowering her symptoms, she started to get swollen and swollen. Her eyes were swollen and it felt like her lips were getting asleep/ numb. She ended up going to the Emergency Room because she felt like her whole face had gotten swollen. She states this was her first time taking Benadryl because she typically does not suffer from anything or get anything. She mentions she has taken Claritin but has never gotten any reaction with it, but Benadryl is what she had at hand. With the Benadryl, she never thought she was going to get swollen, but she did. Caller explains she doesn't have any NDC, Lot, or expiry date for the Benadryl. She states its the really small pills that the pharmacy sells, like the count is 4 or 5. The rest she threw away because she felt like it was best not to have them. Description of complaint: Caller was reporting allergic reaction after first dose of the Pfizer Covid 19 vaccine, and explains 2 years ago, if she took medicine before, she was not allergic to anything. But now, she is allergic to pollen and everything. She mentions about a month ago, the pollen was high that day, her eyes and nose started to be itchy and she started sneezing a lot. She was sneezing and sneezing. She went inside and she took Benadryl. Instead of the Benadryl lowering her symptoms, she started to get swollen and swollen. Her eyes were swollen and it felt like her lips were getting asleep/ numb. She felt like her whole face had gotten swollen. She states this was her first time taking Benadryl because she typically does not suffer from anything or get anything. She mentions she has taken Claritin but has never gotten any reaction with it, but Benadryl is what she had at hand. With the Benadryl, she never thought she was going to get swollen, but she did. Caller explains she doesn't have any NDC, Lot, or expiry date for the Benadryl. She states its the really small pills that the pharmacy sells, like the count is 4 or 5. The rest she threw away because she felt like it was best not to have them. Therapeutic measures were taken as a result of all events includes tylenol. She is just going to go to the doctor today so she can go to get a letter to certifying that she is not able to get the vaccine and to let the withheld know that he doctor is saying no. The outcome for all events was unknown. No Emergency Room/ Physician Office visit required. Follow-up(26Jul2021) This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: Follow-up(26Jul2021)This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: Follow-up (05Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1665642
Sex: U
Age:
State:

Vax Date: 06/23/2021
Onset Date: 07/04/2021
Rec V Date: 09/02/2021
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: Headache; sensitivity to light; experience of nausea and dizziness and I still get that feeling now; experience of nausea and dizziness and I still get that feeling now; This is a spontaneous report from a Contactable consumer (patient, self-reporting). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN0181 and expiration date was not reported), dose 1 via an unspecified route of administration on 23Jun2021 as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. On June 23rd Patient took the first Pfizer COVID Vaccine now that week patient was fine but the week of 4Jul2021 and started getting strong headache some sensitivity to light and some experience of nausea and dizziness and still get that feeling now. Patient was supposed to have the 2nd vaccine last week but belated twice (Missed dose) because patient still feel those things, so do not know whether that's common after the first week. The outcome of the event was not recovered. Follow-up (27Aug2021): Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951226 similar report from same reporter

Other Meds:

Current Illness:

ID: 1665643
Sex: M
Age:
State: NE

Vax Date: 04/08/2021
Onset Date: 07/21/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:unknown; Comments: I have done: EKG, and blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs.; Test Name: stress test; Result Unstructured Data: Test Result:unknown; Comments: I have done: EKG, and blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs.; Test Name: CT scan; Result Unstructured Data: Test Result:unknown; Comments: I have done: EKG, and blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs.; Test Name: Echo; Result Unstructured Data: Test Result:unknown; Comments: I have done: EKG, and blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs.; Test Name: EKG; Result Unstructured Data: Test Result:unknown; Comments: I have done: EKG, and blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs.; Test Name: PFT; Result Unstructured Data: Test Result:unknown; Comments: I have done: EKG, and blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: I had chest pain; my left arm went numb; Pain is always there. Sometimes I feel it in my arm; I get short of breath; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153, Expiration date: not reported, Age at vaccination: 43-year-old) via an unspecified route of administration in right arm on 08Apr2021 04:00 PM as single dose for COVID-19 immunization. The patient medical history included seasonal allergies. Concomitant medications included Zyrtec D, Mucinex DM and Flonase. On 21Jul2021, patient experienced chest pain, numbness of extremities, pain, short of breath. Lab test included EKG, blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment as antibiotics received for events. No other vaccine was administered in four weeks. Covid was not present prior vaccination. Patient had no known allergies. The outcome of events was recovered on an unknown date with sequel. Follow-up attempts are completed. No further information is expected.

Other Meds: ZYRTEC DAIICHI; MUCINEX DM; FLONASE [MOMETASONE FUROATE]

Current Illness:

ID: 1665644
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Gabapentin (captured as suspects) they gave me, that made me sick and vomit; Gabapentin (captured as suspects) they gave me, that made me sick and vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration on 03May2021 (at the age 57-year-old) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation; gabapentin (Formulation: Unknown), via unspecified route of administration, from unspecified date, unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient stated 'gabapentin (captured as suspects) they gave me, that made me sick and vomit' on an unspecified date. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1665645
Sex: F
Age:
State: AL

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fever for 4days so far (073121) from date of shot; chest burning sensation; congestion; chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot Number: EW0173) via an unspecified route of administration, administered in right arm on 28Jul2021 14:30 (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included meningococcal vaccine a/c/y/w and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on 26Jul2021. On 28Jul2021 23:00, the patient experienced running fever for 4days so far (073121) from date of shot, chest burning sensation, congestion, chills and fatigue and treatment received for the events were unknown. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: MENINGOCOCCAL VACCINE A/C/Y/W; TDAP

Current Illness:

ID: 1665646
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: I feel like Dizzy; My both eyes are like a little bit red; This is a spontaneous report from a contactable consumer (Patient). A patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I feel like Dizzy and My both eyes are like a little bit red. It was reported that when probed for the concern, consumer stated, he got his first Covid Vaccine yesterday and today he didn't know if it was the part of it or not but he felt like dizzy and his both eyes were like a little bit red. Outcome of all the events was unknown. Information on lot number/batch number has been requested.

Other Meds:

Current Illness:

ID: 1665647
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Spot where I had the shot is very swollen and red; Spot where I had the shot is very swollen and red; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: FA7484), via an unspecified route of administration on an unspecified date, dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had the vaccine on Saturday. The patient reported that the spot where he/she had the shot was very swollen and red but noticed it was magnetic. The patient put a quarter or penny or whatever on that spot it stays there until he/she removed it. The patient was asking what was magnetic in that shot. The clinical outcome for events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1665648
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: experiencing pain; numbness on right side of shoulder and then going down now the area is expanding; This is a spontaneous report from a contactable consumer (Patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date: was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered in Deltoid Left on an unspecified date as dose 1, single for COVID-19 immunization and experienced slight fever. The patient experienced experiencing pain, and numbness on right side of shoulder and then going down now the area is expanding on an unspecified date. Consumer stated, he have a problem and it seemed as if it is not only his but he have the vaccine but, he thought this effect will go away and it never went away and first shot he had because he took the Pfizer, the first one on left shoulder and 2nd one was on the second shoulder, he mean on right shoulder and initially he did get any experience any side effect other than just slight fever but now he experiencing pain that never went away, it's just increasing, and increasing, and numbness on right side of shoulder and then going down now the area is expanding and he tried to do some exercises and his wife experiencing the same thing and even other friends that also receive the same vaccine on the same day are also complaining the same thing. The outcome of events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100994049 same reporter/ drug, different AE/ patient;US-PFIZER INC-202100994048 same reporter/ AE/ drug, different patient

Other Meds:

Current Illness:

ID: 1665649
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: tiredness; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date. The patient experienced tiredness on an unspecified date. The patient stated she has received both doses of the Pfizer BioNtech covid 19 vaccine series and the only side effect was tiredness. Patient was now seeking information regarding the 3rd booster dose of the vaccine. Response was given from CONS-Booster Dose (US) (v1.0) as well as press release from 08Jul2021 (website link). The outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1665650
Sex: F
Age:
State: IN

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/02/2021
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: She is experiencing tiredness; Caller states his wife is lightheaded/dizzy and weak; Caller states his wife is lightheaded, dizzy and weak; This is a spontaneous report from a contactable consumer (patient's husband) reported for Patient. A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, NDC number and Expiry Date: Not Provided) via an unspecified route of administration on 09Aug2021 at 14:05 as dose 2, single for COVID-19 immunization (vaccinated at the age of 90-years). The patient medical history and Concomitant medications were not provided. The reporter stated that his wife (patient) was lightheaded, dizzy and weak on 09Aug2021. The reporter questioned what the patient should do, he further stated that if Pfizer gives the shots, they should know what to do about the side effects and his wife, was not given information sheet, after her vaccine, about the common side effects, he wanted to have information if her side effects had been reported. The outcome of all the events was unknown.

Other Meds:

Current Illness:

ID: 1665651
Sex: U
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
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: Have a regular pain that's feels like someone punched in the arm like my muscle hurts over it; Neck started itching; Whole entire neck was just itching terrible and all night I was itching; Covered in hives; Still covered in hives like they didn't go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso; Have a regular pain that's feels like someone punched in the arm like my muscle hurts over it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: not reported), via an unspecified route of administration, administered in right arm in Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 in May2021 (a confirm case). The concomitant medications for patient were not reported. It was reported that the patient had COVID back in May a confirm case and then was told by the doctor to get the vaccine (Unspecified vaccine) anyway and she told the patient to get it at Saturday, so the patient went and got first dose. The patient got vaccinated yesterday morning on right arm, it was maybe like 10 O'clock or 11 O'clock something like that. It was Saturday whenever it was 8th or 7th the patient did not know. And it was reported that "I got it in my right arm and probably about 9 O'clock at night my neck started", On an unspecified date in Aug2021, the patient reported to "have a regular pain that's feels like someone punched in the arm like my muscle hurts over it", but according to patient that was not the big deal but about 9 at night "neck started itching; whole entire neck was just itching terrible and all night I was itching". The patient thought maybe the patient was getting bitten by mosquito or something but then the patient went to bed. Then the patient woke up in morning and the patient was "covered in hives; still covered in hives like they didn't go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso". The patient reported that the patient did not get hives. So, that was not, the only thing the patient did different was to take the vaccine and the patient was covered in hives and it was 8 O'clock at night and the patient was still completely covered on torso. The patient did not want to take Benadryl or something and just wanted to know why the patient having hives. The patient did not want to take the second one if the patient getting the hives. The patient did not want to get any mail. Further probing could not be done as the consumer was unwilling to share any further information at that point of time. Hence limited information available over the call. The outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1665652
Sex: F
Age:
State: AL

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/02/2021
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: Muscle aches; Arm feels like it was punched, after first vaccine; Bad headache, after first vaccine; Slept for 3 hours, after first vaccine; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 58-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Aug2021 (at the age of 58-year-old) as dose 1, single for COVID-19 vaccination. Medical history included fibromyalgia, migraines, headache and muscle aches (muscle aches as well from the fibromyalgia). Concomitant medications were not reported. Historical vaccine included Influenza vaccine and usually got a headache. The patient got the first dose on 09Aug2021 (reported as today) and her second dose already scheduled. On 09Aug2021, the patient experienced arm feels like it was punched, muscle aches and a bad headache, after the vaccine. She came home from getting the vaccine and slept for 3 hours. She was not saying any of that was from the vaccine. The patient would like to know if a person had to quarantine after getting the vaccine. Outcome of the events were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1665653
Sex: F
Age:
State: AR

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 09/02/2021
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: Some component in the vaccine actually took away the pain and the weaknessfrom peripheral artery disease in legs; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER2613) via an unspecified route of administration (age at vaccination 71-year) on 23Apr2021 13:00 as dose 2, single for COVID-19 immunization. The medical history includes Peripheral artery disease in legs, pain, weakness from peripheral artery disease in legs, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number was Either EN or FN followed by either 208 or Z08) administered on 19Mar2021 for COVID-19 immunization. On 23Apr2021 the patient experienced some component in the vaccine actually took away the pain and the weakness from peripheral artery disease in legs. The caller is a consumer reporting she did not have any bad effects from the Pfizer Covid Vaccine. The caller states she literally had no bad effects from the Pfizer Covid Vaccine, but the caller had a positive effect. The caller states she can't seem to find a place to report this positive effect. Some component in the vaccine actually took away the pain and the weakness from peripheral artery disease in legs: The caller states some component in the Pfizer Covid Vaccine took away the pain and weakness from the peripheral artery disease in the caller's legs. The caller states this pain removal lasted for about 3 weeks. Caller states it began within; well, the caller received the second dose Pfizer Covid Vaccine around 1300. The caller states she did not have any bad side effects from either dose Pfizer Covid Vaccine, had things set up in the event that the caller did, but the caller did not have any bad side effects. The caller clarifies the pain removal began within hours of receiving the second dose Pfizer Covid Vaccine. The clinical outcome of the event was unknown. Description of product complaint: The caller states some component in the Pfizer Covid Vaccine took away the pain and weakness from the peripheral artery disease in the caller's legs. Caller states this began after receiving second dose Pfizer Covid Vaccine. Product strength and count size dispensed: N/A. Additional lot numbers: First dose: The caller states the lot number is kind of covered up with a sticker from the second dose on the vaccine card. Either EN or FN followed by either 208 or Z08. Second dose: ER2613. The sample of the product available to be returned was not requested. A final statement is not entered.

Other Meds:

Current Illness:

ID: 1665654
Sex: M
Age:
State: NY

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:Increase; Test Name: Blood presure; Result Unstructured Data: Test Result:145/95 +/- 10

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Tired; weakness; his is a spontaneous report from a contactable consumer. A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8727 and expiration dates were not reported), dose 1 via an unspecified route of administration in arm left on 13Apr2021 at 14:00 as single dose for COVID-19 immunisation. The patient's medical history included thyroid, hashimoto and allergy to penicillin and Levaquin from an unknown date and unknown if ongoing. The concomitant medication included levothyroxine sodium (SYNTHROID), clonazepam (KLONOPIN), escitalopram oxalate (LEXAPRO) and buspirone hydrochloride (BUSPAR) all products from an unknown date for an unknown indication. On 13Apr2021 at 14:00 the patient experienced tired and weakness for about a week after 1 dose of vaccine. The facility where the most recent COVID-19 vaccine was administered id reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received corrective treatment for the adverse event. The patient underwent lab test and procedure that is Heart rate: increase and blood pressure measurement: 145/95 +/- 10. The outcome of the events were not recovered. No Follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID; KLONOPIN; LEXAPRO; BUSPAR

Current Illness:

ID: 1665655
Sex: F
Age:
State:

Vax Date: 05/03/2021
Onset Date:
Rec V Date: 09/02/2021
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: Blood work; Result Unstructured Data: Test Result:Fine; Test Name: Liver; Result Unstructured Data: Test Result:Fine

Allergies:

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

Symptoms: She had a bad taste in her mouth she couldn't get rid of; She felt tired but nothing bad/ she felt so exhausted; Off balance; Not a normal feeling at all/ She started to feel weird; Her mouth started to feel odd, and her palate went from pink to a strange color.; She didn't feel comfortable driving and that lasted a long time.; She also said that when she went to sleep she was very asleep; She usually turns her head upside down to brush her hair three times a day and she was unable to do that; This is a spontaneous report from a contactable consumer. This contactable 52-year-old female consumer (patient) reported for herself. This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 1 via an unspecified route of administration on 03May2021 as dose 1, single for COVID-19 immunisation. The patient's medical history included vestibular disorder from an unknown date and unknown if ongoing She gets "vestibular" every so often. The patient's concomitant medications were not reported. The patient experienced she had a bad taste in her mouth she couldn't get rid of, she felt tired but nothing bad/ she felt so exhausted, off balance, not a normal feeling at all/ she started to feel weird, her mouth started to feel odd, and her palate went from pink to a strange color, she didn't feel comfortable driving and that lasted a long time, she also said that when she went to sleep she was very asleep, she usually turns her head upside down to brush her hair three times a day and she was unable to do that. Reporter enquired that how long does the vaccine last in your system and would it still last that long since there was a large gap in between my first and second dose and also enquired 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine. The response included that on 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of Landmark COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) was effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose. Vaccine was 100% effective in preventing severe disease as defined by the Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the (FDA). Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage was prevalent. Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose. Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at: withheld: Please note that the "Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity" SRD has been updated to include the Press Release information. The caller enquired that the female, aged 52, received first dose of the Pfizer BioNTech Covid 19 vaccine on 03May2021. She gets "vestibular" every so often, and after the vaccine she felt tired but nothing bad. She said she doesn't do well with a lot of medication. She started to feel weird, off balance, not a normal feeling at all, her mouth started to feel odd, and her palate went from pink to a strange color. She also said she felt so exhausted that she didn't feel comfortable driving and that lasted a long time. She also said that when she went to sleep, she was very asleep, which was unusual for her because she's not typically a heavy sleeper. She had a bad taste in her mouth she couldn't get rid of. She usually turns her head upside down to brush her hair three times a day and she was unable to do that. She was concerned about her liver, but when she went to see the doctor her liver and blood work came back fine. In the past month she is starting to feel normal again, but why she delayed getting the second dose. She wants to know if it's okay to receive the second dose this long after the first dose or if she needs to restart the series. The patient underwent lab tests and procedures which included blood test was fine, liver function test was fine, on an unspecified date. The outcome of the events was recovered on an unspecified date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow u

Other Meds:

Current Illness:

ID: 1665656
Sex: M
Age:
State: NJ

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 09/02/2021
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: didn't like the way he felt; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, Jun2021 (Batch/Lot number was not reported)), dose 1 via an unspecified route of administration on as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced didn't like the way he felt on an unspecified date. Caller states she was calling to have some questions answered regarding her son who a withheld old male is. Caller states her son received his first dose of the vaccine in mid-June and he was fearful of getting the second dose and had putting it off. Caller states all of his friends have been deathly sick after the second dose, and he was afraid to get it. Caller would like to know if you had significant side effects with the first dose will you have worse side effects with the second dose. Caller states her son stated that he didn't like the way he felt and thought the side effects were horrible and he was afraid to receive the second dose. Caller states she didn't think his side effects were that bad. Caller would like to know what the recommendation regarding the second dose is if you had a reaction to the first dose. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Caller enquired that it would like to know for people who have a severe allergic reaction to the first dose how effective is the vaccine and what do people do with just the one dose. Caller would like to know if it has been too long of a wait for her son to receive the second dose. Caller states it had about 8 weeks. Caller would like to know if the series would need to be restarted if given after 6 weeks. Caller would like to know if her son can receive a lower dose for his second dose. Caller would like to know if children who are 12 receive the same dose and if not, when will the lower dose be available. Side effects with first dose of Pfizer Covid vaccine, and all this friend got deathly sick from the second dose. Caller did not have any details to provide. She did not think they were serious, but her son thought they were. He was scared to get the second dose, got first dose in mid JUN 2021, has not gotten second dose. If he does get the dose it will be outside the 42-day range. Agent states the caller disconnected during transfer. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1665657
Sex: F
Age:
State:

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 09/02/2021
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: wasn't able to take it until recently again and I don't know what's going to happen to me if I take it and it's been almost like 3 months."; Have vestibular issue and it agitated; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reported for self. A female patient of an unspecified age, received second dose of BNT162B2 (Solution for injection, Batch/lot number: ER8736) via an unspecified route of administration, on an unknown date in May2021, as dose 2 single for Covid-19 immunization. Medical history included Have vestibular issue. Concomitant medications were not reported. The patient received second dose 2 and a half months after the first, she was Worried about the efficacy because waited longer than 21 days; Took the vaccine in May but she wasn't able to take it until recently. Have vestibular issue and it was agitated . The patient wanted to know if there will be some kind of Adverse reaction to that." The patient stated that I took the vaccine in May but I wasn't able to take it until recently again and I don't know what's going to happen to me if I take it and it's been almost like 3 months." The out-come of the events was unknown.

Other Meds:

Current Illness:

ID: 1665658
Sex: M
Age:
State:

Vax Date: 08/05/2021
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
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: Headache, after first vaccine; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 05Aug2021 (Thursday) as single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021 the patient experienced headache, after first vaccine. The patient stated that he was afraid, the second shot will be worse, and that was scary. The patient heard that the second shot, was worse than the first shot and all the side effects more with the second shot, than the first shot. The patient wanted to know how long do side effects last. The patient stated that few people that he know who got vaccinated, some people had more side effects than others, and some of the side effects went away quicker. He stated that he specifically had a headache, and last night took paracetamol (TYLENOL) and was effective. Outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am