VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1644193
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Reaction to vaccine/many problems; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to vaccine/many problems) 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 (Reaction to vaccine/many problems). At the time of the report, VACCINATION COMPLICATION (Reaction to vaccine/many problems) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. There was no concomitant medication reported. There was no treatment medication reported. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received contains significant information, updated verbatim term to Reaction to vaccination/many problems.

Other Meds:

Current Illness:

ID: 1644194
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: same big red rash to injection site arm with the second vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine). At the time of the report, RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine) had resolved. Concomitant medications included unspecified blood pressure medications. The red rash resolved after 3-4 days. She did not take any treatment medications for the adverse events. This case was linked to MOD-2021-067353, MOD-2021-106494 (Patient Link).

Other Meds:

Current Illness: Hypertension

ID: 1644195
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Outbreak of Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Outbreak of Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Outbreak of Shingles). At the time of the report, HERPES ZOSTER (Outbreak of Shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1644196
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Shingles; 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 HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. No concomitant medication reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The SD attached is unable to be read.

Other Meds:

Current Illness:

ID: 1644197
Sex: U
Age:
State: OH

Vax Date: 06/30/2021
Onset Date: 06/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine; Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine; 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 OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer 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 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine). At the time of the report, OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) outcome was unknown. 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 relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1644198
Sex: M
Age:
State: AL

Vax Date: 04/20/2021
Onset Date: 05/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: dose given 20hrs after vial expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002c21 and 002c21) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN for Cholesterol, INSULIN GLARGINE (TOUJEO) and GLIPIZIDE for Diabetes. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. This case was linked to MOD-2021-162276 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional information received on 30-06-2021 contain patient demographic

Other Meds: TOUJEO; GLIPIZIDE; ATORVASTATIN; LISINOPRIL

Current Illness: Type 2 diabetes mellitus

ID: 1644199
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Skin breakout (Patient had a very bad reaction). Concurrent medical conditions included Iodine allergy (Patient was recently been released from the hospital after taking a test in which they injected Iodine into patient for a procedure). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. No concomitant medication was reported. No treatment medication reported. This case was linked to MOD-2021-098289 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: significant follow-up. event sore arm after the shot updated.

Other Meds:

Current Illness: Iodine allergy (Patient was recently been released from the hospital after taking a test in which they injected Iodine into patient for a procedure)

ID: 1644200
Sex: M
Age:
State: MD

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

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

Lab Data: Test Date: 2021; Test Name: Troponin; Result Unstructured Data: elevated.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the US military. International peer review. 2021 No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain. Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Author comment clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-245527, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644201
Sex: F
Age:
State: NY

Vax Date: 04/02/2021
Onset Date: 04/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Swollen gums/Blisters; Jaw pain, poping, locking, chewing, opening mouth and yawning problem; Fatigue; Fever; Chills; Headache; Swollen glands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (Swollen gums/Blisters), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands). 30-Apr-2021, the patient experienced TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem). The patient was treated with Manual therapy (got mouthguard) for Temporomandibular joint syndrome. On 07-May-2021, BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands) had resolved. At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem) had not resolved. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Jaw pain started after two days of vaccination. Patient's primary doctor and dentist told her that might be TMJ. This case was linked to MOD-2021-068490 (Patient Link).

Other Meds:

Current Illness:

ID: 1644202
Sex: M
Age:
State: NY

Vax Date: 04/02/2021
Onset Date: 04/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Blisters; Swollen gums; Dizziness; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). On 07-May-2021, BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. No concomitant medication was reported No treatment medication were provided. This case was linked to MOD-2021-068600 (Patient Link).

Other Meds:

Current Illness:

ID: 1644203
Sex: F
Age: 55
State: TX

Vax Date: 02/10/2021
Onset Date: 05/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210629; Test Name: Biopsy; Result Unstructured Data: positive biopsy in the uterus; Test Date: 20210510; Test Name: PET scan; Result Unstructured Data: saw an enlarged lymph node on the left side of the neck.

Allergies:

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

Symptoms: enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031A21A) for COVID-19 vaccination. The patient's past medical history included Hysterectomy on 28-May-2021. Concurrent medical conditions included Pre-diabetes since 01-Jan-2012 and Hypothyroidism since 01-Jan-2011. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY). On 03-Jul-2021, LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Positron emission tomogram: abnormal (abnormal) saw an enlarged lymph node on the left side of the neck.. On 29-Jun-2021, Biopsy: abnormal (abnormal) positive biopsy in the uterus. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. It was reported that, in April/May patient was given a PET scan where they found enlarged lymph node in neck (left side), same side as the shots were given. In Jun, then the patient had to under go a needle biopsy in order to rule out cancer. The biopsy came back negative. The patient's oncologist agreed that this was caused by the Covid shot. No treatment medication reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant FU. medical history added.Event information updated. outcome of event recovered/resolved added.

Other Meds:

Current Illness: Hypothyroidism; Pre-diabetes

ID: 1644204
Sex: F
Age: 49
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: COVID-19 Virus Test; Test Result: Negative ; Result Unstructured Data: Virus not detected

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Debilitating tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Debilitating tinnitus) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination. No Medical History was provided. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Debilitating tinnitus). At the time of the report, TINNITUS (Debilitating tinnitus) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Virus not detected. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow-up received and contains no new information.

Other Meds:

Current Illness:

ID: 1644205
Sex: F
Age: 57
State: AZ

Vax Date: 03/26/2021
Onset Date: 04/23/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Pain sometimes in back; Could not mover her body / not able to climb into her bed or her car sometimes; Pain is sometimes in shoulder; Damage in left eye; Had a lot of pain; excruciating muscle cramp in the leg that moved around the body / Cramps and pain all over body; arm hurt; body pain that lasted three days / pain all over body / Pain sometimes on both sides of her body; I had fever; I felt dizzy; I had dry mouth; swollen; redness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain is sometimes in shoulder), EYE INJURY (Damage in left eye), BACK PAIN (Pain sometimes in back), MOBILITY DECREASED (Could not mover her body / not able to climb into her bed or her car sometimes) and PAIN (Had a lot of pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 02A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced DIZZINESS (I felt dizzy), DRY MOUTH (I had dry mouth), PERIPHERAL SWELLING (swollen), ERYTHEMA (redness), PAIN IN EXTREMITY (arm hurt), MYALGIA (body pain that lasted three days / pain all over body / Pain sometimes on both sides of her body) and PYREXIA (I had fever). On 04-Jun-2021, the patient experienced EYE INJURY (Damage in left eye) (seriousness criterion hospitalization) and PAIN (Had a lot of pain) (seriousness criterion hospitalization). 04-Jun-2021, the patient experienced MUSCLE SPASMS (excruciating muscle cramp in the leg that moved around the body / Cramps and pain all over body). On an unknown date, the patient experienced ARTHRALGIA (Pain is sometimes in shoulder) (seriousness criterion hospitalization), BACK PAIN (Pain sometimes in back) (seriousness criterion hospitalization) and MOBILITY DECREASED (Could not mover her body / not able to climb into her bed or her car sometimes) (seriousness criterion hospitalization). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Pain is sometimes in shoulder), EYE INJURY (Damage in left eye), BACK PAIN (Pain sometimes in back), MOBILITY DECREASED (Could not mover her body / not able to climb into her bed or her car sometimes), PAIN (Had a lot of pain), DIZZINESS (I felt dizzy), DRY MOUTH (I had dry mouth), PERIPHERAL SWELLING (swollen), ERYTHEMA (redness), MUSCLE SPASMS (excruciating muscle cramp in the leg that moved around the body / Cramps and pain all over body), PAIN IN EXTREMITY (arm hurt), MYALGIA (body pain that lasted three days / pain all over body / Pain sometimes on both sides of her body) and PYREXIA (I had fever) outcome was unknown. No concomitant medication was provided. This case concerns a 58-year-old female with serious unexpected events of eye injury, back pain, arthralgia, mobility decreased, pain, and non-serious dizziness, dry mouth, peripheral swelling, erythema, muscle spasms, pain in extremity, myalgia, and pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-245665 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains additional events of shoulder pain, eye damage, back pain, mobility decreased and pain with seriousness criteria of hospitalization. Updated second dose start date from 24-Apr-2021 to 26-Apr-2021. Corrected first dose start date from Mar-2021 to 26-Mar-2021. Updated batch/lot number of first dose.; Sender's Comments: This case concerns a 58-year-old female with serious unexpected events of eye injury, back pain, arthralgia, mobility decreased, pain, and non-serious dizziness, dry mouth, peripheral swelling, erythema, muscle spasms, pain in extremity, myalgia, and pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644206
Sex: F
Age:
State: CA

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

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

Lab Data: Test Date: 20210617; Test Name: Biopsy; Test Result: Inconclusive ; Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: 160/94; Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: 97.7; Test Date: 20210127; Test Name: Heart rate; Result Unstructured Data: 91; Test Date: 20210127; Test Name: Respiratory rate; Result Unstructured Data: 98

Allergies:

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

Symptoms: Atopic dermatitis; itching on skin face and neck; Erythema; Urticaria; Heart rate increased; Itching and redness in eyes; Feeling Hot; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria) and HEART RATE INCREASED (Heart rate increased) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic interstitial cystitis, Irritable bowel syndrome, Sleep apnea, Prediabetes and Rhinitis. Concomitant products included BACLOFEN, CITALOPRAM HYDROBROMIDE (CITALOPRAM [CITALOPRAM HYDROBROMIDE]), METFORMIN and PENTOSAN POLYSULFATE SODIUM (ELMIRON) for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of 2- 3 tabs a day; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 4 shots and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at an unspecified dose and frequency. At the time of the report, DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 160/94 mmHg (High) 160/94. On 27-Jan-2021, Body temperature: 97.7 (normal) 97.7. On 27-Jan-2021, Heart rate: 91 (normal) 91. On 27-Jan-2021, Respiratory rate: 98 (abnormal) 98. On 17-Jun-2021, Biopsy: Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-133981.

Other Meds: BACLOFEN; CITALOPRAM [CITALOPRAM HYDROBROMIDE]; METFORMIN; ELMIRON

Current Illness: Chronic interstitial cystitis; Irritable bowel syndrome; Prediabetes; Rhinitis; Sleep apnea

ID: 1644207
Sex: F
Age: 67
State:

Vax Date: 01/30/2021
Onset Date: 06/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: nodule; This spontaneous case was reported by an other health care professional and describes the occurrence of NODULE (nodule) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Dental cleaning (Patient had dental cleaning within the last 6-12 months.). Previously administered products included for an unreported indication: INFLUENZA VACCINE (She had the flu shot in the fall of 2020.) in 2020. Concurrent medical conditions included Notalgia paresthetica. Concomitant products included TRAZODONE for Insomnia, GABAPENTIN for Notalgia paresthetica, POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) from 07-Jun-2021 to an unknown date, HYALURONIC ACID (JUVEDERM), BOTULINUM TOXIN TYPE A (BOTOX), HYALURONIC ACID (RESTYLANE), HYALURONIC ACID, LIDOCAINE (RESTYLANE L) and BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX (DYSPORT) for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced NODULE (nodule). At the time of the report, NODULE (nodule) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The HCP said to massage nodule 2x a day for 2 minutes for 2 weeks but the patient had been told by previous providers to do it 5 minutes a day 5 x for 5 weeks. Her husband who is a retired physician thinks it's about a 2-3 mm nodule. Patient has had Voluma, Vollure, in past. Treatment information was not provided.

Other Meds: GABAPENTIN; TRAZODONE; SCULPTRA AESTHETIC; JUVEDERM; BOTOX; RESTYLANE; RESTYLANE L; DYSPORT

Current Illness: Notalgia paresthetica

ID: 1644208
Sex: F
Age: 54
State: NY

Vax Date: 02/27/2021
Onset Date: 03/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: brain issue; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and CEREBRAL DISORDER (brain issue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 001A21A) for COVID-19 vaccination. The patient's past medical history included Barrett's esophagus on 15-Apr-2021. Concurrent medical conditions included Hypothyroidism since 01-Mar-2009 and Hypertension since 01-Mar-2006. Concomitant products included OMEPRAZOLE from 2012 to an unknown date for Gastroesophageal reflux, LISINOPRIL from 2006 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 2009 to an unknown date for Hypothyroidism. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced CEREBRAL DISORDER (brain issue). At the time of the report, TINNITUS (Tinnitus) and CEREBRAL DISORDER (brain issue) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant follow up appended: Reporter address was added. The patient demography updated. Medical History included Hypothyroidism, Hypertension and Barrett's Esophagus were added. Suspected 2nd dose updated. Concomitant medications LEVOTHYROXIN, LISINOPRIL, OMEPRAZOLE were added. Event Tinnitis start date and outcome was updated and additional event brain issue was added.

Other Meds: LEVOTHYROXIN; LISINOPRIL; OMEPRAZOLE

Current Illness: Hypertension; Hypothyroidism

ID: 1644209
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: "My 15yr old daughter had her covid vaccine (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)). On 05-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not reported. Treatment information was not reported. This case was linked to MOD-2021-211659 (Patient Link).

Other Meds:

Current Illness:

ID: 1644210
Sex: M
Age: 73
State: WV

Vax Date: 04/08/2021
Onset Date: 05/07/2021
Rec V Date: 08/28/2021
Hospital: Y

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: he started choking; he had difficulty in swallowing; He had so much mucous; adverse event that someone else suffered after getting the Moderna vaccine; He has been confused; disoriented; his face was expressionless; This spontaneous case was reported by an other health care professional and describes the occurrence of CHOKING (he started choking), CONFUSIONAL STATE (He has been confused), DISORIENTATION (disoriented), REDUCED FACIAL EXPRESSION (his face was expressionless), DYSPHAGIA (he had difficulty in swallowing), PRODUCTIVE COUGH (He had so much mucous) and VACCINATION COMPLICATION (adverse event that someone else suffered after getting the Moderna vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 021B21A) for COVID-19 vaccination. The patient's past medical history included Tracheostomy, Catheter placement and Percutaneous endoscopic gastrostomy. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced CONFUSIONAL STATE (He has been confused) (seriousness criteria hospitalization, medically significant and life threatening), DISORIENTATION (disoriented) (seriousness criteria hospitalization, medically significant and life threatening) and REDUCED FACIAL EXPRESSION (his face was expressionless) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced CHOKING (he started choking) (seriousness criteria hospitalization, disability, medically significant and life threatening), DYSPHAGIA (he had difficulty in swallowing) (seriousness criteria hospitalization, medically significant and life threatening), PRODUCTIVE COUGH (He had so much mucous) (seriousness criteria hospitalization, medically significant and life threatening) and VACCINATION COMPLICATION (adverse event that someone else suffered after getting the Moderna vaccine) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was hospitalized on 07-May-2021 due to CHOKING, CONFUSIONAL STATE, DISORIENTATION, DYSPHAGIA, PRODUCTIVE COUGH, REDUCED FACIAL EXPRESSION and VACCINATION COMPLICATION. The patient was treated with OXYGEN at an unspecified dose and frequency and Manual therapy (Constant drainage) for Productive cough. At the time of the report, CHOKING (he started choking), CONFUSIONAL STATE (He has been confused), DISORIENTATION (disoriented), REDUCED FACIAL EXPRESSION (his face was expressionless), DYSPHAGIA (he had difficulty in swallowing), PRODUCTIVE COUGH (He had so much mucous) and VACCINATION COMPLICATION (adverse event that someone else suffered after getting the Moderna vaccine) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. The patient did not have any side effects after the first vaccine. The patient was somewhat okay on 08-May-2021. Due to choking, doctors put a tube in him to make him more comfortable. The patient had all kinds of tests (MRI, CAT scan, Lumbar Puncture and Blood work (with unknown results for all)). Due to, so much mucous and constant drainage, the patient was put on a trach tube. The patient was also put in a PEG tube and a catheter as well. He was not getting better and he will not be getting better. The patient was now in extended care/assisted living and his tube feedings had been stopped. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: This case became valid case due to addition of patient identifier (date of birth, age and gender). This case was upgraded to a serious case due to addition of life threatening, disability, hospitalization and medical significant as seriousness criteria. Reporter type, outcome of the event VACCINATION COMPLICATION (adverse event that someone else suffered after getting the Moderna vaccine) and action taken for the suspect were updated. First dose details, second dose batch number, additional serious events and corrective treatment were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644211
Sex: F
Age: 34
State: PA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: chills; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Breast cancer (Left breast cancer). On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site). At the time of the report, CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown. Not provided. No concomitant medications were reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1644212
Sex: F
Age: 74
State: OH

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: light headed; diarrhea; hot around the injection site; hard around the injection site; Fever of 101.5 F; nauseated; headache; very red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site) and PYREXIA (Fever of 101.5 F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site), PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (very red around the injection site). On 20-Mar-2021, DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site), PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (very red around the injection site) had resolved. Patient takes blood pressure medicines but no further information. No concomitant medications are reported by the reporter. No treatment information is provided. This case was linked to MOD-2021-056406, MOD-2021-247019.

Other Meds:

Current Illness:

ID: 1644213
Sex: F
Age:
State: TX

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Rashes that looked like mosquito bites; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes that looked like mosquito bites) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes that looked like mosquito bites). At the time of the report, RASH (Rashes that looked like mosquito bites) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment information not reported. This case was linked to MOD-2021-247929, MOD-2021-247929, MOD-2021-236284 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Reporter stated that she received Pfizer vaccine not a daughter.

Other Meds:

Current Illness:

ID: 1644214
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter; This spontaneous case was reported by a consumer and describes the occurrence of RASH (some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter). At the time of the report, RASH (some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided by the reporter. No treatment information was provided by the reporter. This case was linked to MOD21-115324, MOD-2021-236284, MOD-2021-247899, MOD-2021-247899, MOD-2021-236284 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received included no new information

Other Meds:

Current Illness:

ID: 1644215
Sex: F
Age: 36
State: NY

Vax Date: 04/23/2021
Onset Date: 04/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Nauseous; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired) and NAUSEA (Nauseous) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. Medical history is not reported. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced FATIGUE (Really tired). On 28-Apr-2021, the patient experienced NAUSEA (Nauseous). On 28-Apr-2021, FATIGUE (Really tired) and NAUSEA (Nauseous) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product used by the patient includes MULTIVITAMIN for an unknown indication. No Treatment medication were reported. This case was linked to MOD-2021-248381 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-Jul-2021 and contains no new information. On 09-Aug-2021: Follow-up received on 09-AUG-2021 included no new information.

Other Meds: XANAX

Current Illness:

ID: 1644216
Sex: M
Age:
State: IN

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Sore arm; Didn't feel right; Slight body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concomitant products included DOXYCYCLINE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-031627 (Patient Link).

Other Meds: DOXYCYCLINE

Current Illness:

ID: 1644217
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Getting COVID 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Getting COVID After the Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Getting COVID After the Vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided by the reporter. No treatment information was reported by the reporter.

Other Meds:

Current Illness:

ID: 1644218
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Why does a magnet stick to my injection sight?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?) 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 SITE REACTION (Why does a magnet stick to my injection sight?). At the time of the report, VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided No treatment medications were provided

Other Meds:

Current Illness:

ID: 1644219
Sex: U
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: doesn't want to receive the second dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication not provided. Treatment medication not provided

Other Meds:

Current Illness:

ID: 1644220
Sex: M
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: chest CT; Result Unstructured Data: Negative for Pulmonary embolismQ; Test Date: 2021; Test Name: CRP; Result Unstructured Data: 6.32 mg/dl; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Diffuse ST elevation, PR depression; Test Date: 2021; Test Name: cardiac MRI; Result Unstructured Data: LVEF: 53% Regional wall motion abnormality present, traces of Pericardial effusion present, pericardial thickness is normal. late gadolinium enhancement present at apical lateral region, showed epicardial myocardial pattern.; Test Date: 2021; Test Name: ESR; Test Result: Inconclusive ; Result Unstructured Data: 6 mm/h; Test Date: 2021; Test Name: COVID -19 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: Peak troponin; Result Unstructured Data: hs-Tn T: 230 ng/l; Test Date: 2021; Test Name: Respiratory virus PCR; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: WBC; Result Unstructured Data: 10, 200/ul

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis), DYSPNOEA (Shortness of breath) and CHEST PAIN (Severe chest pain) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), CHEST PAIN (Severe chest pain) (seriousness criterion hospitalization), VACCINATION SITE DISCOMFORT (Injection site discomfort), FATIGUE (Fatigue), MYALGIA (muscle ache), PYREXIA (Fever) and CHILLS (chills). The patient was treated with COLCHICINE for Myocarditis, at an unspecified dose and frequency and NSAIDS for Myocarditis, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Acute myocarditis), DYSPNOEA (Shortness of breath), CHEST PAIN (Severe chest pain), VACCINATION SITE DISCOMFORT (Injection site discomfort), FATIGUE (Fatigue), MYALGIA (muscle ache), PYREXIA (Fever) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 6.32 mg/dl (abnormal) 6.32 mg/dl. In 2021, Computerised tomogram thorax: negative for pe (normal) Negative for Pulmonary embolismQ. In 2021, Electrocardiogram: diffuse st elevation (abnormal) Diffuse ST elevation, PR depression. In 2021, Magnetic resonance imaging heart: abnormal (abnormal) LVEF: 53% Regional wall motion abnormality present, traces of Pericardial effusion present, pericardial thickness is normal. late gadolinium enhancement present at apical lateral region, showed epicardial myocardial pattern.. In 2021, Red blood cell sedimentation rate: 6 mm/h (Inconclusive) 6 mm/h. In 2021, SARS-CoV-2 test: negative (Negative) Negative. In 2021, Troponin T: hs-tn t: 230 ng/l (abnormal) hs-Tn T: 230 ng/l. In 2021, Viral test: negative (Negative) Negative. In 2021, White blood cell count: 10, 200/ul (normal) 10, 200/ul. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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. This case was linked to MOD-2021-249585 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type was updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article received with no new information.

Other Meds:

Current Illness:

ID: 1644221
Sex: F
Age: 83
State: CA

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore shoulder- Left; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder- Left) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder- Left). At the time of the report, ARTHRALGIA (Sore shoulder- Left) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments No concomitant medication information was provided. No treatment medication were provided. This case was linked to MOD-2021-058103 (Patient Link).

Other Meds:

Current Illness:

ID: 1644222
Sex: F
Age: 17
State: TX

Vax Date: 06/06/2021
Onset Date: 06/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Off-Label Use (Under Age); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-Label Use (Under Age)) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. Patient medical history was not provided. Concomitant products included ALBUTEROL [SALBUTAMOL], VENLAFAXINE HYDROCHLORIDE (EFEXOR) and VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE XR) for an unknown indication. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-Label Use (Under Age)). On 06-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-Label Use (Under Age)) 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 treatment information was provided. This case was linked to MOD-2021-265390 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non significant follow-up appended : No new information added related to first dose.

Other Meds: ALBUTEROL [SALBUTAMOL]; EFEXOR; VENLAFAXINE XR

Current Illness:

ID: 1644223
Sex: F
Age: 84
State: NJ

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Side effect on the face; Swollen,it got bigger; Sort of dark looking\ side effect on her face and skin which is dark looking; It was very upsetting; Damage to their face; Damage to their skin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting) and FACE INJURY (Damage to their face) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-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 VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin). At the time of the report, VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin) outcome was unknown. No treatment medication details was reported. This case was linked to MOD-2021-250415 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and patient's contact details added, updated event information. On 10-Aug-2021: Follow -up received on 10-AUG-2021 contains Non Significant information On 12-Aug-2021: follow-up received and additional AE added.

Other Meds: SYNTHROID

Current Illness:

ID: 1644224
Sex: F
Age: 51
State: NY

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swollen arm for days; had a high fever 14 hours after shot; very bad headache; tired; sore arm couldn't lift it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm couldn't lift it), PERIPHERAL SWELLING (swollen arm for days), FATIGUE (tired), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE (HCT) and ALPRAZOLAM (XANAX) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm couldn't lift it) and FATIGUE (tired). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm for days), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm couldn't lift it) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm for days), FATIGUE (tired), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient felt normal after 48 hours of shot and as of present day had no residual effects. This case was linked to MOD-2021-016075. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received included E-mail, event outcome and added events.

Other Meds: VALSARTAN; ATORVASTATIN; HCT; XANAX

Current Illness:

ID: 1644225
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccination site pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) had resolved. Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-073354, MOD-2021-073354 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644226
Sex: F
Age: 64
State: LA

Vax Date: 06/29/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Patient administered dose before recommended scheduled vaccine date; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment information were reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received and does not contain any new information.

Other Meds:

Current Illness:

ID: 1644227
Sex: M
Age: 81
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: redness at the injection site /Redness at the injection site 2-3 days after both the 1st and 2nd doses.; Soreness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site /Redness at the injection site 2-3 days after both the 1st and 2nd doses.), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The patient's past medical history included Inflammation. Concurrent medical conditions included Diabetes mellitus (non-insulin dependent diabetes mellitus) and Hypertension. Concomitant products included PREDNISONE for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site /Redness at the injection site 2-3 days after both the 1st and 2nd doses.), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 18-Feb-2021, VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved. On 19-Feb-2021, VACCINATION SITE ERYTHEMA (redness at the injection site /Redness at the injection site 2-3 days after both the 1st and 2nd doses.) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details were not reported by the reporter. This case was linked to MOD-2021-251792 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: significant follow up : added medical history and concomitant medication, updated stop date of events of vaccination site swelling and vaccination site pain

Other Meds: PREDNISONE

Current Illness: Diabetes mellitus (non-insulin dependent diabetes mellitus); Hypertension

ID: 1644228
Sex: M
Age: 81
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: redness at the injection site; soreness at the injection site; swelling at the injection site; soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site), INJECTION SITE SWELLING (swelling at the injection site), MYALGIA (soreness) and SWELLING (swelling) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus non-insulin-dependent, Blood pressure high and Inflammation. Concomitant products included PREDNISONE for an unknown indication. 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) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (soreness) and SWELLING (swelling). On 16-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site). On 18-Feb-2021, MYALGIA (soreness) and SWELLING (swelling) had resolved. On 19-Mar-2021, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: follow up received includes Patient medical history, concomitant medication, events updated.

Other Meds: PREDNISONE

Current Illness: Blood pressure high; Diabetes mellitus non-insulin-dependent; Inflammation

ID: 1644229
Sex: F
Age: 71
State: FL

Vax Date: 02/07/2021
Onset Date: 02/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: joint pains in her neck, hips, back, thighs, and waist; joint pains in her neck, hips, back, thighs, and waist; joint pains in her neck, hips, back, thighs, and waist; dry eyes; redness at the injection site; soreness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (joint pains in her neck, hips, back, thighs, and waist), NECK PAIN (joint pains in her neck, hips, back, thighs, and waist), DRY EYE (dry eyes), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Family history included Sjogren's syndrome (Family history includes Sjogren's syndrome (her mother.) Concurrent medical conditions included Chronic lymphocytic leukemia (in remission) (She was being treated for her CLL in JUL2018 to NOV2018 with CD20 targeting medications .), Osteoporosis and COPD. Concomitant products included ACYCLOVIR [ACICLOVIR], RITUXIMAB and OBINUTUZUMAB (GAZYVA) for an unknown indication. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 21-Feb-2021, the patient experienced DRY EYE (dry eyes). On an unknown date, the patient experienced BACK PAIN (joint pains in her neck, hips, back, thighs, and waist), NECK PAIN (joint pains in her neck, hips, back, thighs, and waist) and ARTHRALGIA (joint pains in her neck, hips, back, thighs, and waist). On 10-Feb-2021, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved. At the time of the report, BACK PAIN (joint pains in her neck, hips, back, thighs, and waist), NECK PAIN (joint pains in her neck, hips, back, thighs, and waist) and ARTHRALGIA (joint pains in her neck, hips, back, thighs, and waist) outcome was unknown and DRY EYE (dry eyes) had not resolved. Patient current testing reveals a 1.0 response for antibodies using a SARS-COV-2 AB test and a semiquantitative test showed 1/10 . Treatment information was provided i.e., eye drops. This case was linked to MOD-2021-251807 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: significant follow up received on 10-AUG-2021 contains new information. Current medications added. Lab data added in I narrative .Patient historical vaccines added.Concomitant medications added.

Other Meds: ACYCLOVIR [ACICLOVIR]; RITUXIMAB; GAZYVA.

Current Illness: Chronic lymphocytic leukemia (in remission) (She was being treated for her CLL in JUL2018 to NOV2018 with CD20 targeting medications .); COPD; Osteoporosis.

ID: 1644230
Sex: F
Age: 36
State: IL

Vax Date: 07/10/2021
Onset Date: 07/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Arm pain after getting their first dose of the Moderna covid19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after getting their first dose of the Moderna covid19) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0331521a) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesterolemia, Blood pressure and Diabetic. Concomitant products included ATORVASTATIN, LISINOPRIL and EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) for an unknown indication. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced PAIN IN EXTREMITY (Arm pain after getting their first dose of the Moderna covid19). At the time of the report, PAIN IN EXTREMITY (Arm pain after getting their first dose of the Moderna covid19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication was not reported. Reporter mentioned that patient stopped taking concomitant medications five days prior to vaccination and didn't specified the motive for this decision. Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up received on 11-JUL-2021 is not significant. Event verbatim is changed but the PT term remains the same.

Other Meds: ATORVASTATIN; LISINOPRIL; SYNJARDY

Current Illness: Blood pressure; Diabetic; Hypercholesterolemia

ID: 1644231
Sex: F
Age:
State: PA

Vax Date: 02/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sweating overnight; Chills; arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Drug allergy (Allergic to neomycin). Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and LEVALBUTEROL [LEVOSALBUTAMOL] for Asthma. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia). On 18-Mar-2021, HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia) had resolved. Concomitant included vitamins was noted. No treatment information was provided by the reporter. This case was linked to MOD-2021-022028 (Patient Link).

Other Meds: SYMBICORT; NASACORT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVALBUTEROL [LEVOSALBUTAMOL]

Current Illness: Asthma; Drug allergy (Allergic to neomycin)

ID: 1644232
Sex: F
Age:
State: MA

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Blisters; three different adverse effects; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters) and ADVERSE REACTION (three different adverse effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included High cholesterol (has not taken medication for it). Concomitant products included VITAMIN D NOS for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 BLISTER (Blisters) and ADVERSE REACTION (three different adverse effects). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, BLISTER (Blisters) and ADVERSE REACTION (three different adverse effects) outcome was unknown. Concomitant medications also included Vitamin D deficiency medications and pain medications. Other Treatment information includes Neosporin and it dissipated for first incidence , Lysol wipes, A1 bleach on skin. Patient have had three different adverse effects on body and was now dealing with the third. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU-Event provided On 14-Aug-2021: FU added:events images On 14-Aug-2021: Follow-up 5 received event images. On 18-Aug-2021: NNI FU: no new information On 20-Aug-2021: Follow up received and contains no new information.

Other Meds: VITAMIN D NOS

Current Illness:

ID: 1644233
Sex: F
Age: 67
State: NC

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: 2 insect looking bites on buttocks; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (2 insect looking bites on buttocks) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included METHOTREXATE, FOLIC ACID, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and TRIAMCINOLONE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHROPOD BITE (2 insect looking bites on buttocks). At the time of the report, ARTHROPOD BITE (2 insect looking bites on buttocks) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Other concomitant medications were Benadryl Gel and triamcinolone cream. No treatment medication was provided Patient stated that she had 2 insect looking bites on the back of her buttocks that went away after taking an antihistamine. Patient stated that she completed the form but don't know how to return it via email. Patient printed it out and copied it if you can send an actual address to mail it. This case was linked to MOD-2021-254162 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: Non significant follow up received and does not contain any new information

Other Meds: METHOTREXATE; FOLIC ACID; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; TRIAMCINOLONE

Current Illness: Diabetes

ID: 1644234
Sex: M
Age:
State: IL

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 17 year old received first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) 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 medications were reported. This case was linked to MOD-2021-254000 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant information Appended. 2nd dose details provided .

Other Meds:

Current Illness:

ID: 1644235
Sex: F
Age:
State: CA

Vax Date: 04/13/2021
Onset Date: 05/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizziness; Allergic red rash at the injection site/the rash is not itchy and painful; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) and PYREXIA (Little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 031B21A) for COVID-19 vaccination. Patient medical history was not reported. Concomitant products included FISH OIL for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) and PYREXIA (Little fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness) and PYREXIA (Little fever) outcome was unknown and VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) was resolving. Patient reported that on the same day of the second vaccination, she developed fever and dizziness. Two to three hours after the second shot she noticed an allergic red rash at the injection site. The following day on 12-MAY-2021 she visited Urgent Care who advised to wait for two days and the rash would disappear by itself. Patient took Ibuprofen for the symptoms. The rash was persisting and the patient was quoted, "I want a clean hand. " The rash was not itchy nor painful. The concern was if the symptoms were normal adverse reactions after receiving the Moderna vaccine and what she should do since the rash was persisting. This case was linked to MOD-2021-133429 (Patient Link).

Other Meds: FISH OIL

Current Illness:

ID: 1644236
Sex: U
Age:
State: CA

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: The nurse inadvertently administered 1ml instead of 0.5ml; 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 ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml). On 27-Apr-2021, ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml) 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 treatment medication was provided. This case was linked to MOD-2021-092554, MOD-2021-092190 (Patient Link).

Other Meds:

Current Illness:

ID: 1644237
Sex: F
Age: 57
State: NJ

Vax Date: 05/22/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210728; Test Name: Colonoscopy; Result Unstructured Data: Lymphocytic colitis; Test Date: 20210713; Test Name: stool; Result Unstructured Data: no infection.

Allergies:

Symptom List: Vomiting

Symptoms: Lymphocytic colitis; severe diarrhea; Tiredness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COLITIS MICROSCOPIC (Lymphocytic colitis) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (Augmentin). Concomitant products included MULTIVITAMIN [VITAMINS NOS], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication. On 22-May-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced DIARRHEA (severe diarrhea) and FATIGUE (Tiredness). On 28-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLITIS MICROSCOPIC (Lymphocytic colitis) (seriousness criterion medically significant). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date at an unspecified dose and frequency and BUDESONIDE for Adverse event, at a dose of two weeks. At the time of the report, COLITIS MICROSCOPIC (Lymphocytic colitis) and DIARRHEA (severe diarrhea) had not resolved and FATIGUE (Tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Stool analysis: normal (normal) no infection. On 28-Jul-2021, Colonoscopy: abnormal (abnormal) Lymphocytic colitis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Updated reporter information, patient demographics, Added medical history, Lab data, updated,concomitant ,Vaccination facility information, Event onset date; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: MULTIVITAMIN [VITAMINS NOS]; B12 [CYANOCOBALAMIN]; TURMERIC [CURCUMA LONGA]

Current Illness: Allergy to antibiotic (Augmentin).

ID: 1644238
Sex: F
Age: 57
State: TX

Vax Date: 05/08/2021
Onset Date: 06/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms; pain like pins and needles poking all over; Tightening between the ball and heel of her left foot; atrophy in feet; Mild headache; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot), ATROPHY (atrophy in feet) and HEADACHE (Mild headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History was reported. Concomitant products included MAGNESIUM for Muscle disorder NOS, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, VITAMIN B1 NOS (B COMPLEX [NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS]) for Nerve injury, MULTIVITAMIN [VITAMINS NOS], RETINOL (VITAMIN-A), ASCORBIC ACID (VITAMIN-C), VITAMIN B NOS, VITAMIN E NOS (VITAMIIN E), ZINC, MILK OF MAGNESIA and VITAMIN D NOS for an unknown indication. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced HEADACHE (Mild headache) and FATIGUE (Extremely tired). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) and ATROPHY (atrophy in feet). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at a dose of 100 mg; GABAPENTIN at a dose of 100 mg; MAGNESIUM SULFATE (EPSOM SALT) for Adverse event, at an unspecified dose and frequency and Physical therapy (Exercises on own) for Hypoaesthesia. At the time of the report, HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), ATROPHY (atrophy in feet), HEADACHE (Mild headache) and FATIGUE (Extremely tired) had not resolved and PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) outcome was unknown. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added treatment medications Aspirin & Gabapentin and new events. On 02-Aug-2021: Added New event atrophy in feet and concomitant medications On 13-Aug-2021: Significant TCR received. case updated to not recovered/Not resolved

Other Meds: MULTIVITAMIN [VITAMINS NOS]; VITAMIN-A; VITAMIN-C; VITAMIN B NOS; VITAMIIN E; ZINC; MILK OF MAGNESIA; VITAMIN D NOS; MAGNESIUM; B COMPLEX [NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS]

Current Illness:

ID: 1644239
Sex: F
Age:
State: AZ

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20201224; Test Name: covid-19 test; Test Result: Positive ; Result Unstructured Data: positive; Test Date: 20201224; Test Name: sinus; Result Unstructured Data: right sinus examined with scope- looked ok

Allergies:

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

Symptoms: cough still like covid mucous in bronchial tubes; cough still like covid mucous in bronchial tubes; Tired than ususal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 041B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Drug allergy (allergy to oxysporein drugs in antibiotic), Anaphylaxis (Full blown anaphylaxis on tablet) since June 2012, Autoimmune thyroid disorder since 15-Jun-2014, Arthritis and Hypertension. Concomitant products included HYDROXYCHLOROQUINE from 04-Sep-2019 to an unknown date and DULOXETINE from 19-Jun-2019 to an unknown date for Arthritis, LISINOPRIL for Blood pressure management, LIOTHYRONINE for Hypothyroidism, LEVOTHYROXINE for Thyroid activity decreased, PARACETAMOL (TYLENOL) and VIT D [VITAMIN D NOS] for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal). The patient was treated with IPRATROPIUM BROMIDE at a dose of nasal solution. At the time of the report, COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test:. On an unknown date, Sinoscopy: normal (normal) right sinus examined with scope- looked ok. This case was linked to MOD-2021-053063 (Patient Link).

Other Meds: LEVOTHYROXINE; LIOTHYRONINE; HYDROXYCHLOROQUINE; DULOXETINE; LISINOPRIL; TYLENOL; VIT D [VITAMIN D NOS]

Current Illness: Anaphylaxis (Full blown anaphylaxis on tablet); Arthritis; Autoimmune thyroid disorder; Drug allergy (allergy to oxysporein drugs in antibiotic); Hypertension

ID: 1644240
Sex: F
Age: 45
State: MA

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: My right foot felt like it was asleep; Tingling in her right leg; rash on her right leg; More than 35 days since the patient received her first Moderna Covid-19 vaccine; Tinnitus; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), TINNITUS (Tinnitus), PARAESTHESIA (Tingling in her right leg) and RASH (rash on her right leg) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 22-Apr-2021, the patient experienced TINNITUS (Tinnitus). On 23-Apr-2021, the patient experienced PARAESTHESIA (Tingling in her right leg), RASH (rash on her right leg) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since the patient received her first Moderna Covid-19 vaccine). On an unknown date, the patient experienced HYPOAESTHESIA (My right foot felt like it was asleep). At the time of the report, PYREXIA (Fever), CHILLS (Chills), TINNITUS (Tinnitus), PARAESTHESIA (Tingling in her right leg), RASH (rash on her right leg), PRODUCT DOSE OMISSION ISSUE (More than 35 days since the patient received her first Moderna Covid-19 vaccine) and HYPOAESTHESIA (My right foot felt like it was asleep) outcome was unknown. 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 treatment drugs included no concomitant drugs included

Other Meds:

Current Illness:

ID: 1644241
Sex: M
Age:
State:

Vax Date: 03/15/2021
Onset Date: 04/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: more than 36 days since got the first dose; 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 (more than 36 days since got the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644242
Sex: U
Age:
State:

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received a dose on day 34 of refrigeration, 4 days over use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Additional information received included that the vials were stored in liquid state for 34 days from 3C to 5C and only exposed to 70F for 30 minutes during administration. Upon visual inspection, the vaccine looked normal. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received on 15-Jul-2021 and included reporter details, suspect vaccine details and updated to events.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am