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: 1707509
Sex: F
Age: 45
State: MN

Vax Date: 08/06/2021
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210908; Test Name: Blood test; Result Unstructured Data: normal; Test Date: 20210908; Test Name: heart; Result Unstructured Data: normal

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Had a hot and cold feeling; Had a hot and cold feeling; Left arm was throbbing; Feeling was scary/Feels like she was hit by a truck; Fainted; Room became dizzy; left arm was throbbing; Experienced burning in the chest; Headache; Nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BURNING SENSATION (Experienced burning in the chest), HEADACHE (Headache) and NAUSEA (Nauseousness). On 08-Sep-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), DIZZINESS (Room became dizzy), FEELING HOT (Had a hot and cold feeling), FEELING COLD (Had a hot and cold feeling), PAIN (Left arm was throbbing), FEELING ABNORMAL (Feeling was scary/Feels like she was hit by a truck) and VACCINATION SITE PAIN (left arm was throbbing). At the time of the report, SYNCOPE (Fainted), DIZZINESS (Room became dizzy), BURNING SENSATION (Experienced burning in the chest), FEELING HOT (Had a hot and cold feeling), FEELING COLD (Had a hot and cold feeling), PAIN (Left arm was throbbing), FEELING ABNORMAL (Feeling was scary/Feels like she was hit by a truck), HEADACHE (Headache), NAUSEA (Nauseousness) and VACCINATION SITE PAIN (left arm was throbbing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Blood test: normal (normal) normal. On 08-Sep-2021, Heart rate: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Lab investigation includes tests, heart monitoring and took blood and test results came back normal. On 08-Sep-2021 patient had an annual mammogram scheduled at local hospital and she fainted during mammogram. No concomitant medication was provided by the reporter. No treatment information was provided by the reporter. This case concerns a 45-year-old, male patient with no relevant medical history. The patient experience burning sensation, headache and nausea 1 month 2 days and, syncope, dizziness, pain in extremity ,feeling hot , feeling cold , pain , and feeling abnormal 1 month 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report. This case was linked to MOD-2021-312925 (Patient Link).; Sender's Comments: This case concerns a 45-year-old, male patient with no relevant medical history. The patient experience burning sensation, headache and nausea 1 month 2 days and, syncope, dizziness, pain in extremity ,feeling hot , feeling cold , pain , and feeling abnormal 1 month 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.

Other Meds:

Current Illness:

ID: 1707510
Sex: F
Age: 62
State: NJ

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 09/17/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was provided by the reporter. No treatment medications were reported. This case was linked to MOD-2021-313036, MOD-2021-313035 (Patient Link).

Other Meds:

Current Illness:

ID: 1707511
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Running fever since; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Running fever since) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Running fever since). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PYREXIA (Running fever since) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not reported by reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707512
Sex: F
Age:
State:

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness) 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 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness). At the time of the report, PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness) had resolved. It was stated although it was not the official prescribed time for the vaccination we decided to set up the appointment anyway and we had no problem doing so and received the third shot. Mentioned as of today we were both fine and feel a bit more protected. Concomitant medication was not reported.Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1707513
Sex: F
Age:
State:

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
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: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: NEGATIVE

Allergies:

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

Symptoms: Extremely sick; Heart racing; Very bad sore throat; Very bad cough; Lymph nodes are swollen; Very fatigued; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough) and LYMPHADENOPATHY (Lymph nodes are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm). At the time of the report, ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) NEGATIVE. 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: 1707514
Sex: M
Age: 59
State: AL

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

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

Lab Data: Test Date: 09/07/2021; Test Name: Body temperature; Result Unstructured Data: Body temperature 101.2?F.

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever 101.2?F) and myalgia (muscle pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 002F21A) for COVID-19 immunization. No medical history reported. On Aug 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 7, 2021, patient experienced pyrexia (fever 101.2?F) and myalgia (muscle pain). At the time of the report, pyrexia (fever 101.2?F) and myalgia (muscle pain) outcome unknown. Diagnostic results: On Sep 7, 2021: Body temperature 101.2?F (high). The patient's concomitant medications included multivitamins. No treatment medications provided.

Other Meds:

Current Illness:

ID: 1707515
Sex: F
Age: 65
State: SC

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/17/2021
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: been very itchy at the injection site; stomach cramps; diarrhea; a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents; fever; arm hurt a lot; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (been very itchy at the injection site), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), VACCINATION SITE MASS (a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (been very itchy at the injection site), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), VACCINATION SITE MASS (a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents), PYREXIA (fever), PAIN IN EXTREMITY (arm hurt a lot) and FATIGUE (very tired). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 01-Sep-2021, PYREXIA (fever) had resolved. On 04-Sep-2021, FATIGUE (very tired) had resolved. On 08-Sep-2021, ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea) had resolved. At the time of the report, VACCINATION SITE PRURITUS (been very itchy at the injection site), VACCINATION SITE MASS (a huge lump which is hard/lump was large as a silver dollar and now its the size of 50 cents) and PAIN IN EXTREMITY (arm hurt a lot) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reportedly, Patient was not allergic to anything. Patient states that she possibly had been exposed to COVID-19 in Feb2020 Patient gave SO consent to follow up with vaccination site and HCP. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1707516
Sex: F
Age: 51
State: TX

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/17/2021
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: Feeling very sick; Dizziness; Remaining head droning/puffing in her head; COVID19-like symptoms; Anxiety; Head pounding; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling very sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Remaining head droning/puffing in her head), SUSPECTED COVID-19 (COVID19-like symptoms) and ANXIETY (Anxiety) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in April 2021. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced MALAISE (Feeling very sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Remaining head droning/puffing in her head), SUSPECTED COVID-19 (COVID19-like symptoms), ANXIETY (Anxiety), HEADACHE (Head pounding), FATIGUE (Fatigue) and NAUSEA (Nausea). On 26-Aug-2021, MALAISE (Feeling very sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Remaining head droning/puffing in her head), SUSPECTED COVID-19 (COVID19-like symptoms), ANXIETY (Anxiety), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved and HEADACHE (Head pounding) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was reported by reporter. Reporter said she had COVID-19 positive 5 months ago and experienced post-covid symptoms for 5 months.

Other Meds:

Current Illness:

ID: 1707517
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 09/17/2021
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: had quite a bit of arm pain; aches for about 24 hrs.; experience tireness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches for about 24 hrs.), FATIGUE (experience tireness) and PAIN IN EXTREMITY (had quite a bit of arm pain) 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 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-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 MYALGIA (aches for about 24 hrs.), FATIGUE (experience tireness) and PAIN IN EXTREMITY (had quite a bit of arm pain). At the time of the report, MYALGIA (aches for about 24 hrs.), FATIGUE (experience tireness) and PAIN IN EXTREMITY (had quite a bit of arm pain) had resolved. No concomitant medications were reported by reporter Treatment information was not provided. This case was linked to MOD-2021-312981 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707518
Sex: F
Age: 52
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: brain was not connecting to her eyelids or other parts of her body; hallucinating; trouble controlling her eyelids; motor skills issues with things like typing; slurred speech; memory issues; legs felt like Jello; hadn't eaten; pain in the left side of her neck; light pressure on her chest; felt like she was really drunk minus the fun part; burping; sweating; freezing; blurred vision; tension headache; problems concentrating; was not doing well; body aches; felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (brain was not connecting to her eyelids or other parts of her body) and HALLUCINATION (hallucinating) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic fatigue and Fibromyalgia. Concomitant products included OXYCODONE for an unknown indication. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced MENTAL IMPAIRMENT (brain was not connecting to her eyelids or other parts of her body) (seriousness criterion medically significant), HALLUCINATION (hallucinating) (seriousness criterion medically significant), EYELID FUNCTION DISORDER (trouble controlling her eyelids), MOBILITY DECREASED (motor skills issues with things like typing), DYSARTHRIA (slurred speech), MEMORY IMPAIRMENT (memory issues), LIMB DISCOMFORT (legs felt like Jello), HYPOPHAGIA (hadn't eaten), NECK PAIN (pain in the left side of her neck), CHEST DISCOMFORT (light pressure on her chest), FEELING ABNORMAL (felt like she was really drunk minus the fun part), ERUCTATION (burping), HYPERHIDROSIS (sweating), FREEZING PHENOMENON (freezing), VISION BLURRED (blurred vision), TENSION HEADACHE (tension headache), DISTURBANCE IN ATTENTION (problems concentrating), MALAISE (was not doing well), MYALGIA (body aches) and NAUSEA (felt nauseous). At the time of the report, MENTAL IMPAIRMENT (brain was not connecting to her eyelids or other parts of her body), HALLUCINATION (hallucinating), EYELID FUNCTION DISORDER (trouble controlling her eyelids), MOBILITY DECREASED (motor skills issues with things like typing), DYSARTHRIA (slurred speech), MEMORY IMPAIRMENT (memory issues), LIMB DISCOMFORT (legs felt like Jello), HYPOPHAGIA (hadn't eaten), NECK PAIN (pain in the left side of her neck), CHEST DISCOMFORT (light pressure on her chest), FEELING ABNORMAL (felt like she was really drunk minus the fun part), ERUCTATION (burping), HYPERHIDROSIS (sweating), FREEZING PHENOMENON (freezing), VISION BLURRED (blurred vision), TENSION HEADACHE (tension headache), DISTURBANCE IN ATTENTION (problems concentrating), MALAISE (was not doing well), MYALGIA (body aches) and NAUSEA (felt nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided by the reporter Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded

Other Meds: OXYCODONE

Current Illness: Chronic fatigue; Fibromyalgia

ID: 1707519
Sex: F
Age: 82
State: CA

Vax Date: 08/06/2021
Onset Date: 09/04/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: felt like she should go to bed and sleep; vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting; nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting; extreme fatigue which made her so tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt like she should go to bed and sleep), VOMITING (vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting), NAUSEA (nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) and FATIGUE (extreme fatigue which made her so tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 078C21A) for COVID-19 vaccination. Concurrent medical conditions included Cerebellar ataxia (neurological condition). On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced SOMNOLENCE (felt like she should go to bed and sleep). 04-Sep-2021, the patient experienced VOMITING (vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting), NAUSEA (nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) and FATIGUE (extreme fatigue which made her so tired). At the time of the report, SOMNOLENCE (felt like she should go to bed and sleep) and FATIGUE (extreme fatigue which made her so tired) outcome was unknown and VOMITING (vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) and NAUSEA (nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) had not resolved. Concomitant medications were not reported No treatment information was provided. On 04-Sep-2021, The patient developed some side effects, including nausea, vomiting and extreme fatigue which made her so tired and felt like she should go to bed and sleep. On 04-Sep-2021 and 05-Sep-2021, The patient tried to eat a little bit but could not keep it down in her stomach due to bad nausea and vomiting. On 06-Sep-2021 and 07-Sep-2021, The patient could eat a little and could keep it down. On 08-Sep-2021, Morning after having tea with breakfast patient felt nauseated and felt like vomiting.

Other Meds:

Current Illness: Cerebellar ataxia (neurological condition)

ID: 1707520
Sex: M
Age: 82
State: NV

Vax Date: 09/03/2021
Onset Date: 09/04/2021
Rec V Date: 09/17/2021
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: stomach irritation pain; worsening stomach problems; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach irritation pain) and CONDITION AGGRAVATED (worsening stomach problems) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Stomach cancer and Unspecified functional disorder of stomach (Stomach problems). Concomitant products included OMEPRAZOLE and SUCRALFATE for an unknown indication. On 03-Sep-2021, the patient 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 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 04-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach irritation pain) and CONDITION AGGRAVATED (worsening stomach problems). On 05-Sep-2021, ABDOMINAL PAIN UPPER (stomach irritation pain) and CONDITION AGGRAVATED (worsening stomach problems) had resolved. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up document contains no new information.

Other Meds: OMEPRAZOLE; SUCRALFATE

Current Illness: Stomach cancer; Unspecified functional disorder of stomach (Stomach problems)

ID: 1707521
Sex: F
Age: 62
State: NJ

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 09/17/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. Relevant concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-312975, MOD-2021-313035 (Patient Link).

Other Meds:

Current Illness:

ID: 1707522
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Only site of injection pain.; We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (Only site of injection pain.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered) 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 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered). On an unknown date, the patient experienced VACCINATION SITE PAIN (Only site of injection pain.). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered) had resolved. At the time of the report, VACCINATION SITE PAIN (Only site of injection pain.) had resolved. No concomitant product use was provided by the reporter. No treatment medications were reported. During the time of reporting, the reporter stated that her husband is fine.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-141325:Wife case

Other Meds:

Current Illness:

ID: 1707523
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) in an 83-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Severe headache) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1707524
Sex: F
Age: 39
State: TX

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 09/17/2021
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: Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily; She had burning in nose.; She could taste chemical in her mouth.; She started with immediate burning and pain at injection site.; She had mild fatigue on same day and following day after 1st dose and 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) and FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1088021A) for COVID-19 vaccination. No medical history was provided. Concomitant products included VITAMINS NOS and IRON for an unknown indication. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) and FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), NASAL DISCOMFORT (She had burning in nose.) and DYSGEUSIA (She could taste chemical in her mouth.). At the time of the report, HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily) had not resolved and NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) and FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment provided as birth control. This case was linked to MOD-2021-313162 (Patient Link).

Other Meds: VITAMINS NOS; IRON

Current Illness:

ID: 1707525
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Severe nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Severe nerve pain ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (Severe nerve pain ). At the time of the report, NEURALGIA (Severe nerve pain ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was reported by reporter.

Other Meds:

Current Illness:

ID: 1707526
Sex: F
Age: 58
State: TN

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
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: Memory loss/Ask her a question, she does not remember the answer; Feels like a headache is coming but it is not but she does not have a headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss/Ask her a question, she does not remember the answer ), FEELING ABNORMAL (Feels like a headache is coming but it is not but she does not have a headache) and MYALGIA (Sore Arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. 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 AMNESIA (Memory loss/Ask her a question, she does not remember the answer ), FEELING ABNORMAL (Feels like a headache is coming but it is not but she does not have a headache) and MYALGIA (Sore Arm). At the time of the report, AMNESIA (Memory loss/Ask her a question, she does not remember the answer ), FEELING ABNORMAL (Feels like a headache is coming but it is not but she does not have a headache) and MYALGIA (Sore Arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reportedly, patient did not feel tired or fatigued. Patient's consent to follow-up was affirmative. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1707527
Sex: M
Age: 77
State:

Vax Date: 09/03/2021
Onset Date: 09/04/2021
Rec V Date: 09/17/2021
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: Little pressure in my chest; Pressure in my eyes; Sweats,Perspiration; Anxiety; Really wired; Difficulty Sleeping; Chills; Hot flashes; Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), HOT FLUSH (Hot flashes), CHEST DISCOMFORT (Little pressure in my chest), OCULAR DISCOMFORT (Pressure in my eyes) and HYPERHIDROSIS (Sweats,Perspiration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). On 05-Sep-2021, the patient experienced HOT FLUSH (Hot flashes), OCULAR DISCOMFORT (Pressure in my eyes), HYPERHIDROSIS (Sweats,Perspiration), ANXIETY (Anxiety), FEELING ABNORMAL (Really wired), INSOMNIA (Difficulty Sleeping) and CHILLS (Chills). On 08-Sep-2021, the patient experienced CHEST DISCOMFORT (Little pressure in my chest). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 08-Sep-2021, HOT FLUSH (Hot flashes) had resolved. At the time of the report, DIARRHOEA (Diarrhea), CHEST DISCOMFORT (Little pressure in my chest), OCULAR DISCOMFORT (Pressure in my eyes), HYPERHIDROSIS (Sweats,Perspiration), ANXIETY (Anxiety), FEELING ABNORMAL (Really wired), INSOMNIA (Difficulty Sleeping) and CHILLS (Chills) outcome was unknown. No Concomitant medications was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707528
Sex: F
Age: 53
State: AK

Vax Date: 08/19/2021
Onset Date: 08/21/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: It caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit; It wasnot a normal cycle; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (it caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit) and MENSTRUAL DISORDER (it wasn't a normal cycle) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (it caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit) and MENSTRUAL DISORDER (it wasn't a normal cycle). On 25-Aug-2021, INTERMENSTRUAL BLEEDING (it caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit) and MENSTRUAL DISORDER (it wasn't a normal cycle) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications are provided. Treatment to the events not reported. Patient was due for her menstrual cycle on 03-Sep-2021, but that never happened, she is still not in menopause. Patient schedule second dose on 16-sep-2021.

Other Meds:

Current Illness:

ID: 1707529
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: Immediate allergic reaction; First dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Immediate allergic reaction) and PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago) 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. In January 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 ALLERGY TO VACCINE (Immediate allergic reaction) and PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago). At the time of the report, ALLERGY TO VACCINE (Immediate allergic reaction) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was provided by the reporter. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1707530
Sex: F
Age: 48
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: She felt very hot then she felt very cold; Temperature like she has a fever; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (She felt very hot then she felt very cold), HEADACHE (Terrible headache) and PYREXIA (Temperature like she has a fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced HEADACHE (Terrible headache). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (She felt very hot then she felt very cold) and PYREXIA (Temperature like she has a fever). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (She felt very hot then she felt very cold), HEADACHE (Terrible headache) and PYREXIA (Temperature like she has a fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter said patient taking other medications. No treatment information was reported by reporter.

Other Meds:

Current Illness:

ID: 1707531
Sex: M
Age: 33
State: CA

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 09/17/2021
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: having trouble breathing; breathing problems are getting worse every day; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having trouble breathing) and CONDITION AGGRAVATED (breathing problems are getting worse every day) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 13-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 DYSPNOEA (having trouble breathing) and CONDITION AGGRAVATED (breathing problems are getting worse every day). At the time of the report, DYSPNOEA (having trouble breathing) and CONDITION AGGRAVATED (breathing problems are getting worse every day) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not reported by reporter Treatment information was not provided by reporter

Other Meds:

Current Illness:

ID: 1707532
Sex: M
Age: 49
State: TX

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/17/2021
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: Felt faint in the shower; Very tired after first vaccine; Injection site left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint in the shower), FATIGUE (Very tired after first vaccine) and VACCINATION SITE PAIN (Injection site left arm was sore) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DIZZINESS (Felt faint in the shower), FATIGUE (Very tired after first vaccine) and VACCINATION SITE PAIN (Injection site left arm was sore). At the time of the report, DIZZINESS (Felt faint in the shower), FATIGUE (Very tired after first vaccine) and VACCINATION SITE PAIN (Injection site left arm was sore) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Relevant concomitant medications were not reported. The treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707533
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Headache; 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 HEADACHE (Headache) 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1707534
Sex: U
Age:
State: DC

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

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

Lab Data:

Allergies:

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

Symptoms: administered beyond 30 day vaccine; 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 EXPIRED PRODUCT ADMINISTERED (administered beyond 30 day vaccine) 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 EXPIRED PRODUCT ADMINISTERED (administered beyond 30 day vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered beyond 30 day vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707535
Sex: M
Age: 75
State: AR

Vax Date: 07/30/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Body started changing a bit; Sore arm; Sex drive started increasing; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Body started changing a bit), PAIN IN EXTREMITY (Sore arm) and LIBIDO INCREASED (Sex drive started increasing) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Body started changing a bit), PAIN IN EXTREMITY (Sore arm) and LIBIDO INCREASED (Sex drive started increasing). At the time of the report, FEELING ABNORMAL (Body started changing a bit), PAIN IN EXTREMITY (Sore arm) and LIBIDO INCREASED (Sex drive started increasing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The consumer stated that he uses blood pressure medication. No treatment medications were reported. This case was linked to MOD-2021-313131 (Patient Link).

Other Meds:

Current Illness: Hypertension

ID: 1707536
Sex: F
Age: 58
State: WI

Vax Date: 08/08/2021
Onset Date:
Rec V Date: 09/17/2021
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: Mild general pain / pain in the body; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild general pain / pain in the body) and PAIN IN EXTREMITY (Pain in the arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Mild general pain / pain in the body) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, PAIN (Mild general pain / pain in the body) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications reported. No treatment information was reported by reporter. This case was linked to MOD-2021-313125 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707537
Sex: F
Age: 53
State: NC

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
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: They also said I had some inflammation of the liver.; I had a huge amount of swelling underneath & above both my eyelids.; right back pain that went into the right shoulder blade.; I had vomiting; I had nausea; The pain radiated around my side to my back.; I started feeling a dull pain on my right side, above rib cage.; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (They also said I had some inflammation of the liver.), SWELLING OF EYELID (I had a huge amount of swelling underneath & above both my eyelids.), BACK PAIN (The pain radiated around my side to my back.), PAIN (I started feeling a dull pain on my right side, above rib cage.), ARTHRALGIA (right back pain that went into the right shoulder blade.), VOMITING (I had vomiting) and NAUSEA (I had nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The patient's past medical history included Gilbert's syndrome (blood disorder) and Kidney stones. On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (The pain radiated around my side to my back.) (seriousness criterion medically significant) and PAIN (I started feeling a dull pain on my right side, above rib cage.) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced HEPATITIS (They also said I had some inflammation of the liver.) (seriousness criterion medically significant), SWELLING OF EYELID (I had a huge amount of swelling underneath & above both my eyelids.) (seriousness criterion medically significant), ARTHRALGIA (right back pain that went into the right shoulder blade.) (seriousness criterion medically significant), VOMITING (I had vomiting) (seriousness criterion medically significant) and NAUSEA (I had nausea) (seriousness criterion medically significant). At the time of the report, HEPATITIS (They also said I had some inflammation of the liver.), SWELLING OF EYELID (I had a huge amount of swelling underneath & above both my eyelids.), BACK PAIN (The pain radiated around my side to my back.), PAIN (I started feeling a dull pain on my right side, above rib cage.), ARTHRALGIA (right back pain that went into the right shoulder blade.), VOMITING (I had vomiting) and NAUSEA (I had nausea) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Concomitant medication information not provided. Treatment information not provided. Patient was not been to work in a year, due to car wreck. patient was to advised not to take another dose of the vaccine. Company Comment: The report concerns a 53 year old female patient with medical history of gilbert's syndrome and kidney stones who experienced serious unexpected events of radiating back pain, dull aching pain, swelling of the eyelid, arthralgia, hepatitis, vomiting and nausea after vaccination with first dose of mRNA-1273 on the same day. It was reported that the patient was advised not to take the second dose of the vaccine. The medical history of gilbert's syndrome remains a confounder for the reported events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: The report concerns a 53 year old female patient with medical history of gilbert's syndrome and kidney stones who experienced serious unexpected events of radiating back pain, dull aching pain, swelling of the eyelid, arthralgia, hepatitis, vomiting and nausea after vaccination with first dose of mRNA-1273 on the same day. It was reported that the patient was advised not to take the second dose of the vaccine. The medical history of gilbert's syndrome remains a confounder for the reported events. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1707538
Sex: M
Age: 61
State: TN

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Abnormal

Allergies:

Symptom List: Nausea

Symptoms: skin rash (felt like sandpaper); joint pain all over his body/knee pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH (skin rash (felt like sandpaper)) and ARTHRALGIA (joint pain all over his body/knee pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (skin rash (felt like sandpaper)) and ARTHRALGIA (joint pain all over his body/knee pain). At the time of the report, RASH (skin rash (felt like sandpaper)) and ARTHRALGIA (joint pain all over his body/knee pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not reported by reporter. It was reported that patient was kept on steroids and before the vaccine he had mild hip pain.

Other Meds:

Current Illness:

ID: 1707539
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: More than 42 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) had resolved. It was reported that caregiver was willing to know whether 92-year-old mother could get the second shot. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1707540
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: my left leg has been cramping ever since i got it; injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (my left leg has been cramping ever since i got it) and VACCINATION SITE PAIN (injection site is sore) 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 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced MUSCLE SPASMS (my left leg has been cramping ever since i got it) and VACCINATION SITE PAIN (injection site is sore). At the time of the report, MUSCLE SPASMS (my left leg has been cramping ever since i got it) and VACCINATION SITE PAIN (injection site is sore) outcome was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1707541
Sex: F
Age: 58
State: WI

Vax Date: 09/05/2021
Onset Date: 09/06/2021
Rec V Date: 09/17/2021
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: Back pain; Decreased appetite; chills; fever; Myalgia; General discomfort; Feeling hot; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General discomfort), FEELING HOT (Feeling hot), PAIN (Pain), BACK PAIN (Back pain) and DECREASED APPETITE (Decreased appetite) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced DISCOMFORT (General discomfort), FEELING HOT (Feeling hot), PAIN (Pain), DECREASED APPETITE (Decreased appetite), CHILLS (chills), PYREXIA (fever) and MYALGIA (Myalgia). On 07-Sep-2021, the patient experienced BACK PAIN (Back pain). On 07-Sep-2021, CHILLS (chills) and PYREXIA (fever) had resolved. On 08-Sep-2021, MYALGIA (Myalgia) had resolved. At the time of the report, DISCOMFORT (General discomfort), FEELING HOT (Feeling hot), PAIN (Pain), BACK PAIN (Back pain) and DECREASED APPETITE (Decreased appetite) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication use was reported. This case was linked to MOD-2021-313117 (Patient Link).

Other Meds:

Current Illness:

ID: 1707542
Sex: M
Age: 75
State: AR

Vax Date: 07/30/2021
Onset Date:
Rec V Date: 09/17/2021
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: body changed tremendously; sex drive increased tremendously; Certain parts of my body really came alive; things happened to my body that I never experienced before; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (body changed tremendously), LIBIDO INCREASED (sex drive increased tremendously), FEELING ABNORMAL (Certain parts of my body really came alive) and FEELING ABNORMAL (things happened to my body that I never experienced before) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 017C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Patient is only on blood pressure medication). On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-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 FEELING ABNORMAL (body changed tremendously), LIBIDO INCREASED (sex drive increased tremendously), FEELING ABNORMAL (Certain parts of my body really came alive) and FEELING ABNORMAL (things happened to my body that I never experienced before). At the time of the report, FEELING ABNORMAL (body changed tremendously), LIBIDO INCREASED (sex drive increased tremendously), FEELING ABNORMAL (Certain parts of my body really came alive) and FEELING ABNORMAL (things happened to my body that I never experienced before) outcome was unknown. Concomitant product use was reported as blood pressure medication was provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-313112 (Patient Link).

Other Meds:

Current Illness:

ID: 1707543
Sex: F
Age: 73
State: ME

Vax Date: 02/11/2021
Onset Date: 05/23/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: "woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose; woke up and right side of jaw was red; woke up and right side of jaw was hot; alergic reaction in the face; redness and numb.; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE ("woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose), ORAL MUCOSAL ERYTHEMA (woke up and right side of jaw was red), FEELING HOT (woke up and right side of jaw was hot), HYPERSENSITIVITY (alergic reaction in the face) and HYPOAESTHESIA (redness and numb.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination. Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced HYPERSENSITIVITY (alergic reaction in the face) and HYPOAESTHESIA (redness and numb.). On an unknown date, the patient experienced SWELLING FACE ("woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose), ORAL MUCOSAL ERYTHEMA (woke up and right side of jaw was red) and FEELING HOT (woke up and right side of jaw was hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, SWELLING FACE ("woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose), ORAL MUCOSAL ERYTHEMA (woke up and right side of jaw was red), FEELING HOT (woke up and right side of jaw was hot), HYPERSENSITIVITY (alergic reaction in the face) and HYPOAESTHESIA (redness and numb.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Significant follow-up received, events updated

Other Meds: DAILY VITAMINS

Current Illness:

ID: 1707544
Sex: F
Age: 21
State: SC

Vax Date: 08/09/2021
Onset Date: 09/06/2021
Rec V Date: 09/17/2021
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: movement reduced; vaccination site pain; Nauseous with smells of food.; Didn't really have an appetite/ She couldn't eat anything yesterday; Throat was dry; Couldn't breathe through my nose; Pain in my neck; Stomach was hurting too; Headache/ head is still hurting; Couldn't really move much; Legs would go numb; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Couldn't really move much), HYPOAESTHESIA (Legs would go numb), DECREASED APPETITE (Didn't really have an appetite/ She couldn't eat anything yesterday), DRY THROAT (Throat was dry) and DYSPNOEA (Couldn't breathe through my nose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03NF21A and 0H8B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced LIMB DISCOMFORT (Couldn't really move much), HYPOAESTHESIA (Legs would go numb), DRY THROAT (Throat was dry), DYSPNOEA (Couldn't breathe through my nose), NECK PAIN (Pain in my neck), ABDOMINAL PAIN UPPER (Stomach was hurting too) and HEADACHE (Headache/ head is still hurting). On 07-Sep-2021, the patient experienced DECREASED APPETITE (Didn't really have an appetite/ She couldn't eat anything yesterday) and NAUSEA (Nauseous with smells of food.). On an unknown date, the patient experienced HYPOKINESIA (movement reduced) and VACCINATION SITE PAIN (vaccination site pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (oral) at a dose of 400 mg. At the time of the report, LIMB DISCOMFORT (Couldn't really move much), HYPOAESTHESIA (Legs would go numb), DECREASED APPETITE (Didn't really have an appetite/ She couldn't eat anything yesterday), DRY THROAT (Throat was dry), DYSPNOEA (Couldn't breathe through my nose), NECK PAIN (Pain in my neck), ABDOMINAL PAIN UPPER (Stomach was hurting too), HYPOKINESIA (movement reduced), HEADACHE (Headache/ head is still hurting), NAUSEA (Nauseous with smells of food.) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown. Concomitant drug details not provided. On the night of 06Sep2021, she had a sore arm. She couldn't really move much because her legs would go numb. It lasted for 10 minutes. It would go away but then come back. She had headache. It felt like her brain was swelling. Her throat was dry, but it wasn't sore. She couldn't breathe through her nose, but it wasn't runny. She couldn't breathe no matter how much she tried to clean it. She had pain in her neck. If she lifted her head up, she would get another headache. Her stomach was hurting too. She felt nauseous with smells of food. She couldn't eat anything yesterday 07Sep2021; she didn't really have an appetite. Right now 08Sep2021 her head is still hurting a little bit and also the shot area Company Comment: Based on the current available information which includes a t temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Nausea, headache and myalgia are consistent with the product established safety profile.; Sender's Comments: Based on the current available information which includes a t temporal association between the use of the product and the start date of the reported events, a causal relationship with the events cannot be excluded. Nausea, headache and myalgia are consistent with the product established safety profile.

Other Meds:

Current Illness:

ID: 1707545
Sex: U
Age:
State:

Vax Date: 09/04/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: throat is swelling; shortness of breath; feeling like I need to vomit; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat is swelling), DYSPNOEA (shortness of breath) and VOMITING (feeling like I need to vomit) 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 04-Sep-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 PHARYNGEAL SWELLING (throat is swelling), DYSPNOEA (shortness of breath) and VOMITING (feeling like I need to vomit). At the time of the report, PHARYNGEAL SWELLING (throat is swelling), DYSPNOEA (shortness of breath) and VOMITING (feeling like I need to vomit) 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: 1707546
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: or has a little cold/he's a little cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (or has a little cold/he's a little cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetic. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (or has a little cold/he's a little cold). At the time of the report, NASOPHARYNGITIS (or has a little cold/he's a little cold) outcome was unknown. No Concomitant drugs were reported. No Treatment information were reported. The patient reported that, He doesn't know if he's immunocompromised and said he's a little bit immunocompromised Reporter did not allow further contact

Other Meds:

Current Illness: Diabetic

ID: 1707547
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Minimal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minimal side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Minimal side effects). At the time of the report, VACCINATION COMPLICATION (Minimal side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications was provided. No Treatment medications was provided.

Other Meds:

Current Illness:

ID: 1707548
Sex: F
Age: 63
State: NY

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 09/17/2021
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: Chronic pain in her neck which went away for a couple of weeks; 2nd shot not yet administered; Itching all over all over for a couple of days; Her lip looked wierd; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over all over for a couple of days), ORAL DISCOMFORT (Her lip looked wierd), NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (Itching all over all over for a couple of days) and ORAL DISCOMFORT (Her lip looked wierd). On an unknown date, the patient experienced NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered). On 01-Mar-2021, PRURITUS (Itching all over all over for a couple of days) outcome was unknown. At the time of the report, ORAL DISCOMFORT (Her lip looked wierd) and NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information was reported by reporter.

Other Meds:

Current Illness:

ID: 1707549
Sex: F
Age: 60
State: MO

Vax Date: 08/18/2021
Onset Date: 08/25/2021
Rec V Date: 09/17/2021
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: then they swell up, Some of them pop and look like sores, started having bumps on her left arm; it feels warm when it first starts; Patch on her side / a little red dot/spot,; new spots this morning, spreading in different places of her body. Front legs affected, back of legs affected, thighs affected, both arms affected, up to the shoulders are affected/ bumps on her left arm/ it's all over; some rash on stomach/ bumps on her left arm/ a little red dot/spot, then it starts swelling up and turn into red bumps/ Some of them start swelling up and pop into a little sores front and back of her leg, front and back of her thighs. Its all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Patch on her side / a little red dot/spot,), RASH MACULAR (new spots this morning, spreading in different places of her body. Front legs affected, back of legs affected, thighs affected, both arms affected, up to the shoulders are affected/ bumps on her left arm/ it's all over), SWELLING (then they swell up, Some of them pop and look like sores, started having bumps on her left arm), FEELING HOT (it feels warm when it first starts) and RASH (some rash on stomach/ bumps on her left arm/ a little red dot/spot, then it starts swelling up and turn into red bumps/ Some of them start swelling up and pop into a little sores front and back of her leg, front and back of her thighs. Its all over) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. Concomitant products included PHENTERMINE from 18-Aug-2021 to an unknown date for Dietary control. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced RASH MACULAR (new spots this morning, spreading in different places of her body. Front legs affected, back of legs affected, thighs affected, both arms affected, up to the shoulders are affected/ bumps on her left arm/ it's all over) and RASH (some rash on stomach/ bumps on her left arm/ a little red dot/spot, then it starts swelling up and turn into red bumps/ Some of them start swelling up and pop into a little sores front and back of her leg, front and back of her thighs. Its all over). On 26-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Patch on her side / a little red dot/spot,). On an unknown date, the patient experienced SWELLING (then they swell up, Some of them pop and look like sores, started having bumps on her left arm) and FEELING HOT (it feels warm when it first starts). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPO MEDROL) for Adverse event, at a dose of 1 dosage form; PREDNISONE for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Patch on her side / a little red dot/spot,), RASH MACULAR (new spots this morning, spreading in different places of her body. Front legs affected, back of legs affected, thighs affected, both arms affected, up to the shoulders are affected/ bumps on her left arm/ it's all over), SWELLING (then they swell up, Some of them pop and look like sores, started having bumps on her left arm), FEELING HOT (it feels warm when it first starts) and RASH (some rash on stomach/ bumps on her left arm/ a little red dot/spot, then it starts swelling up and turn into red bumps/ Some of them start swelling up and pop into a little sores front and back of her leg, front and back of her thighs. Its all over) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications included steroid and sinus drug. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow-up document received included events

Other Meds: PHENTERMINE

Current Illness:

ID: 1707550
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Experienced brain fog; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Experienced brain fog) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Experienced brain fog). At the time of the report, FEELING ABNORMAL (Experienced brain fog) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. It was reported that patient experienced brain fog four months ago. The treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707551
Sex: F
Age: 69
State: IL

Vax Date: 02/06/2021
Onset Date: 03/01/2021
Rec V Date: 09/17/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: increased

Allergies:

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

Symptoms: pericarditis; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and PERICARDITIS (pericarditis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 010M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 pneumonia (Patient was hospitalized for 2 nights starting 26-Nov-2020. ) on 15-Nov-2020 and Diverticulitis in November 2020. Concomitant products included FINASTERIDE for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Apr-2021 due to CHEST PAIN. The patient was treated with DILTIAZEM for Adverse event, at a dose of 60 mg; OMEPRAZOLE for Adverse event, at a dose of 40 mg; MULTIVITAMIN [VITAMINS NOS] for Adverse event, at an unspecified dose and frequency; CALCIUM for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN 81) for Adverse event, at a dose of 81 mg and ROSUVASTATIN for Adverse event, at a dose of 20 mg. At the time of the report, CHEST PAIN (chest pain) had not resolved and PERICARDITIS (pericarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (High) increased. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: FINASTERIDE

Current Illness:

ID: 1707552
Sex: M
Age: 76
State: GA

Vax Date: 04/28/2021
Onset Date: 05/19/2021
Rec V Date: 09/17/2021
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: could not make a fist with the right hand; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not make a fist with the right hand) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced MOBILITY DECREASED (could not make a fist with the right hand). At the time of the report, MOBILITY DECREASED (could not make a fist with the right hand) had not resolved. No relevant concomitant medications were reported. Treatment information was unknown. Reporter stated that if he exercised the right hand he was able to make a fist but if he did not use the right hand for a few minutes, he could not make a fist. This case was linked to MOD-2021-313220 (Patient Link).

Other Meds:

Current Illness:

ID: 1707553
Sex: F
Age: 70
State: AZ

Vax Date: 02/06/2021
Onset Date: 08/31/2021
Rec V Date: 09/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: headache; achiness; chills; a mild fever; received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised; some flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (some flu-like symptoms), HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD and Asthma. On 06-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 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (some flu-like symptoms) and OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised). On an unknown date, the patient experienced HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 31-Aug-2021, OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised) had resolved. On 01-Sep-2021, INFLUENZA LIKE ILLNESS (some flu-like symptoms) had resolved. At the time of the report, HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) outcome was unknown. Patient mentioned that her doctor's office did not say anything to her when they gave her the 3rd dose. She had some flu-like symptoms right after the 3rd dose. They lasted 24 hours and went away. She had the typical headache, achiness, chills, and a mild fever. She could not tell for sure if she had a fever since she did not have a thermometer. She slept and took acetaminophen. For 3rd dose lot number provided as 062E214 or 062E219. No concomitant medication was reported.

Other Meds:

Current Illness: Asthma; COPD

ID: 1707554
Sex: F
Age: 24
State: NY

Vax Date: 04/20/2021
Onset Date: 05/30/2021
Rec V Date: 09/17/2021
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: Pain in both arms/ pain in legs; Pain in upper and mid back; Pain in neck; Redness in left arm; Swelling in left arm; Pain in upper shoulder; Muscle pain over entire body; Strong fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm) and PERIPHERAL SWELLING (Swelling in left arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Aspirin), Drug allergy (Ibuprofen), Drug allergy (Hydrocloroquine), Drug allergy (Chloroquine) and Drug allergy (Hydroxychloroquine). Concomitant products included VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body), FATIGUE (Strong fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 30-May-2021 for Adverse event, at a dose of 1 dosage form and MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency. On 13-Jun-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body) and FATIGUE (Strong fatigue) outcome was unknown. Treatment include : hot compresses, ice. In July, patient went to urgent care and then her primary care physician, who switched her low dose of ibuprofen. This case was linked to (Patient Link).

Other Meds: VITAMIN D [VITAMIN D NOS]; IRON

Current Illness: Drug allergy (Ibuprofen); Drug allergy (Hydroxychloroquine); Drug allergy (Hydrocloroquine); Drug allergy (Chloroquine); Drug allergy (Aspirin)

ID: 1707555
Sex: U
Age:
State:

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
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: arm is really sore; extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted) 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 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted). At the time of the report, PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted) had not resolved. no concomitant medications are provided. treatment to the events not reported.

Other Meds:

Current Illness:

ID: 1707556
Sex: F
Age: 40
State: GA

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
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: Left side of face swelled; Cough; Cold; Migraine; Chills; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating), COUGH (Cough), NASOPHARYNGITIS (Cold), CHILLS (Chills) and MIGRAINE (Migraine). On 03-Sep-2021, the patient experienced SWELLING FACE (Left side of face swelled). On 06-Sep-2021, MIGRAINE (Migraine) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter denied pregnancy No concomitant medications reported. No treatment information was reported by reporter.

Other Meds:

Current Illness:

ID: 1707557
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: became blind; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (became blind) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (became blind) (seriousness criterion medically significant). At the time of the report, BLINDNESS (became blind) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1707558
Sex: U
Age:
State: NY

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: Covid-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Received the Moderna vaccines who tested positive for covid; Got sick; 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 COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick). At the time of the report, COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am