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: 1640174
Sex: M
Age: 82
State: OH

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 101.4

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: in the evening he was freezing to death; started shaking so hard, almost uncontrollably; Sweating; Had issues after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LISINOPRIL for an unknown indication. On 16-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 FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine). At the time of the report, FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) 101.4. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not reported. Treatment medications was not reported. Patient stated he Had issues after receiving the vaccine This case was linked to MOD-2021-229842 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant Follow-up received on 28-Jul-2021, added Date of Birth, contact information and event

Other Meds: LISINOPRIL

Current Illness:

ID: 1640175
Sex: M
Age: 73
State: WA

Vax Date: 03/20/2021
Onset Date: 04/20/2021
Rec V Date: 08/27/2021
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: Explosive diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhoea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included MAGNESIUM OXIDE, VITAMIN D NOS, LEVOTHYROXINE and ALBUTEROL [SALBUTAMOL] for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced DIARRHOEA (Explosive diarrhoea). At the time of the report, DIARRHOEA (Explosive diarrhoea) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: MAGNESIUM OXIDE; VITAMIN D NOS; LEVOTHYROXINE; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1640176
Sex: F
Age:
State: PA

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 08/27/2021
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: fever; stiff neck; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), the first episode of PYREXIA (fever) and the second episode of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Jun-2021, the patient experienced the first episode of PYREXIA (fever). On 15-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck). On 20-Jun-2021, the patient experienced the second episode of PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Stiff neck, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Fever and Stiff neck, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved and last episode of PYREXIA (fever) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-229873 (Patient Link).

Other Meds:

Current Illness:

ID: 1640177
Sex: F
Age: 51
State: AR

Vax Date: 05/14/2021
Onset Date:
Rec V Date: 08/27/2021
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: hard spot at the injection site; itchy red bumps at the injection site; itchy red bumps at the injection site; itchy red bumps at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia (chronic nerve and muscle pain). Concomitant products included CANNABIDIOL and MARIJUANA for an unknown indication. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site) had resolved. Action taken with mRNA-1273 in response to the events was not applicable Patient stated she was on opiates for 4 years This case was linked to MOD-2021-229938 (Patient Link).

Other Meds: CANNABIDIOL; MARIJUANA

Current Illness: Fibromyalgia (chronic nerve and muscle pain)

ID: 1640178
Sex: F
Age:
State: MT

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 08/27/2021
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: Red rash appeared on that arm; Large red bump under my left eye; Arms are now fully red from elbow to top of hands both arms; Dry skin; Spots on my legs that look like I've been bit; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye), ERYTHEMA (Arms are now fully red from elbow to top of hands both arms), DRY SKIN (Dry skin) and BITE (Spots on my legs that look like I've been bit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN, CARVEDILOL, ESOMEPRAZOLE and HYDROCHLOROTHIAZIDE for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye), ERYTHEMA (Arms are now fully red from elbow to top of hands both arms), DRY SKIN (Dry skin) and BITE (Spots on my legs that look like I've been bit). The patient was treated with MACROGOL, PROPYLENE GLYCOL, SIMETICONE, SORBIC ACID, SORBITOL, WHITE SOFT PARAFFIN (VANICREAM) for Dry skin, at a dose of 1 dosage form; ACRIVASTINE (BENADRYL [ACRIVASTINE]) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and TRIAMCINOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye) and DRY SKIN (Dry skin) had not resolved and ERYTHEMA (Arms are now fully red from elbow to top of hands both arms) and BITE (Spots on my legs that look like I've been bit) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-039266 (Patient Link).

Other Meds: XARELTO; ATORVASTATIN; CARVEDILOL; ESOMEPRAZOLE; HYDROCHLOROTHIAZIDE

Current Illness: Dust allergy; Pollen allergy

ID: 1640179
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Side effect; 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 VACCINATION COMPLICATION (Side effect) 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 (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) 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.

Other Meds:

Current Illness:

ID: 1640180
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: heart palpitations; 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 PALPITATIONS (heart palpitations) 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 PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) 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: 1640181
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: 17 year old received 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose of Moderna COVID-19 vaccine) in a 17-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose of Moderna COVID-19 vaccine) 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 medications were provided.

Other Meds:

Current Illness:

ID: 1640182
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant information was provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1640183
Sex: M
Age: 65
State: MS

Vax Date: 02/27/2021
Onset Date: 03/27/2021
Rec V Date: 08/27/2021
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: light swelling like a bee sting apper on left wrist; itching/pruritus; rash "like a bee sting" of left wrist; This spontaneous case was reported by a patient and describes the occurrence of JOINT SWELLING (light swelling like a bee sting apper on left wrist), PRURITUS (itching/pruritus) and RASH (rash "like a bee sting" of left wrist) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013A214) for COVID-19 vaccination. Concomitant products included MELOXICAM from 02-Jan-2010 to an unknown date and VALSARTAN from 02-Jan-2010 to an unknown date for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash "like a bee sting" of left wrist). On an unknown date, the patient experienced JOINT SWELLING (light swelling like a bee sting apper on left wrist) and PRURITUS (itching/pruritus). At the time of the report, JOINT SWELLING (light swelling like a bee sting apper on left wrist), PRURITUS (itching/pruritus) and RASH (rash "like a bee sting" of left wrist) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant included pain killer was included. GBmetalic hcl for unknown indication on 02-Jan-2010. No treatment information was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received include no new significant information On 27-Jul-2021: Updated race, height, con med added.

Other Meds: MELOXICAM; VALSARTAN

Current Illness:

ID: 1640184
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021 and was forwarded to the company on 21-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not provided. Treatment information not provided. Consent for follow up accepted.

Other Meds:

Current Illness:

ID: 1640185
Sex: U
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: They used this expired vial and administered 4 doses to 4 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They used this expired vial and administered 4 doses to 4 patients) 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) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They used this expired vial and administered 4 doses to 4 patients). For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1640186
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: patient cannot stop vomiting after receiving the second dose on Friday; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (patient cannot stop vomiting after receiving the second dose on Friday) 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 VOMITING (patient cannot stop vomiting after receiving the second dose on Friday). At the time of the report, VOMITING (patient cannot stop vomiting after receiving the second dose on Friday) outcome was unknown. No concomitant medication was reported No treatment medication was reported

Other Meds:

Current Illness:

ID: 1640187
Sex: F
Age: 54
State: CO

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ALS got better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (ALS got better) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. Concurrent medical conditions included ALS. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (ALS got better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (ALS got better) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was taking ALS medications concomitantly. The patient felt that her ALS got better after getting the vaccine. She stated that 3 weeks after her first dose, it was easy for her to get up off the bed, it normally takes her a lot of effort to get up. She was able to stand up on her own. 3 days later, she had more energy to roll over in her bed. It usually takes a lot of effort. No treatment information was provided.

Other Meds:

Current Illness: ALS

ID: 1640188
Sex: F
Age: 35
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210525; Test Name: aPTT; Result Unstructured Data: aPTT 25.4, 25.3; Test Date: 20210525; Test Name: Lupus anticoagulant qual; Test Result: Inconclusive ; Result Unstructured Data: Lupus anticoagulant qual Not detected; Test Date: 20210525; Test Name: Antithrombin III activity %; Test Result: Inconclusive ; Result Unstructured Data: Antithrombin III activity % 124; Test Date: 20210525; Test Name: Factor VII activity clotting %; Test Result: Inconclusive ; Result Unstructured Data: Factor VII activity clotting % 55; Test Date: 20210525; Test Name: Protein C activity %; Result Unstructured Data: Protein S Activity% 146(H); Test Date: 20210525; Test Name: Protein S Activity%; Result Unstructured Data: Protein S Activity% 127(H); Test Date: 20210525; Test Name: PT sec; Test Result: 9.5 s; Result Unstructured Data: PT sec 9.5, 9.5 INR 0.9; Test Date: 20210525; Test Name: Dilute Russell viper venom time sec; Test Result: Inconclusive 26.9 s; Result Unstructured Data: Dilute Russell viper venom time 26.9 sec

Allergies:

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

Symptoms: Soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Concomitant products included LEVONORGESTREL (MIRENA) from 01-Jan-2019 to an unknown date for Birth control. On 06-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021 at 4:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Activated partial thromboplastin time: 25.4, 25.3 Second (Low) aPTT 25.4, 25.3. On 25-May-2021, Antiphospholipid antibodies: not detected (Inconclusive) Lupus anticoagulant qual Not detected. On 25-May-2021, Antithrombin III: 124 (Inconclusive) Antithrombin III activity % 124. On 25-May-2021, Coagulation factor VII level: 55 (Inconclusive) Factor VII activity clotting % 55. On 25-May-2021, Protein C: 146 (High) Protein S Activity% 146(H). On 25-May-2021, Protein S: 127 (High) Protein S Activity% 127(H). On 25-May-2021, Prothrombin time: 9.5 Second (High) PT sec 9.5, 9.5 INR 0.9. On 25-May-2021, Russell's viper venom time: 26.9 Second (Inconclusive) Dilute Russell viper venom time 26.9 sec. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication details provided. This case was linked to MOD-2021-168832 (Patient Link).

Other Meds: MIRENA

Current Illness:

ID: 1640189
Sex: F
Age: 77
State: GA

Vax Date: 01/16/2021
Onset Date: 02/10/2021
Rec V Date: 08/27/2021
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: Tired/Fatigue; Lack of interest in doing anything (Used to read books); Pain Injection Site came back again and the pain spread to other body parts after second Shot; Aches and Pain on Both Upper Arms after second Shot; Pain on the Injection site after second Shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot), PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot), FATIGUE (Tired/Fatigue), VACCINATION SITE PAIN (Pain on the Injection site after second Shot) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus non-insulin-dependent and Blood pressure high. Concomitant products included METOPROLOL and ENALAPRIL for Blood pressure, METFORMIN for Diabetes mellitus, LOVASTATIN and INDAPAMIDE for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the Injection site after second Shot). On 20-Mar-2021, the patient experienced PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot) and PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot). On an unknown date, the patient experienced FATIGUE (Tired/Fatigue) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Pain, at an unspecified dose and frequency and MELOXICAM for Pain, at an unspecified dose and frequency. On 11-Feb-2021, VACCINATION SITE PAIN (Pain on the Injection site after second Shot) had resolved. At the time of the report, PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot), PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot), FATIGUE (Tired/Fatigue) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had been having aches and pain on both upper arms for 3 months.

Other Meds: LOVASTATIN; METOPROLOL; ENALAPRIL; INDAPAMIDE; METFORMIN

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

ID: 1640190
Sex: U
Age:
State:

Vax Date: 06/20/2021
Onset Date: 06/20/2021
Rec V Date: 08/27/2021
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: Headache; Chills; Sweating; Nausea; Feel awful; Woke up in middle of night; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and FEELING ABNORMAL (Feel awful) 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 20-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night). At the time of the report, HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information provided. No treatment information provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1640191
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1640192
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: loss of hair alot; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (loss of hair alot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (loss of hair alot). At the time of the report, ALOPECIA (loss of hair alot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment medications information was not provided.

Other Meds:

Current Illness:

ID: 1640193
Sex: F
Age: 27
State: CA

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 08/27/2021
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: spasming pain; Couldn't lift her head; Neck spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Neck spasms), HEAD DISCOMFORT (Couldn't lift her head) and PAIN (spasming pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced MUSCLE SPASMS (Neck spasms). On 19-May-2021, the patient experienced HEAD DISCOMFORT (Couldn't lift her head). On an unknown date, the patient experienced PAIN (spasming pain). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency. On 21-May-2021, MUSCLE SPASMS (Neck spasms), HEAD DISCOMFORT (Couldn't lift her head) and PAIN (spasming pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment narcotic (unspecified) for pain medicine.

Other Meds:

Current Illness:

ID: 1640194
Sex: M
Age: 46
State: WA

Vax Date: 04/23/2021
Onset Date: 04/28/2021
Rec V Date: 08/27/2021
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: Test Date: 20210503; Test Name: Joint aspiration; Test Result: Inconclusive ; Result Unstructured Data: 55 milliliters of fluid was removed from the patients right knee.; Test Date: 20210507; Test Name: Joint aspiration; Test Result: Inconclusive ; Result Unstructured Data: 35 milliliters were removed from the right knee.; Test Name: Blood test; Result Unstructured Data: unknown; Test Name: MRI; Result Unstructured Data: No structural damage

Allergies:

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

Symptoms: Ability to walk limited; Cant sleep; Night sweat; Right knee swelled\right knee swelled to the size of a melon; Pain high; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), PAIN (Pain high), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No medical history was provided. Concomitant products included INSULIN GLARGINE (BASAGLAR) from 11-Jan-2018 to an unknown date, METFORMIN from 11-Jan-2018 to an unknown date, LISINOPRIL from 11-Jan-2018 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) from 11-Jan-2018 to an unknown date for an unknown indication. On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN (Pain high). On 17-May-2021, the patient experienced JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon). On 18-May-2021, the patient experienced NIGHT SWEATS (Night sweat). On an unknown date, the patient experienced GAIT DISTURBANCE (Ability to walk limited) and INSOMNIA (Cant sleep). The patient was treated with CORTISONE at a dose of 1 dosage form, Right knee; PREDNISONE at a dose of UNK dosage form; METHOTREXATE at a dose of UNK dosage form and Physical therapy for Joint swelling. At the time of the report, JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) outcome was unknown and PAIN (Pain high) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Aspiration joint: abnormal (Inconclusive) 55 milliliters of fluid was removed from the patients right knee.. On 07-May-2021, Aspiration joint: abnormal (Inconclusive) 35 milliliters were removed from the right knee.. On an unknown date, Blood test: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown (normal) No structural damage. This case was linked to MOD-2021-229819 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Initial Additional Document received and contains significant information. updated with patient demographic information, concomitant drug information, non serious events and its outcome.

Other Meds: BASAGLAR; METFORMIN; LISINOPRIL; JARDIANCE

Current Illness:

ID: 1640195
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Hot to touch at injection site; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1640196
Sex: F
Age: 64
State: NV

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 08/27/2021
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: body aches; very tired; pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back). At the time of the report, MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back) 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 considered BACK PAIN (pain in the back) to be possibly related. No further causality assessments were provided for MYALGIA (body aches) and FATIGUE (very tired).

Other Meds: LISINOPRIL; SIMVASTATIN

Current Illness:

ID: 1640197
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Feeling groggy; Really tired; Achy; 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 SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy) 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 SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy). At the time of the report, SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1640198
Sex: F
Age: 51
State: AR

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 08/27/2021
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: started her period again, but it was bright pink and red; intense abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (intense abdominal cramping) and MENSTRUAL DISORDER (started her period again, but it was bright pink and red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The patient's past medical history included Opiates (On opiates for 14 years). Concomitant products included CANNABIDIOL and MARIJUANA for an unknown indication. On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced ABDOMINAL PAIN (intense abdominal cramping). On 12-Jun-2021, the patient experienced MENSTRUAL DISORDER (started her period again, but it was bright pink and red). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 11-Jun-2021, ABDOMINAL PAIN (intense abdominal cramping) had resolved. At the time of the report, MENSTRUAL DISORDER (started her period again, but it was bright pink and red) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-229893 (Patient Link).

Other Meds: CANNABIDIOL; MARIJUANA

Current Illness:

ID: 1640199
Sex: U
Age:
State:

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 08/27/2021
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: The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one; My armpit were sore/The side I had injections on is swollen and sore; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one) and MYALGIA (My armpit were sore/The side I had injections on is swollen and sore) 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 01-Jun-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 SWELLING (The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one) and MYALGIA (My armpit were sore/The side I had injections on is swollen and sore). At the time of the report, SWELLING (The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one) and MYALGIA (My armpit were sore/The side I had injections on is swollen and sore) outcome was unknown. Concomitant medication information was not reported by the reporter. Treatment information was not provided. The action taken with mRNA-1273 with the events was considered as not applicable. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1640200
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: I have some kind efdecrs and my mother too; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have some kind efdecrs and my mother too) 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 (I have some kind efdecrs and my mother too). At the time of the report, VACCINATION COMPLICATION (I have some kind efdecrs and my mother too) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment and concomitant details were provided. This case was linked to MOD-2021-230201 (Patient Link).

Other Meds:

Current Illness:

ID: 1640201
Sex: M
Age: 66
State: OH

Vax Date: 02/15/2021
Onset Date: 02/25/2021
Rec V Date: 08/27/2021
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: He did not get a 2nd dose of vaccine; Burning symptoms; Light rash; Head, face, back, hands and feet tingling and stinging; Head, face, back, hands and feet tingling and stinging; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine), PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging), BURNING SENSATION (Burning symptoms) and RASH (Light rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Bipolar disorder and Hypertension. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging) and RASH (Light rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine) and BURNING SENSATION (Burning symptoms). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine) had resolved and PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging), BURNING SENSATION (Burning symptoms) and RASH (Light rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the concomitant medications included: Bipolar and blood pressure medications I t was reported that the treatment information included Antihistamine and topical cream for burning symptoms, tingling and stinging. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Additional Information received included no new information On 23-Jul-2021: Additional Information received included no new information On 27-Jul-2021: Additional Information received included patient's age.

Other Meds:

Current Illness: Bipolar disorder; Hypertension

ID: 1640202
Sex: F
Age: 74
State: CA

Vax Date: 06/08/2021
Onset Date: 06/17/2021
Rec V Date: 08/27/2021
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: injection site was red and itchy; injection site was red and itchy/she still has redness in the injection site; headache/she still has some headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site was red and itchy), VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Blood pressure fluctuation. Concomitant products included DICLOFENAC and MISOPROSTOL for an unknown indication. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was red and itchy), VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 20-Jun-2021, VACCINATION SITE PRURITUS (injection site was red and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included diabetes medication and blood pressure medication(unspecified). Treatment included ice on the injection site. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 and contain significant information. The events vaccination site erythema and headache became serious with criteria other medically important condition. Added vaccine batch number. Changed the outcome of the event vaccination site erythema from recovered to not recovered. Changed the outcome of the event headache from unknown to not recovered.; 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: DICLOFENAC; MISOPROSTOL

Current Illness: Blood pressure fluctuation; Diabetes

ID: 1640203
Sex: F
Age: 64
State: NV

Vax Date: 04/22/2021
Onset Date: 06/17/2021
Rec V Date: 08/27/2021
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: fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints; wrist hurt; Lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints), ARTHRALGIA (wrist hurt) and BACK PAIN (Lower back pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B121A and 019B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced BACK PAIN (Lower back pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints) and ARTHRALGIA (wrist hurt). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints), ARTHRALGIA (wrist hurt) and BACK PAIN (Lower back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: LISINOPRIL; SIMVASTATIN

Current Illness:

ID: 1640204
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Does your vaccine cause tinnitus?; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Does your vaccine cause tinnitus?) 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 TINNITUS (Does your vaccine cause tinnitus?). At the time of the report, TINNITUS (Does your vaccine cause tinnitus?) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1640205
Sex: M
Age: 66
State: TX

Vax Date: 06/19/2021
Onset Date: 06/19/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Normal; Test Name: Heart rate; Result Unstructured Data: Normal

Allergies:

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

Symptoms: Sweety hand; Having trouble sleeping waking up every 3 hours; Sore throat; Cannot taste his food; Stomach hurt; Pain in the lower left chest; Pain that come and goes in the upper right side of the jaw; Dizziness; Not feeling well; Weakness; Extremely strong headache; Very very nauseous; General fatigue\ Tiredness; Muscle pain; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food) and ABDOMINAL PAIN UPPER (Stomach hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Past medical history includes in 2011 Patient had a minor brain stroke

Other Meds: BABY ASPIRIN

Current Illness:

ID: 1640206
Sex: F
Age: 31
State: OK

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 08/27/2021
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: Pregnant woman received her 1st dose of vaccine; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. Concurrent medical conditions included Factor V Leiden mutation (Factor 5 Leiden Disorder (genetic Disorder)). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Jan-2021 and the estimated date of delivery was 22-Oct-2021. On 17-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-second week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included Synthroid ,Prenatal Vitamins. No treatment information was reported. The reporter reported that the patient was pregnant and received her 1st dose of vaccine. Pregnancy was of 2nd trimester Last date of Menstruation was around 15-JAN-2021 (patient wasn't sure) Date of Conception reported as 25-JAN-2021.

Other Meds: SYNTHROID; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness: Factor V Leiden mutation (Factor 5 Leiden Disorder (genetic Disorder))

ID: 1640207
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: vomiting after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting after 2nd dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting after 2nd dose). At the time of the report, VOMITING (vomiting after 2nd dose) outcome was unknown. Not Provided No concomitant medication was provided by the reporter. No treatment information was given by the reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1640208
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Arm is very swollen; Hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is very swollen) and MYALGIA (Hurts a lot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is very swollen) and MYALGIA (Hurts a lot). At the time of the report, PERIPHERAL SWELLING (Arm is very swollen) and MYALGIA (Hurts a lot) outcome was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided. Action take with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1640209
Sex: F
Age: 27
State: NJ

Vax Date: 05/15/2021
Onset Date: 06/12/2021
Rec V Date: 08/27/2021
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: swelling at the injection site; itch at the injection site; dark spot at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site) in a t-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination. No Medical History information was reported. On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced HEADACHE (headache). On 14-Jun-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site). At the time of the report, HEADACHE (headache), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site) outcome was unknown. No concomitant medications details provided. No treatment details provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) with response to events was not applicable.

Other Meds:

Current Illness:

ID: 1640210
Sex: F
Age: 57
State: SC

Vax Date: 03/11/2021
Onset Date: 04/10/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Felt like garbage /like i got ran over by a truck; Got sick; Woke up drenched in sweat; Chills; Violent headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like garbage /like i got ran over by a truck), ILLNESS (Got sick), HYPERHIDROSIS (Woke up drenched in sweat), CHILLS (Chills) and HEADACHE (Violent headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027A21A) for COVID-19 vaccination. Concomitant products included AMLODIPINE for Hypertension, DUPILUMAB (DUPIXENT) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like garbage /like i got ran over by a truck), ILLNESS (Got sick), HYPERHIDROSIS (Woke up drenched in sweat), CHILLS (Chills) and HEADACHE (Violent headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Apr-2021, FEELING ABNORMAL (Felt like garbage /like i got ran over by a truck), ILLNESS (Got sick), HYPERHIDROSIS (Woke up drenched in sweat), CHILLS (Chills) and HEADACHE (Violent headache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient messed with doses of Dupixent and skipped a couple doses before and after the vaccine was received.

Other Meds: DUPIXENT; AMLODIPINE

Current Illness:

ID: 1640211
Sex: F
Age: 68
State: NY

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 08/27/2021
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: Chills; Fever; Intense muscle paid the next day/ ongoing muscle aches and pains; felt terrible/ difficulty focusing and foggy; tiredness/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 036B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue) outcome was unknown. The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter.

Other Meds:

Current Illness:

ID: 1640212
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/02/2021
Rec V Date: 08/27/2021
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: low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (low grade fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medication history was provided. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1640213
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/27/2021
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: tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown. Upon internal review on 04-Aug-2021, the age was corrected to 65 years.

Other Meds:

Current Illness:

ID: 1640214
Sex: U
Age:
State:

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 08/27/2021
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: First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-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 PRODUCT DOSE OMISSION ISSUE (First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1640215
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 01/18/2021
Rec V Date: 08/27/2021
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: Dizziness; Injection site pain; Got rash on left arm; Skin near the injection site is raised; Diarrhea; Couldn't catch balance; Had spinning sensation; Could not sleep well; Arm was hot; Sinus Problems; Arm was sore - sore; Kind of tight at injection site; Extremely Fatigued; Stabbing pain in left strap/shoulder, back side of it; General feeling of not being well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm was hot), SINUS DISORDER (Sinus Problems), BALANCE DISORDER (Couldn't catch balance), VERTIGO (Had spinning sensation) and INSOMNIA (Could not sleep well) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (General feeling of not being well). On 17-Jun-2021, the patient experienced ARTHRALGIA (Stabbing pain in left strap/shoulder, back side of it). On 18-Jun-2021, the patient experienced FEELING HOT (Arm was hot) and SINUS DISORDER (Sinus Problems). 18-Jun-2021, the patient experienced INSOMNIA (Could not sleep well), MYALGIA (Arm was sore - sore), VACCINATION SITE INDURATION (Kind of tight at injection site) and FATIGUE (Extremely Fatigued). On 19-Jun-2021, the patient experienced BALANCE DISORDER (Couldn't catch balance) and VERTIGO (Had spinning sensation). 19-Jun-2021, the patient experienced DIARRHOEA (Diarrhea). On 20-Jun-2021, the patient experienced RASH (Got rash on left arm) and VACCINATION SITE SWELLING (Skin near the injection site is raised). On an unknown date, the patient experienced DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with ACETAMINOPHEN on 18-Jun-2021 at a dose of 1000 milligram; IBUPROFEN (IBUPRO [IBUPROFEN]) on 18-Jun-2021 at a dose of 600 milligram; PHENYLEPHRINE HCL from 18-Jun-2021 to 19-Jun-2021 at a dose of 10 milligram and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 20-Jun-2021 for Rash, at a dose of UNK dosage form. On 17-Jun-2021, ARTHRALGIA (Stabbing pain in left strap/shoulder, back side of it) had resolved. On 19-Jun-2021, FEELING HOT (Arm was hot), BALANCE DISORDER (Couldn't catch balance), VERTIGO (Had spinning sensation), INSOMNIA (Could not sleep well), DIZZINESS (Dizziness), MYALGIA (Arm was sore - sore), MALAISE (General feeling of not being well), VACCINATION SITE INDURATION (Kind of tight at injection site), FATIGUE (Extremely Fatigued) and VACCINATION SITE PAIN (Injection site pain) had resolved. At the time of the report, SINUS DISORDER (Sinus Problems) was resolving and DIARRHOEA (Diarrhea), RASH (Got rash on left arm) and VACCINATION SITE SWELLING (Skin near the injection site is raised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications provided by the reporter were nasal decongestant. Action taken with mRNA-1273 in response to the events were not Applicable. This case was linked to MOD-2021-163904 (Patient Link).

Other Meds:

Current Illness:

ID: 1640216
Sex: U
Age:
State:

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 08/27/2021
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: Effects; I had the injection (2nd dose - first was a Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Effects) and INTERCHANGE OF VACCINE PRODUCTS (I had the injection (2nd dose - first was a Pfizer) 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 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (I had the injection (2nd dose - first was a Pfizer). On an unknown date, the patient experienced VACCINATION COMPLICATION (Effects). At the time of the report, VACCINATION COMPLICATION (Effects) and INTERCHANGE OF VACCINE PRODUCTS (I had the injection (2nd dose - first was a Pfizer) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. On 01 Apr 2021, the patient received the first dose of the Pfizer vaccine. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1640217
Sex: F
Age: 18
State: NC

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 08/27/2021
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: noticeable bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (noticeable bruise at the injection site) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. No Medical history was provided by the Reporter. Concomitant products included LORATADINE for an unknown indication. On 19-May-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 CONTUSION (noticeable bruise at the injection site). At the time of the report, CONTUSION (noticeable bruise at the injection site) 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 treatment medication was reported. This case was linked to MOD-2021-229987 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-JUN-2021 and Updated secondary Reporter details and patient initials and updated suspect vaccine Lot number and Updated new Concomitant medication details.

Other Meds: LORATADINE

Current Illness:

ID: 1640218
Sex: U
Age:
State: AL

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/27/2021
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: More than 36 days after the first dose without receiving the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medications were provided. No concomitant medication information was provided.

Other Meds:

Current Illness:

ID: 1640219
Sex: F
Age: 39
State: CA

Vax Date: 05/03/2021
Onset Date: 06/17/2021
Rec V Date: 08/27/2021
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: 2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient; it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 042B21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured). On 17-Jun-2021, EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication details was reported. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 Contains No significant information

Other Meds: METFORMIN

Current Illness: Diabetes

ID: 1640220
Sex: F
Age:
State: CA

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/27/2021
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: rash all over; red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over) and RASH ERYTHEMATOUS (red rash) 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 21-Jun-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 21-Jun-2021, the patient experienced RASH (rash all over) and RASH ERYTHEMATOUS (red rash). At the time of the report, RASH (rash all over) and RASH ERYTHEMATOUS (red rash) outcome was unknown. No concomitant medications was reported by the reporter No treatment medications was provided by the reporter.

Other Meds:

Current Illness:

ID: 1640221
Sex: F
Age:
State: AZ

Vax Date: 02/18/2021
Onset Date: 02/21/2021
Rec V Date: 08/27/2021
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: redness at injection site,about 3 inches around, and not as severe in intensity.; swelling at injection site,about 3 inches around, and not as severe in intensity.; Itching at injection site,about 3 inches around, and not as severe in intensity.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication. On 18-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.). At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.) outcome was unknown. Not Provided No treatment medications were reported. Patient height was reported as 5'7 and weight was reported as 150. This case was linked to MOD-2021-027223 (Patient Link).

Other Meds: VESICARE

Current Illness: Penicillin allergy

ID: 1640222
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Great pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Great pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Great pain). At the time of the report, MYALGIA (Great pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information provided. No treatment information given.

Other Meds:

Current Illness:

ID: 1640223
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: How long side effects last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long side effects last) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long side effects last). At the time of the report, VACCINATION COMPLICATION (How long side effects last) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products reported. No treatment products reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am