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: 1681565
Sex: M
Age: 79
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: dizzy spells; stiffness in face; tightness in face; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face). At the time of the report, DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that patient does not use insulin for diabetes. He just does exercise and takes a blood thinner. Patient has tried to correct the events with exercise. No concomitant medications were reported.

Other Meds:

Current Illness: Diabetes

ID: 1681566
Sex: F
Age: 27
State: MI

Vax Date: 07/29/2021
Onset Date: 08/06/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210806; Test Name: body temperature; Result Unstructured Data: Increased

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood cholesterol abnormal.Concomitant products included VITAMINS NOS for Vitamin supplementation, ATENOLOL for an unknown indication.On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) and BODY TEMPERATURE INCREASED (I had temperature for one night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for Pain in arm and Redness, at an unspecified dose and frequency. On 07-Aug-2021, BODY TEMPERATURE INCREASED (I had temperature for one night) had resolved. At the time of the report, VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) outcome was unknown and VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 06-Aug-2021, Body temperature: high (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Concomitant products also includes Cholesterol medication. Patient says she also used pain release cream for treatmeant

Other Meds: VITAMINS NOS; ATENOLOL

Current Illness: Blood cholesterol abnormal

ID: 1681567
Sex: F
Age: 58
State: PA

Vax Date: 02/03/2021
Onset Date: 02/05/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: D Dimer; Test Name: CBC; Result Unstructured Data: All fine except WBC; Test Name: Platelets

Allergies:

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

Symptoms: lip swelling; tongue swelling; Tingling lips/tingling tongue; pain whle lifting; lymph nodes swelling; ankle swelling; Shoulder pain; severe right arm Pain/severe pain while lifting; Weakness; hamstrings muscles atrophied; right upper thigh up to the buttocks pain and weakness; She could not climb up the stairs; shortness of breath; shooting jaw pain on the right side; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (severe right arm Pain/severe pain while lifting), ASTHENIA (Weakness), MUSCLE ATROPHY (hamstrings muscles atrophied), PAIN IN EXTREMITY (right upper thigh up to the buttocks pain and weakness) and MOBILITY DECREASED (She could not climb up the stairs) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Migraine on 01-Jan-2005 and Osteoporosis on 01-Jan-2000. Concurrent medical conditions included Anaphylaxis, Hypersensitivity NOS and Hives (Cause of this allergic reaction was NSAIDs.) since 12-Jan-2012. Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe right arm Pain/severe pain while lifting), ASTHENIA (Weakness), MUSCLE ATROPHY (hamstrings muscles atrophied), PAIN IN EXTREMITY (right upper thigh up to the buttocks pain and weakness), MOBILITY DECREASED (She could not climb up the stairs), DYSPNOEA (shortness of breath), PAIN IN JAW (shooting jaw pain on the right side), JOINT SWELLING (ankle swelling) and ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced LIP SWELLING (lip swelling), SWOLLEN TONGUE (tongue swelling), PARAESTHESIA ORAL (Tingling lips/tingling tongue), PAIN (pain whle lifting) and LYMPHADENOPATHY (lymph nodes swelling). The patient was treated with PREDNISONE at a dose of 8 days on a tapering dose.; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) (oral) on 02-Mar-2021 at a dose of 1 dosage form and RANITIDINE HYDROCHLORIDE (ZANTAC) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (severe right arm Pain/severe pain while lifting), ASTHENIA (Weakness), MUSCLE ATROPHY (hamstrings muscles atrophied), PAIN IN EXTREMITY (right upper thigh up to the buttocks pain and weakness), MOBILITY DECREASED (She could not climb up the stairs), DYSPNOEA (shortness of breath), PAIN IN JAW (shooting jaw pain on the right side), PAIN (pain whle lifting), JOINT SWELLING (ankle swelling), ARTHRALGIA (Shoulder pain) and LYMPHADENOPATHY (lymph nodes swelling) outcome was unknown and LIP SWELLING (lip swelling), SWOLLEN TONGUE (tongue swelling) and PARAESTHESIA ORAL (Tingling lips/tingling tongue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Fibrin D dimer: 299 High. On an unknown date, Full blood count: normal (normal) All fine except WBC. On an unknown date, Platelet count: 450 High. 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. The patient stated that her physician prescribed Prednisone for 8 days on a tapering dose, she also stated that They could not tell whether this was muscle/nerve damage or drug toxicity. She stated that she took anti allergy medication for lip swelling, Tongue tingling. This case was linked to MOD-2021-300796 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow-up received on 29-AUG-2021 contains significant information-History added, lab data added

Other Meds: MULTIVITAMIN & MINERAL

Current Illness: Anaphylaxis; Hives (Cause of this allergic reaction was NSAIDs.); Hypersensitivity NOS

ID: 1681568
Sex: M
Age: 12
State: FL

Vax Date: 08/23/2021
Onset Date:
Rec V Date: 09/08/2021
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: Patinent less than 12 years of age received the moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported.

Other Meds:

Current Illness:

ID: 1681569
Sex: M
Age: 83
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) 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 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown. Concomitant medication were not reported. Treatment medication were not reported. This case was linked to MOD-2021-294383, MOD-2021-294516 (Patient Link).

Other Meds:

Current Illness:

ID: 1681570
Sex: F
Age: 45
State: NY

Vax Date: 01/16/2021
Onset Date: 08/21/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bicep is swollen; Definitely a bad reaction; Lymph node of neck (left side) is swollen; Lymph node of injection arm is swollen; Injection site is red; Injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen). On an unknown date, the patient experienced PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph node of injection arm is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of unknown; PARACETAMOL (TYLENOL) at a dose of unknown; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of Unknown; CORTISONE ACETATE at a dose of Unknown; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of Unknown and NAPROXEN SODIUM (ALEVE) at a dose of unknown. At the time of the report, PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph node of injection arm is swollen) outcome was unknown. Patient thought to be used arthritis cream as treatment medication. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1681571
Sex: F
Age: 39
State: CA

Vax Date: 06/25/2021
Onset Date:
Rec V Date: 09/08/2021
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: After the 1st dose, she noticed a spike, like manifest, of her condition (OCD); After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Aug-2021 and was forwarded to Moderna on 23-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (After the 1st dose, she noticed a spike, like manifest, of her condition (OCD)) and FEELING ABNORMAL (After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The patient's past medical history included Brain injury. Concurrent medical conditions included Obsessive-compulsive disorder (Patient had OCD like germaphobia for the past 30+ years and it was manageable and under control). On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (After the 1st dose, she noticed a spike, like manifest, of her condition (OCD)) and FEELING ABNORMAL (After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.). At the time of the report, CONDITION AGGRAVATED (After the 1st dose, she noticed a spike, like manifest, of her condition (OCD)) and FEELING ABNORMAL (After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was taking a lot of medication but declined providing the medication list. Treatment information was not provided. This case was linked to MOD-2021-294492 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-Sep-2021 and contains non-significant information.

Other Meds:

Current Illness: Obsessive-compulsive disorder (Patient had OCD like germaphobia for the past 30+ years and it was manageable and under control).

ID: 1681572
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Dizziness; Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness). At the time of the report, SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment medication was reported by patient. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1681573
Sex: F
Age:
State: WI

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 09/08/2021
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: More than 6 months away from first shot and had not received the second shot; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID Arm) and PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot) 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. In January 2021, the patient experienced VACCINATION COMPLICATION (COVID Arm). On 23-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot). In January 2021, VACCINATION COMPLICATION (COVID Arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided Treatment information was not reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1681574
Sex: M
Age: 51
State: MI

Vax Date: 02/10/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included Cough (believes they had COVID-19 because they suffered having a bad cough back in 24Jan2020 through 15Feb2020) from 24-Jan-2020 to 15-Feb-2020. Concurrent medical conditions included Migraine. Concomitant products included FENTANYL, MORPHINE and TOPIRAMATE (TOPAMAX) for an unknown indication.On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia). In March 2021, PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia) had resolved. Treatment information was not provided. The patient explained these symptoms lasted through the first night, was gone the next day, then the pain came back the following day, and finally the next day it all went away.This case was linked to MOD-2021-294577, MOD-2021-294571 (Patient Link).

Other Meds: FENTANYL; MORPHINE; TOPAMAX

Current Illness: Migraine

ID: 1681575
Sex: F
Age: 55
State: NJ

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
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: Little sore arm; Little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little sore arm) and HEADACHE (Little headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy and MS. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MYALGIA (Little sore arm) and HEADACHE (Little headache). At the time of the report, MYALGIA (Little sore arm) and HEADACHE (Little headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use included infusions for MS. Treatment information was not provided. This case was linked to MOD-2021-294520 (Patient Link).

Other Meds:

Current Illness: MS; Sulfonamide allergy

ID: 1681576
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Hair falling out after both shots; 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 ALOPECIA (Hair falling out after both shots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. 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 ALOPECIA (Hair falling out after both shots). At the time of the report, ALOPECIA (Hair falling out after both shots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by reporter. No treatment details were provided by reporter. Abundance of red blood cells and abundance of red blood cells were reported as events.

Other Meds:

Current Illness:

ID: 1681577
Sex: U
Age:
State: HI

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose) 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 PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment medication was not provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: contains non significant information: Reporter address updated.

Other Meds:

Current Illness:

ID: 1681578
Sex: F
Age:
State: WA

Vax Date: 06/22/2021
Onset Date: 06/27/2021
Rec V Date: 09/08/2021
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: Her menstrual period is inconsistent, her menstrual period is on and off; she has it once every other week; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week). At the time of the report, MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1681579
Sex: M
Age: 63
State: FL

Vax Date: 02/16/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: COVID-19 antibodies test; Result Unstructured Data: produced 0 antibodies after 5 months.

Allergies:

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

Symptoms: My arm hurt a little bit for an hour; it hurt where the needle was after the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.). In March 2021, PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: 0 antibodies after 5 months (abnormal) produced 0 antibodies after 5 months.. No concomitant medications are provided. Patient Regular med: Diabetes medication. Patient doctor recommended him to get an antibody test and it returned with 0 antibodies. Patient would like to know why he has produced 0 antibodies after 5 months. This case was linked to MOD-2021-294841 (Patient Link).

Other Meds:

Current Illness:

ID: 1681580
Sex: F
Age: 73
State: IA

Vax Date: 03/18/2021
Onset Date: 06/18/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data: Test Date: 20210709; Test Name: blood pressure of 60/something; Result Unstructured Data: Low; Test Name: hear rate in the 30's; Result Unstructured Data: Low

Allergies:

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

Symptoms: tingling on left side of face/mouth; memory issues; weak; shaky; can't stay awake; speech slow and slurry; speech slow and slurry; knees gave out; loss control of bladder /incontinence; sounded intoxicated; TINGLING ON LEFT SIDE OF FACE; cannot drive with no warning; advised her to not take the second shot; MISSED DOSE; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (can't stay awake), DYSARTHRIA (speech slow and slurry), SLOW SPEECH (speech slow and slurry), INCONTINENCE (loss control of bladder /incontinence), PARAESTHESIA ORAL (tingling on left side of face/mouth), MEMORY IMPAIRMENT (memory issues), ASTHENIA (weak), NERVOUSNESS (shaky), MUSCULOSKELETAL DISCOMFORT (knees gave out), FEELING ABNORMAL (sounded intoxicated) and PARAESTHESIA (TINGLING ON LEFT SIDE OF FACE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced INCONTINENCE (loss control of bladder /incontinence) (seriousness criterion hospitalization). On 09-Jul-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (knees gave out) (seriousness criterion hospitalization). On an unknown date, the patient experienced SOMNOLENCE (can't stay awake) (seriousness criterion hospitalization), DYSARTHRIA (speech slow and slurry) (seriousness criterion hospitalization), SLOW SPEECH (speech slow and slurry) (seriousness criterion hospitalization), PARAESTHESIA ORAL (tingling on left side of face/mouth) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (memory issues) (seriousness criterion hospitalization), ASTHENIA (weak) (seriousness criterion hospitalization), NERVOUSNESS (shaky) (seriousness criterion hospitalization), FEELING ABNORMAL (sounded intoxicated) (seriousness criterion hospitalization), PARAESTHESIA (TINGLING ON LEFT SIDE OF FACE) (seriousness criterion hospitalization), IMPAIRED DRIVING ABILITY (cannot drive with no warning), PRODUCT DOSE OMISSION ISSUE (advised her to not take the second shot) and OFF LABEL USE (MISSED DOSE ). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to FEELING ABNORMAL and PARAESTHESIA. At the time of the report, SOMNOLENCE (can't stay awake), DYSARTHRIA (speech slow and slurry), SLOW SPEECH (speech slow and slurry), INCONTINENCE (loss control of bladder /incontinence), PARAESTHESIA ORAL (tingling on left side of face/mouth), MEMORY IMPAIRMENT (memory issues), ASTHENIA (weak), NERVOUSNESS (shaky), MUSCULOSKELETAL DISCOMFORT (knees gave out), FEELING ABNORMAL (sounded intoxicated), PARAESTHESIA (TINGLING ON LEFT SIDE OF FACE), IMPAIRED DRIVING ABILITY (cannot drive with no warning), PRODUCT DOSE OMISSION ISSUE (advised her to not take the second shot) and OFF LABEL USE (MISSED DOSE ) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, Blood pressure measurement: 60 (Low) Low. On an unknown date, Heart rate: 30 (Low) Low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. Patient received the first dose of the Moderna Vaccine (Lot #:045A21A) in her right arm on 18March2021. The patient reported she had a total of 9 episodes since 19March2021, the day after her first shot. Patient reported experiencing episodes where she cannot drive with no warning, can't stay awake, speech slow and slurry, sounded intoxicated, loss control of bladder and tingling on the left side of her face/mouth, memory issues, weak, shaky, heart rate in the 30's. Patient reported that her EKG test and blood work comes out normal. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1681581
Sex: M
Age: 63
State: FL

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

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

Lab Data: Test Date: 20210816; Test Name: Antibody test; Test Result: Negative ; Result Unstructured Data: 0 antibodies

Allergies:

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

Symptoms: Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059D21A, 001B21A and 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt). At the time of the report, PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Antibody test: 0 antibodies (Negative) 0 antibodies. No concomitant medications were provided. No treatment medications were reported. This case was linked to MOD-2021-294807 (Patient Link).

Other Meds:

Current Illness:

ID: 1681582
Sex: F
Age: 69
State: MA

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 09/08/2021
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: Her insomnia got worse after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Her insomnia got worse after 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Her insomnia got worse after 2nd dose). The patient was treated with TRAZODONE ongoing since an unknown date for Chronic insomnia, at a dose of 50 mg. At the time of the report, INSOMNIA (Her insomnia got worse after 2nd dose) outcome was unknown. This case was linked to MOD-2021-294902 (Patient Link).

Other Meds: SYNTHROID; ATORVASTATIN

Current Illness:

ID: 1681583
Sex: M
Age:
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 09/08/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen). At the time of the report, VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen) had not resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient takes other concomitant medicine but not specified Patient used oil for treating dried skin

Other Meds:

Current Illness:

ID: 1681584
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER) 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 (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER). At the time of the report, VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant and treatment drugs were not provided Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Followup Recived on 24-AUG-2021, dose no. of the suspect vaccine added.

Other Meds:

Current Illness:

ID: 1681585
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 (He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not reported. No treatment medications were not provided. Patient date of birth was deleted upon IRMS documentation crash. While month and day are lost, born in 1980.

Other Meds:

Current Illness:

ID: 1681586
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: entire body start burning after the injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (entire body start burning after the injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. 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 BURNING SENSATION (entire body start burning after the injection). At the time of the report, BURNING SENSATION (entire body start burning after the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681587
Sex: F
Age: 85
State: AL

Vax Date: 07/25/2021
Onset Date: 08/06/2021
Rec V Date: 09/08/2021
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: The caller states she is almost well except she does still have a little pain in her arm where she received the injection.; Hard (at injection site); Itchy (at injection site); Real, Real Red (at injection site); Hot (at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot (at injection site)), VACCINATION SITE PAIN (The caller states she is almost well except she does still have a little pain in her arm where she received the injection.), VACCINATION SITE INDURATION (Hard (at injection site)), VACCINATION SITE PRURITUS (Itchy (at injection site)) and VACCINATION SITE ERYTHEMA (Real, Real Red (at injection site)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included PROBIOTICS NOS for an unknown indication. On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot (at injection site)), VACCINATION SITE INDURATION (Hard (at injection site)), VACCINATION SITE PRURITUS (Itchy (at injection site)) and VACCINATION SITE ERYTHEMA (Real, Real Red (at injection site)). On an unknown date, the patient experienced VACCINATION SITE PAIN (The caller states she is almost well except she does still have a little pain in her arm where she received the injection.). The patient was treated with CALAMINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot (at injection site)), VACCINATION SITE INDURATION (Hard (at injection site)), VACCINATION SITE PRURITUS (Itchy (at injection site)) and VACCINATION SITE ERYTHEMA (Real, Real Red (at injection site)) was resolving and VACCINATION SITE PAIN (The caller states she is almost well except she does still have a little pain in her arm where she received the injection.) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included pills for blood pressure and cholesterol. Treatment also included ice bags which have helped to take away the redness and an ointment that isn't Benadryl, but similar. Patient is scheduled to receive the second dose on 28AUG2021. Patient went to the pharmacy and the pharmacist said she may have cellulitis. Then she went to the doctor and did not have cellulitis because she didn't have a fever. The caller's physician has told her not to receive the second dose.

Other Meds: PROBIOTICS NOS

Current Illness: Blood pressure; Cholesterol

ID: 1681588
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: 6 moths after 2 shot, skin is painful when exposed to bright sun; 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 PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun). At the time of the report, PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681589
Sex: F
Age: 65
State: SC

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 09/08/2021
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: This spontaneous case reported by a consumer, describes the occurrence of pain, aches and headache in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027A21A) for COVID-19 immunization. The patient's past medical history included splenectomy. Concurrent medical conditions included immunocompromised (she is immunocompromised since she had her spleen removed). Concomitant product: clonazepam taken half of a 2.5 mg at night for sleep problem. On Mar 10, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 10, 2021, patient experienced pain, aches and headache. Patient treated with Tylenol (paracetamol) for adverse event, at an unspecified dose and frequency. On Mar 12, 2021, pain, aches and headache resolved. The reporter did not provide any causality assessments or treatment information. This case linked to MOD-2021-295323 (patient link).

Other Meds: Clonazepam

Current Illness: Immunocompromised (she is immunocompromised since she had her spleen removed).

ID: 1681590
Sex: F
Age: 27
State: NC

Vax Date: 03/25/2021
Onset Date: 04/22/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210527; Test Name: MRI; Test Result: Inconclusive ; Result Unstructured Data: completely normal

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing), NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) and NERVE BLOCK (On 04Aug2021, she got another block) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache,never went away, nonstop,headaches haven't gone away). On 29-Apr-2021, the patient experienced EAR DISCOMFORT (pounding in my ear,feels like a pulsing). On 02-Jun-2021, the patient experienced NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.). On 04-Aug-2021, the patient experienced NERVE BLOCK (On 04Aug2021, she got another block). On an unknown date, the patient experienced OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out) and PAIN (pain ranges between 2-10). The patient was treated with DOXYCYCLINE from 22-Apr-2021 to 04-May-2021 at a dose of 40 milligram. At the time of the report, OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing) and NERVE BLOCK (On 04Aug2021, she got another block) outcome was unknown, NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) had resolved and HEADACHE (headache,never went away, nonstop,headaches haven't gone away) had not resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Magnetic resonance imaging: normal (Inconclusive) completely normal.Patient had close to 10 doctor visits between specialists and her primary care but they can't figure out what's wrong.Patient stopped taking it because her doctor told her it could cause headache. Patient stated that the pain ranges between 2-10 on any given day.This case was linked to MOD-2021-295321 (Patient Link).

Other Meds:

Current Illness:

ID: 1681591
Sex: M
Age: 59
State: TX

Vax Date: 04/30/2021
Onset Date:
Rec V Date: 09/08/2021
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: Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd) had resolved. Concomitant medications were not reported. Treatment medications were not reported.

Other Meds:

Current Illness:

ID: 1681592
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: only received the first dose,several months later are coming for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose) 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 PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1681593
Sex: F
Age: 60
State: CA

Vax Date: 08/05/2021
Onset Date: 08/19/2021
Rec V Date: 09/08/2021
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: I had a little bit of swelling in the site of injection; Fever; I cannot make any movements because my neck make sound; I feel like my neck is going to break; I started, when turning my head back, making sound, it sounds very ugly; It hurts in my neck, where the spine begins in the head; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I cannot make any movements because my neck make sound), MUSCULOSKELETAL DISCOMFORT (I feel like my neck is going to break), HEAD BANGING (I started, when turning my head back, making sound, it sounds very ugly), NECK PAIN (It hurts in my neck, where the spine begins in the head) and VACCINATION SITE SWELLING (I had a little bit of swelling in the site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history provided. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MOBILITY DECREASED (I cannot make any movements because my neck make sound), MUSCULOSKELETAL DISCOMFORT (I feel like my neck is going to break), HEAD BANGING (I started, when turning my head back, making sound, it sounds very ugly) and NECK PAIN (It hurts in my neck, where the spine begins in the head). On an unknown date, the patient experienced VACCINATION SITE SWELLING (I had a little bit of swelling in the site of injection) and PYREXIA (Fever). The patient was treated with IBUPROFEN ongoing since an unknown date for Product used for unknown indication, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (I cannot make any movements because my neck make sound), MUSCULOSKELETAL DISCOMFORT (I feel like my neck is going to break), HEAD BANGING (I started, when turning my head back, making sound, it sounds very ugly), NECK PAIN (It hurts in my neck, where the spine begins in the head), VACCINATION SITE SWELLING (I had a little bit of swelling in the site of injection) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1681594
Sex: M
Age: 67
State: MO

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

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

Lab Data: Test Date: 20210128; Test Name: Increased blood pressure; Result Unstructured Data: High

Allergies:

Symptom List: Nausea

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported by reporter. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Blood pressure increased: high (High) High.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Treatment information was not provided. This case was linked to MOD-2021-295405 (Patient Link).

Other Meds: BENADRYL 24 D

Current Illness:

ID: 1681595
Sex: F
Age:
State: MO

Vax Date: 08/24/2021
Onset Date: 08/23/2021
Rec V Date: 09/08/2021
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: Expired vaccine administered to patient; She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours). On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 24-Aug-2021, PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was administered dose using the expired punctured vial beyond 12 hours. No concomitant medications were mentioned. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1681596
Sex: M
Age: 79
State: TX

Vax Date: 02/09/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210818; Test Name: blood pressure; Result Unstructured Data: elevated

Allergies:

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

Symptoms: intense ringing in the ears; headache; 1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of TINNITUS (intense ringing in the ears), HEADACHE (headache) and INCORRECT DOSE ADMINISTERED (1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 032M20A and 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Lymphocytic colitis. Concomitant products included EZETIMIBE (ZETIA), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, GARLIC [ALLIUM SATIVUM], VITAMIN C [ASCORBIC ACID], MONASCUS PURPUREUS (RED YEAST RICE), SIMVASTATIN (ZOCOR), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ZONISAMIDE, MELOXICAM, FOLIC ACID, ASPIRIN [ACETYLSALICYLIC ACID], MELATONIN, PYRIDOXINE HYDROCHLORIDE (MELATONIN [MELATONIN;PYRIDOXINE HYDROCHLORIDE]), FISH OIL, UBIDECARENONE (COQ10 [UBIDECARENONE]), MAGNESIUM, BUDESONIDE, CUCURBITA PEPO OIL, SERENOA REPENS, ZINC GLUCONATE (SAW PALMETTO [CUCURBITA PEPO OIL;SERENOA REPENS;ZINC GLUCONATE]) and PROBIOTICS [UMBRELLA TERM] for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced TINNITUS (intense ringing in the ears), HEADACHE (headache) and INCORRECT DOSE ADMINISTERED (1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021). On 18-Aug-2021, INCORRECT DOSE ADMINISTERED (1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021) had resolved. At the time of the report, TINNITUS (intense ringing in the ears) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Blood pressure measurement: high mmHg (High) elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug details were reported. Patient did not experience any adverse events after 1st and 2nd dose. Patient experienced adverse events after 3rd dose, which was authorized by his HCP due to his conditions/medications. Patient has a condition called lymphatic colitis, and the medication for it makes him immunocompromised.

Other Meds: ZETIA; CRESTOR; OMEPRAZOLE; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;; GARLIC [ALLIUM SATIVUM]; VITAMIN C [ASCORBIC ACID]; RED YEAST RICE; ZOCOR; BYSTOLIC; ZONISAMIDE; MELOXICAM; FO

Current Illness: Lymphocytic colitis

ID: 1681597
Sex: F
Age: 76
State: CO

Vax Date: 01/05/2021
Onset Date: 08/14/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: Body temperature; Result Unstructured Data: Fever

Allergies:

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

Symptoms: a very bad reaction; was very very sick; bedridden for at least 3 days; coughing; sore throat; running nose; was deathly ill/She thought she was dying; arm became incredibly swollen, very swollen; arm became hot, very hot; very weak; lots of muscle ache/arm became sore; very tired; a mild headache; temperature got up to 101.7 or higher/very high temperature; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very bad reaction), ILLNESS (was very very sick), BEDRIDDEN (bedridden for at least 3 days), COUGH (coughing) and OROPHARYNGEAL PAIN (sore throat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 025120-2A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blind, Immunocompromised and Drug allergy (allergic to most medications.). Concomitant products included INSULIN, CLOPIDOGREL BISULFATE (PLAVIX), EZETIMIBE (ZETIA) and ATORVASTATIN for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced PYREXIA (temperature got up to 101.7 or higher/very high temperature). On an unknown date, the patient experienced VACCINATION COMPLICATION (a very bad reaction), ILLNESS (was very very sick), BEDRIDDEN (bedridden for at least 3 days), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), FEELING ABNORMAL (was deathly ill/She thought she was dying), PERIPHERAL SWELLING (arm became incredibly swollen, very swollen), FEELING HOT (arm became hot, very hot), ASTHENIA (very weak), MYALGIA (lots of muscle ache/arm became sore), FATIGUE (very tired) and HEADACHE (a mild headache). At the time of the report, VACCINATION COMPLICATION (a very bad reaction), ILLNESS (was very very sick), BEDRIDDEN (bedridden for at least 3 days), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), FEELING ABNORMAL (was deathly ill/She thought she was dying), PERIPHERAL SWELLING (arm became incredibly swollen, very swollen), FEELING HOT (arm became hot, very hot), ASTHENIA (very weak), MYALGIA (lots of muscle ache/arm became sore), FATIGUE (very tired), PYREXIA (temperature got up to 101.7 or higher/very high temperature) and HEADACHE (a mild headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Body temperature: 101.7 (High) Fever. She said she had a very bad reaction to the booster shot. She said she's immunocompromised and allergic to most medications. Patient was put on antibiotic for possible infection, although the follow up doctor didn't think she had an infection. Patient used cold pack on the arm. Patient went to the urgent health and didn't go to her primary care. She went to a skin doctor to look at her arm. This case was linked to MOD-2021-295425 (Patient Link).

Other Meds: INSULIN; PLAVIX; ZETIA; ATORVASTATIN

Current Illness: Blind; Drug allergy (allergic to most medications.); Immunocompromised

ID: 1681598
Sex: U
Age:
State: MA

Vax Date: 08/24/2021
Onset Date:
Rec V Date: 09/08/2021
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: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, 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 (Received dose from a vial that was punctured for more than 12hs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported. Nurse had an event in the facility where they work that was opened 9 am 23Aug2021. After that it was stored refrigerated between 2-8?C and today 24Aug2021 doses from that vial were administered to 4 patients. Nurse understands the vial expired by 9 pm 23Aug2021 although it was stored refrigerated.

Other Meds:

Current Illness:

ID: 1681599
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Very weak and long lasting headache; Every muscle in my body ached; Very weak and long lasting 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 ASTHENIA (Very weak and long lasting headache), MYALGIA (Every muscle in my body ached) and HEADACHE (Very weak and long lasting 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 ASTHENIA (Very weak and long lasting headache), MYALGIA (Every muscle in my body ached) and HEADACHE (Very weak and long lasting headache). At the time of the report, ASTHENIA (Very weak and long lasting headache), MYALGIA (Every muscle in my body ached) and HEADACHE (Very weak and long lasting headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. The patient had these symptoms started approximately 10 hours after the shot. All night and all day today. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1681600
Sex: U
Age:
State:

Vax Date: 08/23/2021
Onset Date:
Rec V Date: 09/08/2021
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: A lot of pain in the arm; Could not sleep; Woke up with bone pain; Woke up with shivers; Going to stand and gets tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A lot of pain in the arm), INSOMNIA (Could not sleep), BONE PAIN (Woke up with bone pain), CHILLS (Woke up with shivers) and FATIGUE (Going to stand and gets tired) 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 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A lot of pain in the arm), INSOMNIA (Could not sleep), BONE PAIN (Woke up with bone pain), CHILLS (Woke up with shivers) and FATIGUE (Going to stand and gets tired). At the time of the report, PAIN IN EXTREMITY (A lot of pain in the arm), INSOMNIA (Could not sleep), BONE PAIN (Woke up with bone pain), CHILLS (Woke up with shivers) and FATIGUE (Going to stand and gets tired) 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 medication was provided.

Other Meds:

Current Illness:

ID: 1681601
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Missed 2nd dose/it has been 15 weeks since the first one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/it has been 15 weeks since the first one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. 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 PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/it has been 15 weeks since the first one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/it has been 15 weeks since the first one) had resolved. No Concomitant and Treatment medication were not reported.

Other Meds:

Current Illness:

ID: 1681602
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain at left arm) 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 MYALGIA (muscle pain at left arm). At the time of the report, MYALGIA (muscle pain at left arm) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Relevant concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681603
Sex: U
Age:
State: GA

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients; Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients). In August 2021, EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. The Moderna vaccine vial what was punctured at 9:07am on 17-Aug-2021. This vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients for their 3rd dose. Some patients received it on 19-Aug-2021 between 01 pm and 09 pm. Some patients received it on 20-Aug-2021 between 02pm-07pm and two patients received it on 23-Aug-2021, which was 6 days after the vial was punctured. Pharmacist provided BTIN number: 00380777273983. Pharmacist asked what they should do. Agent forgot to obtain safety follow up consent, but pharmacist consented to follow up from Medical Affairs. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681604
Sex: M
Age:
State: OH

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

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

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

Allergies:

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

Symptoms: COVID-19; High temperature; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PYREXIA (High temperature) and FATIGUE (Tired) 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. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 COVID-19 (COVID-19) (seriousness criterion hospitalization prolonged), PYREXIA (High temperature) (seriousness criterion hospitalization prolonged) and FATIGUE (Tired) (seriousness criterion hospitalization prolonged). The patient was hospitalized for 5 days due to COVID-19, FATIGUE and PYREXIA. At the time of the report, COVID-19 (COVID-19), PYREXIA (High temperature) and FATIGUE (Tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. Patient was given antibiotics to treat symptoms.No concomitant medications were provided. It was reported that patient was hospitalized for 5 days but the disease lasted 3-4 weeks Company comment: For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available very limited information and temporal association between the use of the product and the start date of the events of fatigue and pyrexia, a causal relationship cannot be excluded. However, very limited information regarding vaccination and event dates is provided. Further information has been requested.; Sender's Comments: For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available very limited information and temporal association between the use of the product and the start date of the events of fatigue and pyrexia, a causal relationship cannot be excluded. However, very limited information regarding vaccination and event dates is provided. Further information has been requested

Other Meds:

Current Illness:

ID: 1681605
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Does the vaccine have deadly side effects for people with heart diease; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Does the vaccine have deadly side effects for people with heart diease) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Does the vaccine have deadly side effects for people with heart diease). At the time of the report, VACCINATION COMPLICATION (Does the vaccine have deadly side effects for people with heart diease) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1681606
Sex: F
Age: 39
State: MO

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/08/2021
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: chest pain; chest pressure; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHEST DISCOMFORT (chest pressure) and PAIN IN EXTREMITY (very sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 13-Aug-2021, the patient experienced CHEST PAIN (chest pain), CHEST DISCOMFORT (chest pressure) and PAIN IN EXTREMITY (very sore arm). On 15-Aug-2021, CHEST PAIN (chest pain), CHEST DISCOMFORT (chest pressure) and PAIN IN EXTREMITY (very sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient experienced sore arm, chest pain, and chest pressure four hours after the first dose, chest pain and pressure never lasted more than a minute and continued to happen off and on that weekend. The symptoms resolved after Sunday,15-Aug-2021. She did not take any treatment to help with the symptoms.

Other Meds:

Current Illness:

ID: 1681607
Sex: F
Age: 72
State:

Vax Date: 01/22/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: flu like symptoms; severe headache; terrible body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache) and MYALGIA (terrible body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 024M20A and 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised, Heart disorder and Lung disease. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache) and MYALGIA (terrible body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache) and MYALGIA (terrible body aches) outcome was unknown. Treatment medication was not reported. This case was linked to MOD-2021-295648 (Patient Link).

Other Meds: TYLENOL

Current Illness: Heart disorder; Immunocompromised; Lung disease

ID: 1681608
Sex: M
Age: 59
State: AZ

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/08/2021
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: bone pain; swelling in the injection site; soreness in his arm; tiredness/ Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), VACCINATION SITE SWELLING (swelling in the injection site), MYALGIA (soreness in his arm), FATIGUE (tiredness/ Fatigue) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062e21a) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced BONE PAIN (bone pain), VACCINATION SITE SWELLING (swelling in the injection site), MYALGIA (soreness in his arm), FATIGUE (tiredness/ Fatigue) and CHILLS (chills). At the time of the report, BONE PAIN (bone pain), VACCINATION SITE SWELLING (swelling in the injection site), MYALGIA (soreness in his arm), FATIGUE (tiredness/ Fatigue) and CHILLS (chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1681609
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: very late getting second shot; 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 PRODUCT DOSE OMISSION ISSUE (very late getting second shot) 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 PRODUCT DOSE OMISSION ISSUE (very late getting second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (very late getting second shot) had resolved. No Concomitant drugs were reported. No Treatment information were reported. This case was linked to MOD-2021-295739 (Patient Link).

Other Meds:

Current Illness:

ID: 1681610
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681611
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Mild Reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild Reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild Reaction). At the time of the report, VACCINATION COMPLICATION (Mild Reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drug details were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1681612
Sex: F
Age:
State: FL

Vax Date: 07/24/2021
Onset Date: 07/24/2021
Rec V Date: 09/08/2021
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: They were supposed to get their 2nd vaccine this past Saturday; 17 year old patient received 1st dose/17 year old daughter accidentally given the 1st dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1st dose/17 year old daughter accidentally given the 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (They were supposed to get their 2nd vaccine this past Saturday) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1st dose/17 year old daughter accidentally given the 1st dose of the Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (They were supposed to get their 2nd vaccine this past Saturday). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1st dose/17 year old daughter accidentally given the 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (They were supposed to get their 2nd vaccine this past Saturday) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported. Reporter stated that her daughter was supposed to get their 2nd vaccine this past Saturday but the pediatrician was refusing to give the second one to them. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up received was non- significant.

Other Meds:

Current Illness:

ID: 1681613
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Blood Pressure; Result Unstructured Data: elevated

Allergies:

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

Symptoms: Is it normal for my blood pressure to be elevated the day after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Is it normal for my blood pressure to be elevated the day after the 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 BLOOD PRESSURE INCREASED (Is it normal for my blood pressure to be elevated the day after the vaccine). At the time of the report, BLOOD PRESSURE INCREASED (Is it normal for my blood pressure to be elevated the day after the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1681614
Sex: F
Age:
State:

Vax Date: 05/01/2021
Onset Date: 08/23/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: She has been fully vaccinated for 3 months, yet she tested positive for COVID on 8/23/21.; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (She has been fully vaccinated for 3 months, yet she tested positive for COVID on 8/23/21.) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (She has been fully vaccinated for 3 months, yet she tested positive for COVID on 8/23/21.). At the time of the report, SARS-COV-2 TEST POSITIVE (She has been fully vaccinated for 3 months, yet she tested positive for COVID on 8/23/21.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. No Concomitant medication information was reported. No Treatment medications were provided.; Sender's Comments: This case concerns a 19 years all female, who tested positive SARS-CoV-2 after 3 month of complete vaccination. Therefore, causality for this event is assessed as not applicable.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am