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: 1695379
Sex: F
Age: 71
State: FL

Vax Date: 01/21/2021
Onset Date: 01/25/2021
Rec V Date: 09/13/2021
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: arthritis in my joints; pain in my arms; It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis in my joints), PAIN IN EXTREMITY (pain in my arms) and MYALGIA (It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced ARTHRITIS (arthritis in my joints), PAIN IN EXTREMITY (pain in my arms) and MYALGIA (It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm). At the time of the report, ARTHRITIS (arthritis in my joints), PAIN IN EXTREMITY (pain in my arms) and MYALGIA (It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was stated The patient has always exercised regularly. Prior to receiving the vaccine, patient was doing 100 pushups several times a week. She was using an 8 lb weight to bend over and up strengthening her arms. patient did a walk/run about three miles several times a week. No Concomitant medication was provided. No Treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up information include patient demographics details, new events, event start date and outcome updated.

Other Meds:

Current Illness:

ID: 1695380
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Reported a side effect; I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reported a side effect) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reported a side effect) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND). At the time of the report, VACCINATION COMPLICATION (Reported a side effect) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND) had resolved. No concomitant medication was reported. No treatment medication was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695381
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Can I start feeling side effects an hour after the 2nd dose?; Can I get sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Can I start feeling side effects an hour after the 2nd dose?) and ILLNESS (Can I get sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 (Can I start feeling side effects an hour after the 2nd dose?) and ILLNESS (Can I get sick). At the time of the report, VACCINATION COMPLICATION (Can I start feeling side effects an hour after the 2nd dose?) and ILLNESS (Can I get sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported by reporter. Treatment information was not provided by reporter

Other Meds:

Current Illness:

ID: 1695382
Sex: U
Age:
State: WA

Vax Date: 07/29/2021
Onset Date:
Rec V Date: 09/13/2021
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: covid arm; soreness with red and hot muscle; soreness with red and hot muscle; rash down the arm; soreness with red and hot muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), ERYTHEMA (soreness with red and hot muscle), FEELING HOT (soreness with red and hot muscle), RASH (rash down the arm) and MYALGIA (soreness with red and hot muscle) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm), ERYTHEMA (soreness with red and hot muscle), FEELING HOT (soreness with red and hot muscle), RASH (rash down the arm) and MYALGIA (soreness with red and hot muscle). At the time of the report, VACCINATION SITE REACTION (covid arm), ERYTHEMA (soreness with red and hot muscle), FEELING HOT (soreness with red and hot muscle), RASH (rash down the arm) and MYALGIA (soreness with red and hot muscle) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. This case was linked to MOD-2021-302001 (Patient Link).

Other Meds:

Current Illness:

ID: 1695383
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Residual numbness in my cheeks; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Residual numbness in my cheeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Residual numbness in my cheeks). At the time of the report, HYPOAESTHESIA (Residual numbness in my cheeks) outcome was unknown. No concomitant medication were provided by reporter. No treatment details were provided by reporter.

Other Meds:

Current Illness:

ID: 1695384
Sex: M
Age: 70
State: CA

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: Body temperature; Result Unstructured Data: a fever of 100.9?F.

Allergies:

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

Symptoms: Felt like I had the flu; Fever/ up to 100.9/ febrile for close to 24 hours; Chills; Body aches; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I had the flu), PYREXIA (Fever/ up to 100.9/ febrile for close to 24 hours), CHILLS (Chills) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The patient's past medical history included Exposure to mold (has previously been exposed to black mold). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I had the flu), PYREXIA (Fever/ up to 100.9/ febrile for close to 24 hours), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1500 mg every eight hours. In February 2021, INFLUENZA LIKE ILLNESS (Felt like I had the flu), PYREXIA (Fever/ up to 100.9/ febrile for close to 24 hours), CHILLS (Chills) and MYALGIA (Body aches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: up to 100.9?f. (High) a fever of 100.9?F.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The Patient is on Type 2 Diabetic medication. This case was linked to MOD-2021-301965, MOD-2021-302003 (Patient Link).

Other Meds:

Current Illness: Asthma; Type 2 diabetes mellitus

ID: 1695385
Sex: F
Age:
State: OH

Vax Date: 04/23/2021
Onset Date: 08/27/2021
Rec V Date: 09/13/2021
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: Patient was upset /very upset about the uncertainty of her condition; Rash like a big spot; Swelling on lymph nodes; Arm pit became tender; Mental state was distressed; Skin was peeling off; Sensation of a scar; Arm pit became red; Arm pit became hot and irritated; COVID19 vaccine activated the cancer cells; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (Mental state was distressed), SKIN EXFOLIATION (Skin was peeling off), SCAR PAIN (Sensation of a scar), ERYTHEMA (Arm pit became red) and FEELING HOT (Arm pit became hot and irritated) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 02XC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mastectomy bilateral in 2013 and Lymph node dissection (2 lymph nodes which were benign.). Concurrent medical conditions included Breast cancer NOS recurrent (affected on 1% of patients who had a bilateral mastectomy) since March 2015. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced EMOTIONAL DISTRESS (Mental state was distressed), SKIN EXFOLIATION (Skin was peeling off), SCAR PAIN (Sensation of a scar), ERYTHEMA (Arm pit became red), FEELING HOT (Arm pit became hot and irritated), VACCINATION COMPLICATION (COVID19 vaccine activated the cancer cells), RASH (Rash like a big spot), LYMPHADENOPATHY (Swelling on lymph nodes) and AXILLARY PAIN (Arm pit became tender). On an unknown date, the patient experienced DEPRESSED MOOD (Patient was upset /very upset about the uncertainty of her condition). At the time of the report, EMOTIONAL DISTRESS (Mental state was distressed), SKIN EXFOLIATION (Skin was peeling off), SCAR PAIN (Sensation of a scar), ERYTHEMA (Arm pit became red), FEELING HOT (Arm pit became hot and irritated), VACCINATION COMPLICATION (COVID19 vaccine activated the cancer cells), RASH (Rash like a big spot), LYMPHADENOPATHY (Swelling on lymph nodes) and AXILLARY PAIN (Arm pit became tender) had not resolved and DEPRESSED MOOD (Patient was upset /very upset about the uncertainty of her condition) outcome was unknown. Patient stated took concomitant medications of breast cancer medication and since 2016 and took ultrasound test. Patient suggested the COVID19 vaccine activated the cancer cells, that she was on remission and that she wasn't sure that the vaccine was safe for cancer patients and that she didn't want her lymph nodes to be bothered. No treatment medications were provided by reporter.

Other Meds:

Current Illness: Breast cancer NOS recurrent (affected on 1% of patients who had a bilateral mastectomy)

ID: 1695386
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Are is sre at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Are is sre at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Prostate cancer. In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Are is sre at injection site). At the time of the report, MYALGIA (Are is sre at injection site) outcome was unknown. No Concomitant medication information was reported. No treatment medications were provided. This case was linked to MOD-2021-301904 (Patient Link).

Other Meds:

Current Illness: Arthritis; Prostate cancer

ID: 1695387
Sex: M
Age: 27
State: CO

Vax Date: 07/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/13/2021
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: The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Intellectual disability, Schizophrenia and Vitamin D deficiency. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021 at 11:50 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM). On 27-Aug-2021 at 11:50 AM, EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not reported. Reporter also states that The patient did not report any other adverse reactions after the first or the second dose of Moderna Covid-19 vaccine. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up information included patient details, past medical history and vaccine dose details.

Other Meds:

Current Illness: Asthma; Intellectual disability; Schizophrenia; Vitamin D deficiency

ID: 1695388
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Really weird adverse reaction/weird side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Really weird adverse reaction/weird side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Really weird adverse reaction/weird side effect). At the time of the report, VACCINATION COMPLICATION (Really weird adverse reaction/weird side effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not reported. Treatment medication were not reported. Patient got the Moderna vaccine Saturday morning and was having a really weird adverse reaction, a weird side effect.

Other Meds:

Current Illness:

ID: 1695389
Sex: M
Age: 63
State: FL

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The patient's past medical history included Eczema since an unknown date. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced PAIN IN EXTREMITY (Soreness on the arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. This case was linked to MOD-2021-302087 (Patient Link).

Other Meds: DUPIXENT

Current Illness:

ID: 1695390
Sex: F
Age: 66
State: FL

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Cough; Spiked proteins; Body aches; A low grade fever; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Cough), SUSPECTED COVID-19 (Spiked proteins), MYALGIA (Body aches) and PYREXIA (A low grade fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), WARFARIN SODIUM (COUMADIN), OMEPRAZOLE and LEVOTHYROXINE for an unknown indication. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), SUSPECTED COVID-19 (Spiked proteins), MYALGIA (Body aches) and PYREXIA (A low grade fever). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, COUGH (Cough) and SUSPECTED COVID-19 (Spiked proteins) outcome was unknown and MYALGIA (Body aches) and PYREXIA (A low grade fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-301941 (Patient Link).

Other Meds: BYSTOLIC; CELEXA [CITALOPRAM HYDROBROMIDE]; COUMADIN; OMEPRAZOLE; LEVOTHYROXINE

Current Illness:

ID: 1695391
Sex: F
Age: 63
State: CT

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: got tired after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (got tired after the first vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (got tired after the first vaccine). At the time of the report, FATIGUE (got tired after the first vaccine) outcome was unknown. No treatment details were provided by reporter. Her blood test from 20-Aug-2021 shows that she has 0.4 non-detectable SARS-Co-V-2 antibodies . This case was linked to MOD-2021-302110.

Other Meds: OCREVUS

Current Illness: Multiple sclerosis

ID: 1695392
Sex: F
Age: 63
State: CT

Vax Date: 03/10/2021
Onset Date: 04/07/2021
Rec V Date: 09/13/2021
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: 20210820; Test Name: Blood tests; Test Result: Inconclusive ; Result Unstructured Data: 0.4 non-detectable SARS-Co-V-2 antibodies IgM present.

Allergies:

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

Symptoms: miserable/I was pretty much incapacitated for about 28 hours; excruciating pain; incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch; Scared to get the third shot; did vomit; very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable/I was pretty much incapacitated for about 28 hours), PAIN (excruciating pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch), FEAR (Scared to get the third shot) and VOMITING (did vomit) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (miserable/I was pretty much incapacitated for about 28 hours), PAIN (excruciating pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch), FEAR (Scared to get the third shot), VOMITING (did vomit) and NAUSEA (very nauseous). At the time of the report, FEELING ABNORMAL (miserable/I was pretty much incapacitated for about 28 hours), PAIN (excruciating pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch), FEAR (Scared to get the third shot), VOMITING (did vomit) and NAUSEA (very nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Blood test: 0.4 (Inconclusive) 0.4 non-detectable SARS-Co-V-2 antibodies IgM present.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication was not reported. 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. This case was linked to MOD-2021-302102 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: OCREVUS

Current Illness: Multiple sclerosis

ID: 1695393
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1695394
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Lethargy after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy after receiving Moderna vaccine) 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 LETHARGY (Lethargy after receiving Moderna vaccine). At the time of the report, LETHARGY (Lethargy after receiving Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received contains no new information.

Other Meds:

Current Illness:

ID: 1695395
Sex: F
Age: 80
State: NY

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 09/13/2021
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: Arm was itching; Arm was hard; Arm was swollen; Arm became red / Sunday her arm was much redder; She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A), VACCINATION SITE PRURITUS (Arm was itching), VACCINATION SITE INDURATION (Arm was hard), VACCINATION SITE ERYTHEMA (Arm became red / Sunday her arm was much redder) and VACCINATION SITE SWELLING (Arm was swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A). On 27-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm became red / Sunday her arm was much redder). On 29-Aug-2021, the patient experienced VACCINATION SITE INDURATION (Arm was hard) and VACCINATION SITE SWELLING (Arm was swollen). On 30-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Arm was itching). On 27-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 2nd dose 28Jan2021 (lot was accidentally deleted) and her 3rd dose 27Aug2021 Lot 088D21A) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm was itching), VACCINATION SITE INDURATION (Arm was hard), VACCINATION SITE ERYTHEMA (Arm became red / Sunday her arm was much redder) and VACCINATION SITE SWELLING (Arm was swollen) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1695396
Sex: M
Age: 61
State: NJ

Vax Date: 07/12/2021
Onset Date: 08/30/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Missed the second shot 48 days post first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second shot 48 days post first vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second shot 48 days post first vaccine). On 30-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Missed the second shot 48 days post first vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was reported. The patient was yet to received second dose.

Other Meds:

Current Illness:

ID: 1695397
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Chest pain after taking Moderna; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain after taking Moderna) 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 CHEST PAIN (Chest pain after taking Moderna). At the time of the report, CHEST PAIN (Chest pain after taking Moderna) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided by the reporter. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1695398
Sex: F
Age: 59
State: MN

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/13/2021
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: Expired vaccine given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported by reporter. Treatment information was not provided by reporter.

Other Meds:

Current Illness:

ID: 1695399
Sex: M
Age: 60
State: NH

Vax Date: 04/28/2021
Onset Date: 08/30/2021
Rec V Date: 09/13/2021
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: Got his second dose few months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got his second dose few months after the first dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got his second dose few months after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got his second dose few months after the first dose) had resolved. No concomitant product use was provided by the reporter. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1695400
Sex: F
Age: 43
State: FL

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/13/2021
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: swelling in my hands /swelling in my feet; swelling in both knees; since the vaccine my joints have been aching; dizziness; my arms and chest turned itchy; my arms and chest turned bright red; nausea; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), PRURITUS (my arms and chest turned itchy), ERYTHEMA (my arms and chest turned bright red), SWELLING (swelling in my hands /swelling in my feet) and JOINT SWELLING (swelling in both knees) in a 43-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. Concomitant products included DIPHENHYDRAMINE, NAPROXEN and PREDNISONE for an unknown indication. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced DIZZINESS (dizziness), PRURITUS (my arms and chest turned itchy), ERYTHEMA (my arms and chest turned bright red), NAUSEA (nausea) and CHILLS (chills). On an unknown date, the patient experienced SWELLING (swelling in my hands /swelling in my feet), JOINT SWELLING (swelling in both knees) and ARTHRALGIA (since the vaccine my joints have been aching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Joint pain, at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), PRURITUS (my arms and chest turned itchy), ERYTHEMA (my arms and chest turned bright red), SWELLING (swelling in my hands /swelling in my feet), JOINT SWELLING (swelling in both knees), NAUSEA (nausea), CHILLS (chills) and ARTHRALGIA (since the vaccine my joints have been aching) 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.

Other Meds: DIPHENHYDRAMINE; NAPROXEN; PREDNISONE

Current Illness:

ID: 1695401
Sex: M
Age: 61
State: PA

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 09/13/2021
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: severe chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (severe chills). At the time of the report, CHILLS (severe chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-302223 (Patient Link).

Other Meds:

Current Illness:

ID: 1695402
Sex: F
Age: 46
State: NC

Vax Date: 08/30/2021
Onset Date:
Rec V Date: 09/13/2021
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: 2nd dose, feel bad; 2nd dose, very short of breath; 2nd dose could not move arm; 2nd dose sweats; 2nd dose cold; 2nd dose, do not feel good at all; 2nd dose, feel like throwing up; 2nd dose, bad headache/terrible headache; 2nd dose, arm sore right after shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (2nd dose, feel bad), DYSPNOEA (2nd dose, very short of breath), VACCINATION SITE MOVEMENT IMPAIRMENT (2nd dose could not move arm), HYPERHIDROSIS (2nd dose sweats) and FEELING COLD (2nd dose cold) in a 46-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. On 30-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (2nd dose, feel bad), DYSPNOEA (2nd dose, very short of breath), VACCINATION SITE MOVEMENT IMPAIRMENT (2nd dose could not move arm), HYPERHIDROSIS (2nd dose sweats), FEELING COLD (2nd dose cold), VACCINATION COMPLICATION (2nd dose, do not feel good at all), NAUSEA (2nd dose, feel like throwing up), HEADACHE (2nd dose, bad headache/terrible headache) and PAIN IN EXTREMITY (2nd dose, arm sore right after shot). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 2 tablets,every 4hrs. At the time of the report, FEELING ABNORMAL (2nd dose, feel bad), DYSPNOEA (2nd dose, very short of breath), VACCINATION SITE MOVEMENT IMPAIRMENT (2nd dose could not move arm), HYPERHIDROSIS (2nd dose sweats), FEELING COLD (2nd dose cold), VACCINATION COMPLICATION (2nd dose, do not feel good at all), NAUSEA (2nd dose, feel like throwing up) and PAIN IN EXTREMITY (2nd dose, arm sore right after shot) outcome was unknown and HEADACHE (2nd dose, bad headache/terrible headache) had not resolved. Concomitant product use was not provided by the reporter. Patient took 2 tablets of Advil every 4 hours, and the headache still didn't go away. This case was linked to MOD-2021-302196 (Patient Link).

Other Meds:

Current Illness:

ID: 1695403
Sex: F
Age:
State: OR

Vax Date: 01/01/2021
Onset Date: 02/19/2021
Rec V Date: 09/13/2021
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: First dose on 1-Jan-2021 and second dose on 19-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Jan-2021 and second dose on 19-Feb-2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Scoliosis, Neurological disorder NOS, Anemia, Dystonia, Allergy to chemicals, Allergy to antibiotic, Drug allergy (Allergy to most oral antifungals, muscle relaxant: Baclofen.) and Drug allergy (Baclofen muscle relaxant). On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 19-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Jan-2021 and second dose on 19-Feb-2021). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Jan-2021 and second dose on 19-Feb-2021) had resolved. Patient stated that she has autoimmune disease but its not official diagnosis. No concomitant medications were reported. Treatment information was not provided. This case was linked to MOD-2021-302183 (Patient Link).

Other Meds:

Current Illness: Allergy to antibiotic; Allergy to chemicals; Anemia; Drug allergy (Baclofen muscle relaxant); Drug allergy (Allergy to most oral antifungals, muscle relaxant: Baclofen.); Dystonia; Neurological disorder NOS; Scoliosis

ID: 1695404
Sex: M
Age:
State: WA

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/13/2021
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: soreness in joints; severely sick; could not move and it took 2 days to get out of her bed; very weird, different and severe than normal flu symptoms; Chills; Fever with 100.9F; soreness in whole body- including joints, muscle.; weird headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severely sick), DYSKINESIA (could not move and it took 2 days to get out of her bed), INFLUENZA LIKE ILLNESS (very weird, different and severe than normal flu symptoms), CHILLS (Chills) and PYREXIA (Fever with 100.9F) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced ILLNESS (severely sick), DYSKINESIA (could not move and it took 2 days to get out of her bed), INFLUENZA LIKE ILLNESS (very weird, different and severe than normal flu symptoms), CHILLS (Chills), PYREXIA (Fever with 100.9F), MYALGIA (soreness in whole body- including joints, muscle.) and HEADACHE (weird headache). On an unknown date, the patient experienced ARTHRALGIA (soreness in joints). At the time of the report, ILLNESS (severely sick), DYSKINESIA (could not move and it took 2 days to get out of her bed), INFLUENZA LIKE ILLNESS (very weird, different and severe than normal flu symptoms), CHILLS (Chills), PYREXIA (Fever with 100.9F), MYALGIA (soreness in whole body- including joints, muscle.), HEADACHE (weird headache) and ARTHRALGIA (soreness in joints) was resolving. The patient was feeling better on 29-Aug-2021. No Concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-302184 (Patient Link).

Other Meds:

Current Illness:

ID: 1695405
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/13/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was provided. No Treatment medications was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695406
Sex: F
Age: 61
State: GA

Vax Date: 08/29/2021
Onset Date: 08/30/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: lower back aches that ache more than the rest of their body; Has had two episodes of loose bright orange stools; two episodes of loose bright orange stools; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 29-Aug-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported

Other Meds:

Current Illness:

ID: 1695407
Sex: U
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/13/2021
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: had discomfort in his in his left arm; discomfort in left arm spread to chest from arm; 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 DISCOMFORT (had discomfort in his in his left arm) and CHEST DISCOMFORT (discomfort in left arm spread to chest from arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (had discomfort in his in his left arm) and CHEST DISCOMFORT (discomfort in left arm spread to chest from arm). At the time of the report, DISCOMFORT (had discomfort in his in his left arm) and CHEST DISCOMFORT (discomfort in left arm spread to chest from arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter. No lab data provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695408
Sex: M
Age: 74
State: FL

Vax Date: 01/05/2021
Onset Date: 02/02/2021
Rec V Date: 09/13/2021
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: Couldn't eat anything; Dry heaves and gagging; pretty weak; Fever; Wicked, bad headache; Sore arm/pain in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak) and PYREXIA (Fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood cholesterol abnormal, Acid reflux (oesophageal) and Blood pressure abnormal. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal, TELMISARTAN for Blood pressure abnormal. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm/pain in arm). On an unknown date, the patient experienced FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-302252.

Other Meds: REPATHA; OMEPRAZOLE; TELMISARTAN

Current Illness: Acid reflux (oesophageal); Blood cholesterol abnormal; Blood pressure abnormal

ID: 1695409
Sex: M
Age: 32
State:

Vax Date: 08/23/2021
Onset Date: 08/28/2021
Rec V Date: 09/13/2021
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: Sore throat; Congestion; Chills; Fevers; Lost my taste and smell; Lost my taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), AGEUSIA (Lost my taste and smell), ANOSMIA (Lost my taste and smell) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced AGEUSIA (Lost my taste and smell). 28-Aug-2021, the patient experienced ANOSMIA (Lost my taste and smell). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers) outcome was unknown and AGEUSIA (Lost my taste and smell) and ANOSMIA (Lost my taste and smell) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. Patient has adipose disease.

Other Meds:

Current Illness:

ID: 1695410
Sex: F
Age: 77
State: GA

Vax Date: 01/27/2021
Onset Date: 03/01/2021
Rec V Date: 09/13/2021
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: It was awful in the beginning; her face swelled up,Cheek swelling; her ears swelled up; her nose swelled up; a rash,her chest had the rash,her arms had the rash; hives; it's burning and itching; it's burning and itching; her hand feels the heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and FEELING ABNORMAL (It was awful in the beginning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included APIXABAN (ELIQUIS) for Blood pressure, URSODIOL for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and RASH (a rash,her chest had the rash,her arms had the rash). On an unknown date, the patient experienced FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up) and SWELLING (her nose swelled up). The patient was treated with PREDNISONE at an unspecified dose and frequency; MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency; DOXEPIN at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 180 mg. At the time of the report, URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat), FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up), SWELLING (her nose swelled up) and RASH (a rash,her chest had the rash,her arms had the rash) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications Steroid shot and Pepcid were reported. Patient visited primary care,dermatologist, allergist, all of them gave her different medications.

Other Meds: ELIQUIS; URSODIOL

Current Illness: Blood pressure abnormal

ID: 1695411
Sex: F
Age: 44
State: CA

Vax Date: 06/07/2021
Onset Date: 06/11/2021
Rec V Date: 09/13/2021
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: 1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination; fatigue; shortness of breath / hard to breath; felt dizzy; had a feeling of heaviness; weakness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder. On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination). At the time of the report, FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Patient reported that she went to see a neurologist, but a diagnosis has not been determined.

Other Meds:

Current Illness:

ID: 1695412
Sex: F
Age: 68
State: NH

Vax Date: 01/15/2021
Onset Date: 02/12/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Name: Holter monitor; Result Unstructured Data: 15%PVCs; Test Name: Holter monitor; Result Unstructured Data: 21%PVCs; Test Date: 20210803; Test Name: MRI heart; Result Unstructured Data: Late gadolinium enhancement abnormal

Allergies:

Symptom List: Tremor

Symptoms: Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%; Extreme fatigue after 2nd dose , I slept for 20 hours; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%) and FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013220A) for COVID-19 vaccination. Concomitant products included LISINOPRIL for Blood pressure high, LEVOTHYROXINE for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours). On 11-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%). The patient was treated with METOPROLOL for Adverse event, at a dose of 1 dosage form. At the time of the report, VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%) and FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Magnetic resonance imaging heart: abnormal (abnormal) Late gadolinium enhancement abnormal. On an unknown date, Electrocardiogram ambulatory: 15 % (abnormal) 15%PVCs and 21% (abnormal) 21%PVCs. The patient reported that blood pressure has been elevated probably due to stress. On 02-Dec-2020, while blood donation patient did not have antibodies and hence declined every infection. The patient reported that on 11-Mar-2021 blood donation was denied due to PVCs which were asymptomatic to the patient and PVCs every 3rd heartbeat. The patient was informed to obtain timeline symptoms including cardiac laboratory values.

Other Meds: LEVOTHYROXINE; LISINOPRIL

Current Illness:

ID: 1695413
Sex: F
Age: 57
State: NC

Vax Date: 03/03/2021
Onset Date: 04/01/2021
Rec V Date: 09/13/2021
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: flu-like symptoms; A little achy; A little sore throat; Tired; Constant ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat), TINNITUS (Constant ringing in both ears) and FATIGUE (Tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 024A21A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat) and FATIGUE (Tired). In April 2021, the patient experienced TINNITUS (Constant ringing in both ears). The patient was treated with PARACETAMOL (TYLENOL) for Flu-like symptoms, at an unspecified dose and frequency. On 02-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat) and FATIGUE (Tired) had resolved. At the time of the report, TINNITUS (Constant ringing in both ears) had not resolved. Patient reported that she went to the doctor but they did not say anything, now she took an appointment to look more into this problem.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1695414
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: extended second Moderna dose up to 90 days; efficacy is greater; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reportedly, Caller had declined consent to document demographic details of the call. Caller had stated that some people had extended their second Moderna COVID-19 dose up to 90 days. He had read that extending the second dose after the first dose for 2 to 3 months had shown greater.No additional detail provided. Consent not given for Safety follow-up. Treatment product information was not provided. Concomitant product use was not provided.

Other Meds:

Current Illness:

ID: 1695415
Sex: F
Age: 27
State: TX

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Name: Covid-19 test; Test Result: Positive ; Result Unstructured Data: positive with coronavirus 10 days after 1st dose

Allergies:

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

Symptoms: Positive with coronavirus 10 days after 1st dose; It's been 36 days and did not receive 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive with coronavirus 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive with coronavirus 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine). At the time of the report, COVID-19 (Positive with coronavirus 10 days after 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive with coronavirus 10 days after 1st dose. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not reported. Treatment medication were not reported.

Other Meds:

Current Illness:

ID: 1695416
Sex: F
Age:
State: FL

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 09/13/2021
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: achiness; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The patient's past medical history included Hip replacement on 28-Jul-2021. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness) and PYREXIA (fever). At the time of the report, PAIN (achiness) and PYREXIA (fever) outcome was unknown. Patient got a Hip Replacement surgery done on 28th july , she was in the hospital for a week and was taking antibiotics for almost a month , she wants to know when can she take her 3rd dose vaccine and if it will affect her surgery site Concomitant medication was not provided treatment information was not provided

Other Meds:

Current Illness:

ID: 1695417
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: his wife had the same reactions also/worse reaction than the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose). At the time of the report, VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose) outcome was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD21-137290, MOD21-137319 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: MOD21-137290:Same reporter MOD21-137319:Same reporter

Other Meds:

Current Illness:

ID: 1695418
Sex: F
Age:
State: TX

Vax Date: 03/14/2021
Onset Date:
Rec V Date: 09/13/2021
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: Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge; not walking much; over time it has gotten hard and it feels like a big rock; She is in so much pain that she can't sleep at night or put any weight on her left hand; She is in so much pain that she can't sleep at night or put any weight on her left hand; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge), GAIT DISTURBANCE (not walking much), INDURATION (over time it has gotten hard and it feels like a big rock), PAIN IN EXTREMITY (She is in so much pain that she can't sleep at night or put any weight on her left hand) and INSOMNIA (She is in so much pain that she can't sleep at night or put any weight on her left hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 PERIPHERAL SWELLING (Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge), GAIT DISTURBANCE (not walking much), INDURATION (over time it has gotten hard and it feels like a big rock), PAIN IN EXTREMITY (She is in so much pain that she can't sleep at night or put any weight on her left hand) and INSOMNIA (She is in so much pain that she can't sleep at night or put any weight on her left hand). At the time of the report, PERIPHERAL SWELLING (Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge), GAIT DISTURBANCE (not walking much), INDURATION (over time it has gotten hard and it feels like a big rock), PAIN IN EXTREMITY (She is in so much pain that she can't sleep at night or put any weight on her left hand) and INSOMNIA (She is in so much pain that she can't sleep at night or put any weight on her left hand) outcome was unknown. No Concomitant medications were provided. No Treatment medications were provided.

Other Meds:

Current Illness:

ID: 1695419
Sex: U
Age:
State: CA

Vax Date: 01/23/2021
Onset Date: 02/26/2021
Rec V Date: 09/13/2021
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: COVID arm upper arm; very large rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm upper arm) and RASH (very large rash) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced RASH (very large rash). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm upper arm). At the time of the report, VACCINATION SITE REACTION (COVID arm upper arm) and RASH (very large rash) outcome was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1695420
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: inside of my mouth irritated; inside of my mouth so red; lips inside mouth red; lips inside mouth irratated; lips inside mouth dry; inside of my mouth so dry; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated) and LIP DRY (lips inside mouth dry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated), LIP DRY (lips inside mouth dry) and DRY MOUTH (inside of my mouth so dry). At the time of the report, STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated), LIP DRY (lips inside mouth dry) and DRY MOUTH (inside of my mouth so dry) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695421
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy spells). At the time of the report, DIZZINESS (Dizzy spells) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. The patient enquired if having dizzy spells was a common side effect.

Other Meds:

Current Illness:

ID: 1695422
Sex: F
Age: 54
State: NY

Vax Date: 04/07/2021
Onset Date: 05/01/2021
Rec V Date: 09/13/2021
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: menstruation; leg pain,foot pain; She had not menstruated in over 3 years before that; chills; vomiting; headache; fever; More than 36 days since caller got the first dose and still has not the second; missed dose; pain on her nipples; pain on her breasts; tenderness on her breasts; menstrual cramps; urinary track infection; hemorroids; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids) and NIPPLE PAIN (pain on her nipples) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Amenorrhea (amenorrhea.). On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced URINARY TRACT INFECTION (urinary track infection) and HAEMORRHOIDS (hemorroids). In June 2021, the patient experienced NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts) and DYSMENORRHOEA (menstrual cramps). On an unknown date, the patient experienced MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids), NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts), DYSMENORRHOEA (menstrual cramps), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was reported. Other treatment Medication provided was antibiotics for UTI and over the counter Cream for Hemorrhoids. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new event.

Other Meds:

Current Illness:

ID: 1695423
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: foot numb from shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (foot numb from shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (foot numb from shot). At the time of the report, HYPOAESTHESIA (foot numb from shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information were provided. No treatment information were provided.

Other Meds:

Current Illness:

ID: 1695424
Sex: U
Age:
State: RI

Vax Date: 08/30/2021
Onset Date:
Rec V Date: 09/13/2021
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: Received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1695425
Sex: M
Age: 68
State: OH

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included Heart attack (Patient had 3 heart attacks) and Stroke. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No Treatment information was provided. Patient was vegan for 10 yrs now. And use no oils in his diet This case was linked to MOD-2021-302658 (Patient Link).

Other Meds:

Current Illness:

ID: 1695426
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: adverse event; 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 ADVERSE EVENT (adverse event) 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 ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) 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 was provided by the reporter No treatment information was reported.

Other Meds:

Current Illness:

ID: 1695427
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/13/2021
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: Fairly moderate side effects; Malaise; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Fairly moderate side effects), MALAISE (Malaise), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 in December 2020. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Fairly moderate side effects), MALAISE (Malaise), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, VACCINATION COMPLICATION (Fairly moderate side effects), MALAISE (Malaise), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product information was provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695428
Sex: F
Age: 62
State: OH

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm from the injection; My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm from the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm from the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm from the injection) outcome was unknown. Concomitant medication was not reported. Treatment information was not reported. This case was linked to MOD-2021-302673 (Patient Link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am