VAERS 2021 Database www.vaers.hhs.gov

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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: 1740021
Sex: M
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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 Name: LVEF; Result Unstructured Data: 65%; Test Name: Peak cardiac troponin I; Result Unstructured Data: 18.94 ng/mL.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: COVID-19 Vaccine and Myocarditis. 2021;00:1-2 No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: 65% 65%. On an unknown date, Troponin I: 18.94 ng/ml 18.94 ng/mL. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related. Concomitant medications were not reported. Therapy for the event was not reported. It was reported that all patients recovered within 6 days of their presentation with complications. This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications. This literature report concerns a 24 year old male patient who experienced myocarditis unknown duration after vaccination with second dose of mRNA-1273. The occurrence of the event is consistent with the current understanding of the mechanism of action of the vaccine (known to cause the event).The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-317848, MOD-2021-317975, MOD-2021-317976, MOD-2021-317977 (Patient Link).; Sender's Comments: This literature report concerns a 24 year old male patient who experienced myocarditis unknown duration after vaccination with second dose of mRNA-1273. The occurrence of the event is consistent with the current understanding of the mechanism of action of the vaccine (known to cause the event).The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1740022
Sex: F
Age: 43
State: FL

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: migraine; injection site big red dot or rash; had a chill; swollen lymph nodes; pain in her left breast; pain in her neck on the left; she did not feel good; felt like she was getting sick; pain under her left arm/pain in her left leg; pain in her arm/pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm/pain in her left arm), BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good) and ILLNESS (felt like she was getting sick) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm/pain in her left arm). On 13-Sep-2021, the patient experienced BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good), ILLNESS (felt like she was getting sick), PAIN (pain under her left arm/pain in her left leg ), CHILLS (had a chill) and LYMPHADENOPATHY (swollen lymph nodes). On 16-Sep-2021, the patient experienced VACCINATION SITE RASH (injection site big red dot or rash). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, PAIN IN EXTREMITY (pain in her arm/pain in her left arm) had resolved and BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good), ILLNESS (felt like she was getting sick), PAIN (pain under her left arm/pain in her left leg ), MIGRAINE (migraine), CHILLS (had a chill), LYMPHADENOPATHY (swollen lymph nodes) and VACCINATION SITE RASH (injection site big red dot or rash) 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. Patient had pain in her arm, which lasted for 3 days. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Newevent Injection site big red dot or rash was added.

Other Meds:

Current Illness:

ID: 1740023
Sex: M
Age: 60
State: NY

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 09/28/2021
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: AFT (Alpha fetoprotein); Result Unstructured Data: High, Found in Blood test; Test Name: Blood platelets; Result Unstructured Data: Low, blood platelets are through the floor

Allergies:

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

Symptoms: After the vaccine he felt bad from his stomach/ he always had stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included Tumorectomy (He had an ablation to kill a 5 centimeters tumor) in August 2021. Concurrent medical conditions included Immunocompromised, HIV disease (For many years), Cancer (For many years), Cirrhosis liver (For many years), Tumour (Cancerous and he has been given Chemotherapy treatment and an Embolization) and Heartburn. Concomitant products included OMEPRAZOL [OMEPRAZOLE] for Heartburn, ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach). At the time of the report, ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alpha 1 foetoprotein: high (High) High, Found in Blood test. On an unknown date, Platelet count: low (Low) Low, blood platelets are through the floor. Treatment information was not provided. Patient stated that after second dose he received Flu shot on an unknown date.

Other Meds: TRIUMEQ; OMEPRAZOL [OMEPRAZOLE]

Current Illness: Cancer (For many years); Cirrhosis liver (For many years); Heartburn; HIV disease (For many years); Immunocompromised; Tumour (Cancerous and he has been given Chemotherapy treatment and an Embolization)

ID: 1740024
Sex: M
Age: 60
State: PA

Vax Date: 09/03/2021
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: knocked out; sweaty/had sweats; could not take a shower; had no energy; felt like he had flu; slept all day; did not eat much; a fever that went highest 100.8 F/fever never went more than 101 F; achiness; extremely tired/extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (knocked out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: FLU VACCINE VII on 03-Sep-2021. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (knocked out) (seriousness criterion medically significant), HYPERHIDROSIS (sweaty/had sweats), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), INFLUENZA LIKE ILLNESS (felt like he had flu), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), PYREXIA (a fever that went highest 100.8 F/fever never went more than 101 F), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue). At the time of the report, LOSS OF CONSCIOUSNESS (knocked out), HYPERHIDROSIS (sweaty/had sweats), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), INFLUENZA LIKE ILLNESS (felt like he had flu), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), PYREXIA (a fever that went highest 100.8 F/fever never went more than 101 F), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue) outcome was unknown. No concomitant medication information was provided No treatment product information was provided. other concomitant medication includes vitamins and Blood pressure medication. Company comment: Atorvastatin) who experienced the unexpected serious event of loss of consciousness and non-serious event of hyperhidrosis, somnolence, eating disorder, Influenzalike illness, loss of personal independence, and asthenia and expected events of pyrexia, myalgia and fatigue . The events occurred following an unspecified period after the second dose of mRNA-1273 (onset date provided). The rechallenge was unknown. Causality for the events was not provided by the reporter. The events of pyrexia, myalgia and fatigue are consistent with the current understanding of the mechanism of action of mRNA-1273.The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-320106 (Patient Link).; Sender's Comments: Atorvastatin) who experienced the unexpected serious event of loss of consciousness and non-serious event of hyperhidrosis, somnolence, eating disorder, Influenzalike illness, loss of personal independence, and asthenia and expected events of pyrexia, myalgia and fatigue . The events occurred following an unspecified period after the second dose of mRNA-1273 (onset date provided). The rechallenge was unknown. Causality for the events was not provided by the reporter. The events of pyrexia, myalgia and fatigue are consistent with the current understanding of the mechanism of action of mRNA-1273.The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: LIPITOR

Current Illness:

ID: 1740025
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: 14 year old. he got1 injection of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna) had resolved. Concomitant medications were not provided. Treatment medications were not provided. Events included I will monitor the symptoms if and will respond later

Other Meds:

Current Illness:

ID: 1740026
Sex: F
Age: 58
State: GA

Vax Date: 01/16/2021
Onset Date: 02/13/2021
Rec V Date: 09/28/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination. The patient's past medical history included Multiple myeloma and Bone marrow transplant NOS (bone marrow cancer) in 2007. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (Sore arm). On 13-Feb-2021, MYALGIA (Sore arm) had resolved. No relevant concomitant medications were reported. Treatment information was unknown. This case was linked to MOD-2021-320886, MOD-2021-320895 (Patient Link).

Other Meds:

Current Illness:

ID: 1740027
Sex: F
Age: 58
State: SC

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022c21a) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1740028
Sex: M
Age:
State: NC

Vax Date: 09/09/2021
Onset Date: 09/05/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021; product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) and PRODUCT STORAGE ERROR (product storage error) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications information was not reported. No treatment medications were provided. 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond use-date (i.e. past 30 days at fridge temperature) of 9/5/21. This case was linked to MOD-2021-320876 (Patient Link).; Sender's Comments: This case concerns a 26-year-old, male subject with no relevant medical history who was administered with an expired Spikevax product for his second dose of the vaccine. No information on the first dose received by the patient. There were no reported AEs/SAEs associated with this expired product administration. The rechallenge was not applicable in this situation. Causality was not provided by the reporter or not applicable. The benefit-risk relationship of the vaccine is not affected by this report. This case was reviewed via RA

Other Meds:

Current Illness:

ID: 1740029
Sex: M
Age: 31
State: FL

Vax Date: 08/26/2021
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: pain in my shoulder; a little lightheaded; a little redness and swelling; it started itching; swelling at the injection site; excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas; a little swelling; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching) and VACCINATION SITE SWELLING (swelling at the injection site) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Asthma. On 26-Aug-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 ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: ALBUTEROL HFA; SYMBICORT; ZYRTEC ALLERGY

Current Illness:

ID: 1740030
Sex: F
Age: 72
State: OH

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 09/28/2021
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: 202102; Test Name: Chest X -ray; Result Unstructured Data: a bit of scarring on her lower left quadrant

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: it made her really really sick; perfused diaphoresis for days; could not get warm enough; she could not eat; she was hot and cold; really really weak; chills; nausea all the time; She did not take the second shot(restarted the series again); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (it made her really really sick), HYPERHIDROSIS (perfused diaphoresis for days), FEELING COLD (could not get warm enough), FEEDING DISORDER (she could not eat) and FEELING OF BODY TEMPERATURE CHANGE (she was hot and cold) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037821B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No specified medical history has been reported. The patient's past medical history included COVID-19 pneumonia (admitted her on the 7Feb2021 to the 11Feb2021) on 07-Feb-2021. Concurrent medical conditions included Psoriasis and Migraine. Concomitant products included DOVONEX; CALCIUM; COQ10 [PIPER NIGRUM;UBIDECARENONE]; DEPAKOTE; GABAPENTIN; GLUCOSAMINE & CHONDORITIN; LEVOTHYROXINE; MELATONIIN; METFORMIN; CLOFIBRATE; PRILOSEC [OMEPRAZOLE]; COREG; CYMBALTA; MAGNESIUM OXIDE; HUMALOG; LANTUS; AMERICAN GINSENG; OREGANO; cyproheptadine; ZETIA; GINKGO BILOBA; VITAMINS NOS for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (it made her really really sick), HYPERHIDROSIS (perfused diaphoresis for days), FEELING COLD (could not get warm enough), FEEDING DISORDER (she could not eat), FEELING OF BODY TEMPERATURE CHANGE (she was hot and cold), ASTHENIA (really really weak), CHILLS (chills), NAUSEA (nausea all the time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not take the second shot(restarted the series again)). At the time of the report, ILLNESS (it made her really really sick), HYPERHIDROSIS (perfused diaphoresis for days), FEELING COLD (could not get warm enough), FEEDING DISORDER (she could not eat), FEELING OF BODY TEMPERATURE CHANGE (she was hot and cold), ASTHENIA (really really weak), CHILLS (chills), NAUSEA (nausea all the time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not take the second shot(restarted the series again)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Chest X-ray: scarring (abnormal) a bit of scarring on her lower left quadrant. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She was diagnosed with Covid on 7Feb2021 and was sick for 2 weeks with a dry cough, anorexic, could not eat anything and if she did she got really nauseous. She then went to the hospital where they said she had Covid-pneumonia and admitted her on the 7Feb2021 to the 11Feb2021. On the Chest x-ray it showed that she had a bit of scarring on her lower left quadrant, but they gave her the okay to go ahead to take the first vaccine dose. Treatment information was not provided Concomitant medication included Garden of life (probiotic formulated by doctor) once daily. Patient was Put on 4 supplements. This case was linked to MOD-2021-321256.

Other Meds: DOVONEX; CALCIUM; COQ10 [PIPER NIGRUM;UBIDECARENONE]; DEPAKOTE; GABAPENTIN; GLUCOSAMINE & CHONDORITIN; LEVOTHYROXINE; MELATONIIN; METFORMIN; CLOFIBRATE; PRILOSEC [OMEPRAZOLE]; COREG; CYMBALTA; MAGNESIUM OXIDE; HUMALOG; LANTUS; AMERICAN GINS

Current Illness: Migraine; Psoriasis

ID: 1740031
Sex: F
Age: 51
State: NC

Vax Date: 08/26/2021
Onset Date: 09/09/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Blood work; Result Unstructured Data: blood work with no abnormal findings.; Test Date: 202109; Test Name: physical exam; Result Unstructured Data: weaker than normal

Allergies:

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

Symptoms: Irregular menses; lots of spotting recently; Dizziness; Exacerbation of her multiple sclerosis; Progressive leg weakness; Weaker than normal; This spontaneous case was reported by a physician and describes the occurrence of MULTIPLE SCLEROSIS (Exacerbation of her multiple sclerosis) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Multiple sclerosis and Reaction to previous exposure to any vaccine. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced MULTIPLE SCLEROSIS (Exacerbation of her multiple sclerosis) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Progressive leg weakness), ASTHENIA (Weaker than normal) and DIZZINESS (Dizziness). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular menses) and INTERMENSTRUAL BLEEDING (lots of spotting recently). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MULTIPLE SCLEROSIS (Exacerbation of her multiple sclerosis), MUSCULAR WEAKNESS (Progressive leg weakness), ASTHENIA (Weaker than normal), MENSTRUATION IRREGULAR (Irregular menses), INTERMENSTRUAL BLEEDING (lots of spotting recently) and DIZZINESS (Dizziness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood test: normal (normal) blood work with no abnormal findings.. In September 2021, Physical examination: abnormal (abnormal) weaker than normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information provided. For the past 7 days Patient had experienced progressive leg weakness and dizziness. Leg weakness was mostly over the past 48 hours, and felt similar to past MS exacerbations. Reported that, brain and spine MRI ordered but those have not been done yet. Patient's husband does not think patient was pregnant. Patient had a known prior vaccine sensitivity but was instructed by neurologist to get the vaccine anyways. Company comment: This case concerns a patient of 51-year-old female patient with relevant medical history of who experienced the unexpected event of Exacerbation of her multiple sclerosis. The event occurred 14 days after the first dose of the administration of mRNA-1273. The rechallenge was not applicable considering that the patient was not eligible for second dose at the time of the events. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Some vaccines have been found to be associated with reactivation of some immune mediated diseases.; Sender's Comments: This case concerns a patient of 51-year-old female patient with relevant medical history of who experienced the unexpected event of Exacerbation of her multiple sclerosis. The event occurred 14 days after the first dose of the administration of mRNA-1273. The rechallenge was not applicable considering that the patient was not eligible for second dose at the time of the events. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Some vaccines have been found to be associated with reactivation of some immune mediated diseases.

Other Meds:

Current Illness:

ID: 1740032
Sex: F
Age: 72
State: OH

Vax Date: 03/25/2021
Onset Date: 08/18/2021
Rec V Date: 09/28/2021
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: Perfused diaphoresis; really anorexic again; could not eat for 2 weeks; trouble drinking; really sick; got dehydrated; really nauseous; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking) and ILLNESS (really sick) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037821B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (sick for 2 weeks with a dry cough, anorexic, could not eat anything, nauseous) on 07-Feb-2021, COVID-19 pneumonia (admitted in hospital from 7-Feb-2021 to 11-Feb-2021) and Chest X-ray (showed a bit of scarring on the lower left quadrant ). Concomitant products included METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Migraine, CALCIPOTRIOL (DOVONEX) for Psoriasis, CALCIUM, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], VALPROATE SEMISODIUM (DEPAKOTE ER), GABAPENTIN (GABAPENTIN "PCD"), CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (1120 GLUCOSAMINE & CHONDROITINE), LEVOTHYROXINE, MELATONINE, METFORMIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), CARVEDILOL (COREG), CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), EZETIMIBE (ZETIA), MAGNESIUM OXIDE, GINKGO BILOBA, PANAX QUINQUEFOLIUS (GINSENG AMERICANO) and ORIGANUM VULGARE (OREGANO) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills) had resolved. Treatment information was not provided. The patient also took concomitant medications such as garden of life (probiotic formulated by physician) once daily and vitamin 1000 mg (200mg total daily). This case was linked to MOD-2021-321229 (Patient Link).

Other Meds: DOVONEX; CALCIUM; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECA; DEPAKOTE ER; GABAPENTIN "PCD"; 1120 GLUCOSAMINE & CHONDROITINE; LEVOTHYROXINE; MELATONINE; METFORMIN; REGLAN [METOCLOPRA

Current Illness:

ID: 1740033
Sex: F
Age: 60
State: CA

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 09/28/2021
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: loss my sense of smell; loss my sense of taste; This spontaneous case was reported by a non-health professional and describes the occurrence of ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of taste) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 016B21A) for COVID-19 vaccination. The patient's past medical history included Cellulitis from 19-Aug-2021 to 24-Aug-2021 and Hysterectomy in July 2008. Concurrent medical conditions included Pseudomyxoma peritonei (surgery) since 28-May-2008, Lichen sclerosus (Honey) since 22-Nov-2012, Laryngopharyngeal reflux since 10-May-2014, UTI (Antibiotics) since 05-Nov-1964, Asthma (Allergy shots) since 12-Feb-1975, OA knee, Allergy to antibiotic (Flagyl allergy), Peanut allergy (Peanuts allergies), Bee sting hypersensitivity (Bee stings allergy), Drug allergy (Oral steroids allergy), Allergy to topical drugs (topical steroids allergy), Allergy to antibiotic (clindamycin allergy), Drug allergy (macrodantin allergy), Drug allergy (decongestants allergy), Allergic reaction to analgesics (dilaudid allergy), Drug allergy (Antihistamines allergy minus), Allergy to nuts (Allergy to all nuts), Allergy to antibiotic (Allergy to cipro), Allergy to antibiotic (Augmentin allergy) and Drug allergy (Sulfa allergy). Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (XANAX) for Muscle spasm, SIMETICONE (GAS X) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of taste). At the time of the report, ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of taste) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatments was provided by the reporter. This case was linked to MOD-2021-321274 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: First and second dose information,Historical conditions, current conditions, Allergic status Concomitant medications were added.

Other Meds: XANAX; GAS X

Current Illness: Allergic reaction to analgesics (dilaudid allergy); Allergy to antibiotic (Flagyl allergy); Allergy to antibiotic (clindamycin allergy); Allergy to antibiotic (Augmentin allergy); Allergy to antibiotic (Allergy to cipro); Allergy to nuts (Allergy to all nuts); Allergy to topical drugs (topical steroids allergy); Asthma (Allergy shots); Bee sting hypersensitivity (Bee stings allergy); Drug allergy (Sulfa allergy); Drug allergy (Oral steroids allergy); Drug allergy (macrodantin allergy); Drug allergy (decongestants allergy); Drug allergy (Antihistamines allergy minus); Laryngopharyngeal reflux; Lichen sclerosus (Honey); OA knee; Peanut allergy (Peanuts allergies); Pseudomyxoma peritonei (surgery); UTI (Antibiotics)

ID: 1740034
Sex: M
Age: 63
State: VA

Vax Date: 08/12/2021
Onset Date: 08/01/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Name: Blood glucose; Result Unstructured Data: 250 to 300; Test Date: 20210812; Test Name: Blood sugar; Result Unstructured Data: blood sugar went down to 160

Allergies:

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

Symptoms: Blood sugar better controlled; Sore left injection site arm; Got the flu shortly after; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled), INFLUENZA (Got the flu shortly after) and VACCINATION SITE PAIN (Sore left injection site arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D1A) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DEGLUDEC (TRESIBA FLEXTOUCH) and INSULIN ASPART (NOVOLOG) for Type 2 diabetes mellitus, METFORMIN for an unknown indication. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled) and VACCINATION SITE PAIN (Sore left injection site arm). In August 2021, the patient experienced INFLUENZA (Got the flu shortly after). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled), INFLUENZA (Got the flu shortly after) and VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Blood glucose: 160 (abnormal) blood sugar went down to 160. On an unknown date, Blood glucose: 250 to 300 (High) 250 to 300. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not reported. The reporter states that the patient received first dose of Moderna Covid-19 vaccine and patient noticed that blood sugar was dropped, and patient blood sugar was running between 250 to 300 after the first dose of vaccine patient blood sugar went down to 160 and reporter states that the Patient was struggled to manage type 2 diabetes and taking insulin shots, after first dose patient diabetes seemed easier to control and patient got flu shortly after couldn't really exercise much. patient taking Metformin and other medications . This case was linked to MOD-2021-321336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received.Concomitant medications were added, new event influenza was added.

Other Meds: TRESIBA FLEXTOUCH; METFORMIN; NOVOLOG

Current Illness: Type 2 diabetes mellitus

ID: 1740035
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: sore right injection site arm; headache; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired) in a 70-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 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 VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information were provided. No treatment information were provided. As per source document the age at the time of event given is 10.

Other Meds:

Current Illness:

ID: 1740036
Sex: M
Age: 76
State: FL

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: discomfort in arm; a little out of sorts for day and half; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in arm) and MALAISE (a little out of sorts for day and half) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 032L20A) for COVID-19 vaccination. The patient's past medical history included Surgery (has affected his memory.). On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LIMB DISCOMFORT (discomfort in arm) and MALAISE (a little out of sorts for day and half). At the time of the report, LIMB DISCOMFORT (discomfort in arm) and MALAISE (a little out of sorts for day and half) outcome was unknown. No concomitant medication listed. No treatment information provided. This case was linked to MOD-2021-321094. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: followup received and medical history was added.

Other Meds:

Current Illness:

ID: 1740037
Sex: F
Age: 52
State: MD

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: first dose arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (first dose arm pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E or F 21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (sulfur medication). Concomitant products included AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, VITAMIN 15 for an unknown indication. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (first dose arm pain). On 22-Aug-2021, MYALGIA (first dose arm pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications used by the patient included multivitamins and cardiac medication. No treatment medications was provided by the reporter. This case was linked to MOD-2021-322348 (Patient Link).

Other Meds: METFORMIN; AMLODIPINE; VITAMIN 15

Current Illness: Drug allergy (sulfur medication)

ID: 1740038
Sex: M
Age: 54
State: FL

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Kidney infection; kidney function effect; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) and RENAL IMPAIRMENT (kidney function effect) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant) and RENAL IMPAIRMENT (kidney function effect) (seriousness criterion medically significant). At the time of the report, KIDNEY INFECTION (Kidney infection) and RENAL IMPAIRMENT (kidney function effect) outcome was unknown. The concomitant medications were not provided. The Treatment information includes antibiotics. Company Comment : This case concerns a 54-year-old, male with unknown medical history, who experienced the unexpected events of kidney infection and renal impairment. The event occurred after the second dose of mRNA-1273 Moderna vaccine (Spikevax) with no precise onset date. The rechallenge was unknown/since no information regarding the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old, male with unknown medical history, who experienced the unexpected events of kidney infection and renal impairment. The event occurred after the second dose of mRNA-1273 Moderna vaccine (Spikevax) with no precise onset date. The rechallenge was unknown/since no information regarding the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1740039
Sex: F
Age: 63
State: WV

Vax Date: 03/11/2021
Onset Date: 09/16/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Sick for 2 days; Hard to walk up and down the stairs; Sweating; Shaking/a little shaky; freezing; Sore left arm/body aches; Extreme fatigue/exhaustion/feels exhausted; Headache; Fever (temperature not measured); Chills for 24hrs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 2 days), GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), TREMOR (Shaking/a little shaky) and FEELING COLD (freezing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 037B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Crohn's disease and Hashimoto's disease. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID), ZOLPIDEM TARTRATE (AMBIEN), MAGNESIUM MALATE, OMEGA-3 FATTY ACIDS, VITAMIN D [VITAMIN D NOS], VITAMIN K [VITAMIN K NOS], ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], GLUTATHIONE, PHOSPHATIDYL CHOLINE (LIPOSOMAL GLUTATHIONE), BORON and ZINC PICOLINATE for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced ILLNESS (Sick for 2 days), GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), TREMOR (Shaking/a little shaky), MYALGIA (Sore left arm/body aches), FATIGUE (Extreme fatigue/exhaustion/feels exhausted ), HEADACHE (Headache), PYREXIA (Fever (temperature not measured)) and CHILLS (Chills for 24hrs). 16-Sep-2021, the patient experienced FEELING COLD (freezing). In September 2021, ILLNESS (Sick for 2 days) had resolved. On 17-Sep-2021, CHILLS (Chills for 24hrs) had resolved. At the time of the report, GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), FEELING COLD (freezing), MYALGIA (Sore left arm/body aches), FATIGUE (Extreme fatigue/exhaustion/feels exhausted ), HEADACHE (Headache) and PYREXIA (Fever (temperature not measured)) outcome was unknown and TREMOR (Shaking/a little shaky) had not resolved. No treatment medication was provided.

Other Meds: NP THYROID; AMBIEN; MAGNESIUM MALATE; OMEGA-3 FATTY ACIDS; VITAMIN D [VITAMIN D NOS]; VITAMIN K [VITAMIN K NOS]; BABY ASPIRIN; VITAMIN C [ASCORBIC ACID]; LIPOSOMAL GLUTATHIONE; BORON; ZINC PICOLINATE

Current Illness: Crohn's disease; Hashimoto's disease

ID: 1740040
Sex: F
Age:
State: NY

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

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

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

Allergies:

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

Symptoms: little under the weather; A little tired; fever; chills; allergy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy) in a 22-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) 2 negative rapid tests and negative (Negative) negative PCR test. No concomitant medications were reported. This case was linked to MOD-2021-322232 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received, New events and the treatment medication added.

Other Meds:

Current Illness:

ID: 1740041
Sex: M
Age: 64
State: NY

Vax Date: 08/19/2021
Onset Date: 09/17/2021
Rec V Date: 09/28/2021
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: Some discomfort in his arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Some discomfort in his arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced LIMB DISCOMFORT (Some discomfort in his arm). At the time of the report, LIMB DISCOMFORT (Some discomfort in his arm) outcome was unknown. Concomitant medication were not provided by the reporter. Treatment medication were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1740042
Sex: M
Age: 54
State: NY

Vax Date: 04/18/2021
Onset Date: 06/01/2021
Rec V Date: 09/28/2021
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: ECG; Result Unstructured Data: came back negative, so it was told it was just a muscle pain.

Allergies:

Symptom List: Unevaluable event

Symptoms: pain is very light with the tablet but it starts moving through the body; muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder; muscle pain/muscle pain is moving right now/pain starts moving through the body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain is very light with the tablet but it starts moving through the body), ARTHRALGIA (muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder) and MYALGIA (muscle pain/muscle pain is moving right now/pain starts moving through the body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 040B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced MYALGIA (muscle pain/muscle pain is moving right now/pain starts moving through the body). On an unknown date, the patient experienced PAIN (pain is very light with the tablet but it starts moving through the body) and ARTHRALGIA (muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder). At the time of the report, PAIN (pain is very light with the tablet but it starts moving through the body), ARTHRALGIA (muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder) and MYALGIA (muscle pain/muscle pain is moving right now/pain starts moving through the body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (normal) came back negative, so it was told it was just a muscle pain.. Concomitant medication included Blood pressure medicine and Colestor tablet for sugar on the dinner. Treatment medication included Nephrotic 250 tablets and was advised to put cold on it and that used a hot water pouch and put the hot water on the arm and it helps but then it starts feeling pain again. The patient went two times to emergency where received medication for the pain and on it's second visit had an ECG done and bloodwork which both came back negative, so it was told it was just a muscle pain. The patient said the pain is very light with the tablet but it starts moving through the body. The patient then went to it's regular doctor who prescribed the same medicine, Nephrotic 250 mg tablets. Patient never had a muscle pain like this. In 10 to 15 years ago stopped the blood pressure medicine because it was under new medicine then got the pain, didn't want long pain from the medicine. This case was linked to MOD-2021-322257 (Patient Link).

Other Meds:

Current Illness: Blood pressure high

ID: 1740043
Sex: F
Age: 59
State: TN

Vax Date: 01/02/2021
Onset Date: 01/27/2021
Rec V Date: 09/28/2021
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: I have generally felt bad; Erythema Nodosum; tired and sluggish; left side of my face went numb; low energy for a couple of days; sore left injection site arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA NODOSUM (Erythema Nodosum) and HYPOAESTHESIA (left side of my face went numb) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA (left side of my face went numb) (seriousness criterion medically significant), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm) and CHILLS (chills). On 01-Jun-2021, the patient experienced ERYTHEMA NODOSUM (Erythema Nodosum) (seriousness criterion medically significant), FEELING ABNORMAL (I have generally felt bad) and FATIGUE (tired and sluggish). At the time of the report, ERYTHEMA NODOSUM (Erythema Nodosum), HYPOAESTHESIA (left side of my face went numb), FEELING ABNORMAL (I have generally felt bad), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm), CHILLS (chills) and FATIGUE (tired and sluggish) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant or treatment medication has been reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Company comment - This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected. This case was linked to MOD-2021-322417 (Patient Link).; Sender's Comments: This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.

Other Meds:

Current Illness:

ID: 1740044
Sex: U
Age:
State:

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 09/28/2021
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: made her arm a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (made her arm a little sore) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PAIN (made her arm a little sore). At the time of the report, VACCINATION SITE PAIN (made her arm a little sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1740045
Sex: F
Age: 66
State: MA

Vax Date: 02/25/2021
Onset Date: 08/30/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: strange tenderness on left side of breast; painful within her breast or lymph nodes; painful within her breast or lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E12A, 018B21A and 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Psoriasis. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes). At the time of the report, BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness: Psoriasis

ID: 1740046
Sex: F
Age: 32
State: WA

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Date: 20210918; Test Name: Body temperature; Result Unstructured Data: 102.7F

Allergies:

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

Symptoms: Head spinning; Blacked out; Fever of 102.7F; Chills; Sweating the whole night; Unable to sleep (just rest her eyes); Muscle cramps and/or muscle convulsions; Felling freezing; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)) and MUSCLE SPASMS (Muscle cramps and/or muscle convulsions) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps and/or muscle convulsions), FEELING COLD (Felling freezing) and CHILLS (Chills). On 18-Sep-2021, the patient experienced VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out) and PYREXIA (Fever of 102.7F). At the time of the report, VERTIGO (Head spinning) had not resolved and LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps and/or muscle convulsions), FEELING COLD (Felling freezing), PYREXIA (Fever of 102.7F) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Body temperature: 102.7 (High) 102.7F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 32 year old female, with no details on medical history provided, who experienced the unexpected event of LOSS OF CONSCIOUSNESS. The event occurred approximately one day after receiving a dose of Spikevax, which dose number is unknown. Rechallenge is unknown as there is no information about other doses of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of loss of consciousness was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria, it was classified as Non-serious.

Other Meds:

Current Illness:

ID: 1740047
Sex: F
Age: 59
State: NY

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 09/28/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: sore arm; did not get second shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Coronary artery disease. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (did not get second shot). At the time of the report, MYALGIA (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get second shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter. Company comment: This case concerns a 60-year-old, female patient with relevant medical history of coronary artery disease, who experienced the expected event of Myalgia and unexpected event of Product dose omission. The event of Myalgia occurred on an unknown date and the patient did not receive the second dose of the Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event of Myalgia happened after the first dose. The events were considered related to the product per the reporter's assessment. The event of Myalgia is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60-year-old, female patient with relevant medical history of coronary artery disease, who experienced the expected event of Myalgia and unexpected event of Product dose omission. The event of Myalgia occurred on an unknown date and the patient did not receive the second dose of the Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event of Myalgia happened after the first dose. The events were considered related to the product per the reporter's assessment. The event of Myalgia is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.

Other Meds:

Current Illness: Coronary artery disease

ID: 1740048
Sex: F
Age: 23
State: GA

Vax Date: 08/20/2021
Onset Date:
Rec V Date: 09/28/2021
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: still not coming; period should have come at the beginning of September; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (still not coming) and MENSTRUATION DELAYED (period should have come at the beginning of September) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-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 MENSTRUATION IRREGULAR (still not coming) and MENSTRUATION DELAYED (period should have come at the beginning of September). At the time of the report, MENSTRUATION IRREGULAR (still not coming) and MENSTRUATION DELAYED (period should have come at the beginning of September) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1740049
Sex: M
Age: 6
State: VA

Vax Date: 09/18/2021
Onset Date: 09/18/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administered Moderna vaccine to a 6 years old instead of Flu vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered Moderna vaccine to a 6 years old instead of Flu vaccine) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. Concomitant products included GUANFACINE HYDROCHLORIDE (TENEX) for an unknown indication. On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered Moderna vaccine to a 6 years old instead of Flu vaccine). On 18-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered Moderna vaccine to a 6 years old instead of Flu vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Pharmacist was doing immunizations today, She accidentally grabbed a Moderna Covid 19 Vaccine instead of a Flu vaccine and administered it to a pediatric (6years old) patient. No treatment medications were given.

Other Meds: TENEX

Current Illness:

ID: 1740050
Sex: F
Age: 57
State: CA

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 09/28/2021
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: left arm became numb; feeling extreme cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left arm became numb) and FEELING COLD (feeling extreme cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The patient's past medical history included Myositis. On 14-Apr-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 HYPOAESTHESIA (left arm became numb) and FEELING COLD (feeling extreme cold). At the time of the report, HYPOAESTHESIA (left arm became numb) and FEELING COLD (feeling extreme cold) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. The patient had ILB (abbreviation unknown) as prior health conditions. The patient was not on any concomitant medications. This case was linked to MOD-2021-322849, MOD-2021-322850 (Patient Link).

Other Meds:

Current Illness:

ID: 1740051
Sex: M
Age:
State: MA

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

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

Lab Data: Test Name: ADAMTS13; Result Unstructured Data: The PLASMIC score used to predict ADAMTS13 deficiency in suspected TTP patients was 7 points showing that the patient is at high risk of having severe ADAMTS13 deficiency, thus requiring emergent plasmapheresis. ADAMTS13 activity later resulted as <3%; Test Name: ADAMTS13; Result Unstructured Data: ADAMTS13 inhibitor was 6.6 BEU (normal <0.4).; Test Name: Total Bilirubin; Result Unstructured Data: total bilirubin 5.0 with indirect bilirubin predominance; Test Name: Fibrinogen; Result Unstructured Data: fibrinogen 417?mg/dL; Test Name: Lactate dehydrogenase; Result Unstructured Data: lactate dehydrogenase (LDH) 884?U/L; Test Name: Cardiopulmonary exam; Result Unstructured Data: The patient had a normal cardiopulmonary exam, and his neurological exam was intact with complete recovery of transient symptoms. Examination of the skin and mucosa did not show any petechiae, purpura, or active bleeding.; Test Name: Hemoglobin; Result Unstructured Data: hemolytic anemia; Test Name: haptoglobin; Result Unstructured Data: haptoglobin<10?mg/dL; Test Name: Platelet count; Result Unstructured Data: patient was reported to have normal platelet counts (130.000/uL) approximately three months before the presentation.; Test Name: Platelet count; Result Unstructured Data: platelet count 10???103/dL (baseline platelet count of 130???103/dL).; Test Name: COVID-19 PCR Test; Test Result: Negative ; Result Unstructured Data: patient's COVID-19 PCR test was negative.

Allergies:

Symptom List: Injection site pain

Symptoms: Recurrence of Thrombotic Thrombocytopenic Purpura; Transient right-sided weakness; Slurred speech; Paresthesia; This literature-study case was reported in a literature article and describes the occurrence of THROMBOTIC THROMBOCYTOPENIC PURPURA (Recurrence of Thrombotic Thrombocytopenic Purpura) and HEMIPARESIS (Transient right-sided weakness) in a 48-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 Thrombotic thrombocytopenic purpura (Refractory), COVID-19 (COVID-19 2 months before his presentation, which did not require hospitalization.) and Idiopathic thrombocytopenic purpura (diagnosed with ITP 5 years ago, which was treated with steroids and rituximab). Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN for Type 2 diabetes mellitus. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOTIC THROMBOCYTOPENIC PURPURA (Recurrence of Thrombotic Thrombocytopenic Purpura) (seriousness criterion medically significant), HEMIPARESIS (Transient right-sided weakness) (seriousness criterion medically significant), DYSARTHRIA (Slurred speech) and PARAESTHESIA (Paresthesia). The patient was treated with RITUXIMAB for Thrombotic thrombocytopenic purpura, at an unspecified dose and frequency. At the time of the report, THROMBOTIC THROMBOCYTOPENIC PURPURA (Recurrence of Thrombotic Thrombocytopenic Purpura), HEMIPARESIS (Transient right-sided weakness), DYSARTHRIA (Slurred speech) and PARAESTHESIA (Paresthesia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, ADAMTS13 activity assay: <3% (abnormal) The PLASMIC score used to predict ADAMTS13 deficiency in suspected TTP patients was 7 points showing that the patient is at high risk of having severe ADAMTS13 deficiency, thus requiring emergent plasmapheresis. ADAMTS13 activity later resulted as <3%. On an unknown date, ADAMTS13 inhibitor screen assay: 6.6 beu (High) ADAMTS13 inhibitor was 6.6 BEU (normal <0.4).. On an unknown date, Blood bilirubin: 5.0 (abnormal) total bilirubin 5.0 with indirect bilirubin predominance. On an unknown date, Blood fibrinogen: 417?mg/dl (abnormal) fibrinogen 417?mg/dL. On an unknown date, Blood lactate dehydrogenase: 884?u/l (abnormal) lactate dehydrogenase (LDH) 884?U/L. On an unknown date, Cardiopulmonary exercise test: normal (normal) The patient had a normal cardiopulmonary exam, and his neurological exam was intact with complete recovery of transient symptoms. Examination of the skin and mucosa did not show any petechiae, purpura, or active bleeding.. On an unknown date, Haemoglobin: 8.8?g/dl (Low) hemolytic anemia. On an unknown date, Haptoglobin: <10?mg/dl (abnormal) haptoglobin<10?mg/dL. On an unknown date, Platelet count: 130.000/ul (normal) patient was reported to have normal platelet counts (130.000/uL) approximately three months before the presentation. and 10x103/dl (abnormal) platelet count 10???103/dL (baseline platelet count of 130???103/dL).. On an unknown date, SARS-CoV-2 test: negative (Negative) patient's COVID-19 PCR test was negative.. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was temporarily withheld on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROMBOTIC THROMBOCYTOPENIC PURPURA (Recurrence of Thrombotic Thrombocytopenic Purpura), HEMIPARESIS (Transient right-sided weakness), DYSARTHRIA (Slurred speech) and PARAESTHESIA (Paresthesia) to be possibly related. Patient medical records elucidated that he had a diagnosis of TTP for eight years, a total of 4 episodes in the past for which he was treated with plasmapheresis, steroids, and rituximab. Further treatment options were not initiated since the patient was lost to follow-up in between his relapses. He was also diagnosed with ITP 5 years ago, which was treated with steroids and rituximab. Patient had a full recovery after a 10-day course of plasmapheresis in addition to glucocorticoids and rituximab. The patient was to complete outpatient rituximab therapy and steroid tapering with hematology follow-up on discharge. His platelet and hemoglobin count was normalized on the day of discharge. The second dose of the COVID-19 vaccine was deferred. Treatment information was also included Steroid. This case concerns a 48 year-old, male with a history of diabetes mellitus, Thrombotic thrombocytopenic purpura (Refractory), COVID-19 (COVID-19 2 months before his presentation, which did not require hospitalization.) and Idiopathic thrombocytopenic purpura , who experienced the unexpected events THROMBOTIC THROMBOCYTOPENIC PURPURA (seriousness criterion medically significant), CONDITION AGGRAVATED, HEMIPARESIS, DYSARTHRIA and PARAESTHESIA, all resolved . The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received by safety 17-Sep-2021 included an Email received contains no new information.; Sender's Comments: This case concerns a 48 year-old, male with a history of diabetes mellitus, Thrombotic thrombocytopenic purpura (Refractory), COVID-19 (COVID-19 2 months before his presentation, which did not require hospitalization.) and Idiopathic thrombocytopenic purpura , who experienced the unexpected events THROMBOTIC THROMBOCYTOPENIC PURPURA (seriousness criterion medically significant), CONDITION AGGRAVATED, HEMIPARESIS, DYSARTHRIA and PARAESTHESIA, all resolved . The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report

Other Meds: INSULIN

Current Illness: Type 2 diabetes mellitus

ID: 1740052
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: Body temperature; Result Unstructured Data: high fever 101.4

Allergies:

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

Symptoms: Have a high fever 24hrs after the vaccine. 101.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have a high fever 24hrs after the vaccine. 101.4) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Have a high fever 24hrs after the vaccine. 101.4). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PYREXIA (Have a high fever 24hrs after the vaccine. 101.4) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) high fever 101.4. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product information was provided.

Other Meds:

Current Illness:

ID: 1740053
Sex: F
Age: 75
State: AZ

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 09/28/2021
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: Couldn't get a deep breath of oxygen for about 6 weeks; Welt was kind of white; Didn't feel well; Injection site was hard and raised; Developed a huge welt, that looked like a giant hive at the injection site and was the size of a silver dollar; Tired; Injection site itched horribly for about a week; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't get a deep breath of oxygen for about 6 weeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSPNOEA (Couldn't get a deep breath of oxygen for about 6 weeks) (seriousness criterion medically significant), SKIN DISCOLOURATION (Welt was kind of white), MALAISE (Didn't feel well), VACCINATION SITE INDURATION (Injection site was hard and raised), VACCINATION SITE URTICARIA (Developed a huge welt, that looked like a giant hive at the injection site and was the size of a silver dollar), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Injection site itched horribly for about a week). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 25-Feb-2021, VACCINATION SITE INDURATION (Injection site was hard and raised) and VACCINATION SITE PRURITUS (Injection site itched horribly for about a week) had resolved. At the time of the report, DYSPNOEA (Couldn't get a deep breath of oxygen for about 6 weeks) had resolved and SKIN DISCOLOURATION (Welt was kind of white), MALAISE (Didn't feel well), VACCINATION SITE URTICARIA (Developed a huge welt, that looked like a giant hive at the injection site and was the size of a silver dollar) and FATIGUE (Tired) outcome was unknown. Concomitant product use was not provided by the reporter. Beginning 18-FEB-2021 she began having side effects. Patient developed a huge welt that looked like a giant hive at the injection site, and was the size of a silver dollar. She also stated the welt was kind of white. She stated that the injection site was hard and raised and itched horribly for about a week. She also didn't feel well and was tired. Patient further stated that she couldn't get a deep breath of oxygen for about 6 weeks. She stated that she has spoken to her doctor. Patient was now wondering if she should get the booster shot considering her side effects. Treatment for the events included use of lots of water. Company comment: This case concerns a 75-year-old female patient with no relevant medical history, who experienced the unexpected event of Dyspnea. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 75-year-old female patient with no relevant medical history, who experienced the unexpected event of Dyspnea. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1740054
Sex: M
Age: 14
State: MO

Vax Date: 08/02/2021
Onset Date: 08/02/2021
Rec V Date: 09/28/2021
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: Adolescent received Moderna COVID-19 vaccine/child was too young; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 014F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young) to be possibly related. No concomitant medications were provided. No treatment medications were reported. It was reported that Moderna instructed that if the child was between the ages of 12-17 that the second dose of Moderna covid vaccine should be given following 28 days from the first dose and hence the second dose was given. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Significant follow-up appended: Patient demographics, dose 1 and 2 details, event details added.

Other Meds:

Current Illness:

ID: 1740055
Sex: F
Age: 24
State: WA

Vax Date: 08/14/2021
Onset Date: 09/18/2021
Rec V Date: 09/28/2021
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: Body temperature; Result Unstructured Data: 100 degrees Fahrenheit

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: tongue is swelling a bit that she cannot see the uvula when she opens her mouth; hives around her neck; body temperature is now 100 degrees Fahrenheit; A bit nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue is swelling a bit that she cannot see the uvula when she opens her mouth), URTICARIA (hives around her neck), BODY TEMPERATURE INCREASED (body temperature is now 100 degrees Fahrenheit) and NAUSEA (A bit nauseous) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 040C21A) for COVID-19 vaccination. 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 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced SWOLLEN TONGUE (tongue is swelling a bit that she cannot see the uvula when she opens her mouth), URTICARIA (hives around her neck), BODY TEMPERATURE INCREASED (body temperature is now 100 degrees Fahrenheit) and NAUSEA (A bit nauseous). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (tongue is swelling a bit that she cannot see the uvula when she opens her mouth) had not resolved and URTICARIA (hives around her neck), BODY TEMPERATURE INCREASED (body temperature is now 100 degrees Fahrenheit) and NAUSEA (A bit nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degrees fahrenheit (High) 100 degrees Fahrenheit. No concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1740056
Sex: F
Age: 59
State: NC

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/28/2021
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: Light in the chest; Lump in the throat; Tachycardia; Dizziness; Her doctor recommended her to delay the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness) and OFF LABEL USE (Her doctor recommended her to delay the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The patient's past medical history included Cancer (Patient had cancer 10 year ago.). Concomitant products included METOPROLOL SUCCINATE for Blood pressure, MELATONIN for Sleep disorder, THYROID (ARMOUR THYROID) for Thyroid disorder. On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced OFF LABEL USE (Her doctor recommended her to delay the vaccine). On 18-Sep-2021, the patient experienced CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia) and DIZZINESS (Dizziness). On 15-Sep-2021, OFF LABEL USE (Her doctor recommended her to delay the vaccine) had resolved. At the time of the report, CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia) and DIZZINESS (Dizziness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On the night of the 17sep2021 Patient took wells sleep tea for Sleeping aid. No concomitant medications was provided by the reporter. No treatment was provided by the reporter. This case was linked to MOD-2021-323073 (Patient Link).

Other Meds: METOPROLOL SUCCINATE; ARMOUR THYROID; MELATONIN

Current Illness:

ID: 1740057
Sex: M
Age:
State:

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

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

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

Allergies:

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

Symptoms: got a 104 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (got a 104 fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (got a 104 fever). At the time of the report, PYREXIA (got a 104 fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) Fever. No relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1740058
Sex: M
Age: 36
State: AZ

Vax Date: 04/29/2021
Onset Date: 05/28/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Name: sinuses with a CT scan; Result Unstructured Data: sinuses with a CT scan- fine; Test Name: ear test; Result Unstructured Data: normal; Test Name: MRI of the brain; Result Unstructured Data: normal; Test Name: eye test; Result Unstructured Data: normal

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: difficult to sleep/doesnot sleep; I can't work; headaches/strong headaches; dizzy; pain in my eyes/it hurts inside the eyes; feels like something is pressuring from inside at the sides and the back of the head; bothered by light/bothered by anything that shines; sensation of not feeling well; body aches; felt tired; felt like when someone gets the flue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like when someone gets the flue), DIZZINESS (dizzy), EYE PAIN (pain in my eyes/it hurts inside the eyes), HEAD DISCOMFORT (feels like something is pressuring from inside at the sides and the back of the head) and PHOTOPHOBIA (bothered by light/bothered by anything that shines) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included PANTOPRAZOLE for an unknown indication. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like when someone gets the flue) and MYALGIA (body aches). 28-May-2021, the patient experienced FATIGUE (felt tired). On 02-Jun-2021, the patient experienced DIZZINESS (dizzy), EYE PAIN (pain in my eyes/it hurts inside the eyes), HEAD DISCOMFORT (feels like something is pressuring from inside at the sides and the back of the head), PHOTOPHOBIA (bothered by light/bothered by anything that shines), MALAISE (sensation of not feeling well) and HEADACHE (headaches/strong headaches). On an unknown date, the patient experienced INSOMNIA (difficult to sleep/doesnot sleep) and IMPAIRED WORK ABILITY (I can't work). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency; GABAPENTIN for Pain, at a dose of 100 milligram three times a day; FLUOXETINE at a dose of 10 mg in the morning and AMITRIPTYLINE for Adverse event, at a dose of 50 mg once a day. On 29-May-2021, INFLUENZA LIKE ILLNESS (felt like when someone gets the flue), MYALGIA (body aches) and FATIGUE (felt tired) had resolved. At the time of the report, DIZZINESS (dizzy), EYE PAIN (pain in my eyes/it hurts inside the eyes), HEAD DISCOMFORT (feels like something is pressuring from inside at the sides and the back of the head), PHOTOPHOBIA (bothered by light/bothered by anything that shines), MALAISE (sensation of not feeling well), INSOMNIA (difficult to sleep/doesnot sleep), IMPAIRED WORK ABILITY (I can't work) and HEADACHE (headaches/strong headaches) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: normal (normal) sinuses with a CT scan- fine. On an unknown date, Ear, nose and throat examination: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: normal (normal) normal. On an unknown date, Ophthalmological examination: normal (normal) normal. This case was linked to MOD-2021-322837 (Patient Link).

Other Meds: PANTOPRAZOLE

Current Illness:

ID: 1740059
Sex: F
Age: 23
State: IL

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 09/28/2021
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: sore throat since/not a common sore throat; swallows; breathe too deep; diagnosed with acid reflux; felt like a baby landed on her chest/ she can taste or feel her throat; tension on her left arm; she can not take a forward breathe when try to breathe; slight headache; arm was sore from the shoulder down; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (diagnosed with acid reflux), FEELING ABNORMAL (felt like a baby landed on her chest/ she can taste or feel her throat), MUSCLE TIGHTNESS (tension on her left arm), DYSPNOEA (she can not take a forward breathe when try to breathe) and OROPHARYNGEAL PAIN (sore throat since/not a common sore throat) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Disorder thyroid (abnormal thyroid and hormones levels which are now normal.) and Hormone level abnormal. On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced FEELING ABNORMAL (felt like a baby landed on her chest/ she can taste or feel her throat), MUSCLE TIGHTNESS (tension on her left arm), DYSPNOEA (she can not take a forward breathe when try to breathe), HEADACHE (slight headache) and VACCINATION SITE PAIN (arm was sore from the shoulder down). On 12-Sep-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (diagnosed with acid reflux). On 17-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat since/not a common sore throat), DYSPHAGIA (swallows) and HYPERVENTILATION (breathe too deep). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (diagnosed with acid reflux), FEELING ABNORMAL (felt like a baby landed on her chest/ she can taste or feel her throat), MUSCLE TIGHTNESS (tension on her left arm), DYSPNOEA (she can not take a forward breathe when try to breathe), OROPHARYNGEAL PAIN (sore throat since/not a common sore throat), DYSPHAGIA (swallows), HYPERVENTILATION (breathe too deep), HEADACHE (slight headache) and VACCINATION SITE PAIN (arm was sore from the shoulder down) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product was not provided by the reporter. patient reported that she experienced baby landed on her chest, had tension on her left arm, her arm was sore from the shoulder down and she had a slight headache. Patient went to emergency room On 12-Sep-2021 to 13-Sep-2021. she diagnosed with acid reflux. on Friday night, 17Sept2021,she had a sore throat. Treatment information was not provided. Company Comment: This case concerns a 23-year-old female subject with no reported relevant medical history, who experienced the unexpected non-serious events of gastrooesophageal reflux disease, muscle tightness, dyspnoea, oropharyngeal pain, dysphagia and hyperventilation. The rechallenge was unknown. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Based on information available and as per medical criteria events were classified as Non-serious.; Sender's Comments: This case concerns a 23-year-old female subject with no reported relevant medical history, who experienced the unexpected non-serious events of gastrooesophageal reflux disease, muscle tightness, dyspnoea, oropharyngeal pain, dysphagia and hyperventilation. The rechallenge was unknown. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Based on information available and as per medical criteria events were classified as Non-serious.

Other Meds:

Current Illness:

ID: 1740060
Sex: F
Age: 57
State:

Vax Date: 09/14/2021
Onset Date: 09/16/2021
Rec V Date: 09/28/2021
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: This spontaneous case reported by a consumer, describes the occurrence of dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 050E21A) for COVID-19 immunization. No medical history reported. On Sep 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 16, 2021, patient experienced dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain). At the time of the report, dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information provided.

Other Meds:

Current Illness:

ID: 1740061
Sex: F
Age: 40
State: PA

Vax Date: 09/10/2021
Onset Date: 09/19/2021
Rec V Date: 09/28/2021
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: period delayed for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (period delayed for 4 days) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergic to Sulfa). On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, the patient experienced MENSTRUATION DELAYED (period delayed for 4 days). At the time of the report, MENSTRUATION DELAYED (period delayed for 4 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitants medication were provided. No treatment medication were provided. Second dose is scheduled on 8-Oct-2021.

Other Meds:

Current Illness: Drug allergy (Allergic to Sulfa)

ID: 1740062
Sex: F
Age: 49
State: NC

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: high; Test Date: 20210917; Test Name: Blood pressure; Result Unstructured Data: Patient unsure of the exact measurement; Test Date: 20210918; Test Name: Blood pressure; Result Unstructured Data: high; Test Date: 20210918; Test Name: Blood pressure; Result Unstructured Data: blood pressure was slightly lower than before at 144/80; Test Date: 20210918; Test Name: Electrocardiogram; Result Unstructured Data: heart was fine; Test Date: 20210827; Test Name: pain scale; Test Result: Inconclusive ; Result Unstructured Data: 7/10

Allergies:

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

Symptoms: left eye started jumping; blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90; severe headache with a pain scale of 7/10/ intermittent headache; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (left eye started jumping), HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90) and HEADACHE (severe headache with a pain scale of 7/10/ intermittent headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Concurrent medical conditions included Uterine fibroids (Gigantic uterine fibroids with a size of a 14th week pregnancy was also noted.) and Drug allergy. Concomitant products included LISINOPRIL (LISINOPRIL ACTAVIS [LISINOPRIL]), LINACLOTIDE (LINZESS), SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), VITAMIN C [ASCORBIC ACID], CALCIUM, MAGNESIUM, ZINC and VITAMIN D3 for an unknown indication. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced HEADACHE (severe headache with a pain scale of 7/10/ intermittent headache). On 17-Sep-2021, the patient experienced BLEPHAROSPASM (left eye started jumping) and HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 dosage form (2 Tylenol ) and NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form (1 Aleve). At the time of the report, BLEPHAROSPASM (left eye started jumping), HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90) and HEADACHE (severe headache with a pain scale of 7/10/ intermittent headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Pain assessment: 7/10 (Inconclusive) 7/10. On 17-Sep-2021, Blood pressure measurement: 170/100 (High) Patient unsure of the exact measurement. On 18-Sep-2021, Blood pressure measurement: 165/95 (High) high and 144/80 (abnormal) blood pressure was slightly lower than before at 144/80. On 18-Sep-2021, Electrocardiogram: normal (normal) heart was fine. On an unknown date, Blood pressure measurement: 186/90 (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was allergic to powder and latex gloves Patient was put on blood pressure medication. Gigantic uterine fibroids with a size of a 14th week pregnancy was also noted.

Other Meds: LISINOPRIL ACTAVIS [LISINOPRIL]; LINZESS; ELDERBERRY [SAMBUCUS NIGRA FRUIT]; VITAMIN C [ASCORBIC ACID]; CALCIUM; MAGNESIUM; ZINC; VITAMIN D3

Current Illness: Drug allergy; Uterine fibroids (Gigantic uterine fibroids with a size of a 14th week pregnancy was also noted.)

ID: 1740063
Sex: F
Age: 69
State: WA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Date: 20210113; Test Name: Temperature; Result Unstructured Data: 100

Allergies:

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

Symptoms: dizziness; Could not lift head off pillow; very sore arm/arm pain; Headache; Vomited; fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache) and VOMITING (Vomited) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma, Bronchiectasis, Allergy to antibiotic (allergy to vancomycin) and Allergy to plants (allergy to Echinacea). On 11-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache), VOMITING (Vomited), PYREXIA (fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache), VOMITING (Vomited), PYREXIA (fever) and FATIGUE (Tiredness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 100 (High) 100. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications reported. The patient slept for 2 days, rested and self hydrated for treatment. This case was linked to MOD-2021-323632, MOD-2021-310473 (Patient Link).

Other Meds:

Current Illness: Allergy to antibiotic (allergy to vancomycin); Allergy to plants (allergy to Echinacea); Asthma; Bronchiectasis

ID: 1740064
Sex: F
Age: 75
State: CA

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 09/28/2021
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: had a sore arm(For the first 2 doses); This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (had a sore arm(For the first 2 doses)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 031M20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Drug hypersensitivity (Gabapentin makes patient nauseated and have vertigo), Asthma (underlying asthma which is usually in control) and Autoimmune disorder NOS. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication. On 07-Jan-2021, 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 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a sore arm(For the first 2 doses)). At the time of the report, PAIN IN EXTREMITY (had a sore arm(For the first 2 doses)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. For the first 2 doses, patient had no trouble at all, only had a sore arm that went away after a fewdays.

Other Meds: ADVAIR

Current Illness: Asthma (underlying asthma which is usually in control); Autoimmune disorder NOS; Drug hypersensitivity (Gabapentin makes patient nauseated and have vertigo)

Date Died:

ID: 1740065
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
Hospital: Y

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: Multiple heart attack patients (4 to 5); 2 people died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (2 people died) and MYOCARDIAL INFARCTION (Multiple heart attack patients (4 to 5)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (2 people died) (seriousness criteria death and medically significant) and MYOCARDIAL INFARCTION (Multiple heart attack patients (4 to 5)) (seriousness criteria hospitalization and medically significant). 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, MYOCARDIAL INFARCTION (Multiple heart attack patients (4 to 5)) outcome was unknown. Concomitant medications were not reported. Multiple people had heart attacks after vaccine. Two people died after getting the COVID-19 vaccine. Treatment information was not provided. Company Comment: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected events of myocardial infarction and death. Cause of death was unknown. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-323668, MOD21-144997 (Patient Link).; Sender's Comments: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected events of myocardial infarction and death. Cause of death was unknown. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1740066
Sex: F
Age:
State: PA

Vax Date: 03/26/2021
Onset Date: 04/01/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Hollow Talk; Loss of hearing after the second Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included BUDESONIDE for Colitis, WARFARIN SODIUM (COUMADIN) for Seizures, VITAMINS NOS, PROBIOTICS NOS, CLONAZEPAM and MONTELUKAST for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-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 DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination). At the time of the report, DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination) outcome was unknown. Concomitant medication includes Lobotrixine, Totermine, Antrictalis. Treatment information was not provided. Doctor tell her that there was nothing wrong whit her ears.

Other Meds: VITAMINS NOS; PROBIOTICS NOS; COUMADIN; CLONAZEPAM; MONTELUKAST; BUDESONIDE

Current Illness:

ID: 1740067
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: stomach pain; upset stomach; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. No concomitant medication information were provided. No treatment information were provided.

Other Meds:

Current Illness:

ID: 1740068
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: "I took my vaccine and I had chills."; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ("I took my vaccine and I had chills.") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS ("I took my vaccine and I had chills."). At the time of the report, CHILLS ("I took my vaccine and I had chills.") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1740069
Sex: M
Age: 74
State: CA

Vax Date: 01/01/2021
Onset Date: 09/04/2021
Rec V Date: 09/28/2021
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: Shingles 3 months after vaccination; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Shingles 3 months after vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024L20A and 025021) for COVID-19 vaccination. The patient's past medical history included Lymphoma (Patient was on Chemotherapy for approximately 5 months.). Concurrent medical conditions included Immunocompromised. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced HERPES ZOSTER (Shingles 3 months after vaccination). At the time of the report, HERPES ZOSTER (Shingles 3 months after vaccination) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness: Immunocompromised

ID: 1740070
Sex: M
Age: 49
State: CA

Vax Date: 02/13/2021
Onset Date: 03/13/2021
Rec V Date: 09/28/2021
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: sore arm; pain at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (pain at injection site) and CHILLS (Chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination. The patient had no known allergies. The patient's past medical history included Vasectomy. Concomitant products included FISH OIL (FISH OIL OMEGA 3), ROSUVASTATIN, NIACIN, ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (pain at injection site) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of 800 mg. At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (pain at injection site) and CHILLS (Chills) outcome was unknown. As treatment the patient also used cold compress. This case was linked to MOD-2021-323843.

Other Meds: FISH OIL OMEGA 3; ROSUVASTATIN; NIACIN; ASPIRIN [ACETYLSALICYLIC ACID]; B12 [CYANOCOBALAMIN]; VITAMIN D [VITAMIN D NOS]

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am