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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1639523
Sex: M
Age:
State: CT

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

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

Lab Data: Test Date: 2021; Test Name: BMI; Result Unstructured Data: 20.85; Test Date: 2021; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: positive for SARS-CoV-2 infection; lack of drug effect; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (positive for SARS-CoV-2 infection) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension and Kidney transplant. Concomitant products included TRIAMCINOLONE, MYCOPHENOLATE MOFETIL (MMF) and PREDNISONE for an unknown indication. 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (positive for SARS-CoV-2 infection) (seriousness criteria hospitalization and medically significant) and DRUG INEFFECTIVE (lack of drug effect). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to COVID-19. The patient was treated with DEXAMETHASONE for Adverse event, at a dose of 1 dosage form and REMDESIVIR for Adverse event, at a dose of 1 dosage form. At the time of the report, COVID-19 (positive for SARS-CoV-2 infection) was resolving and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Metabolic function test: 20.85 (normal) 20.85. In 2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (positive for SARS-CoV-2 infection) to be possibly related. No further causality assessment was provided for DRUG INEFFECTIVE (lack of drug effect). Part of a retrospective, observational study of SOTR patients who received SARS-CoV-2 vaccine that was conducted at a Hospital by chart review. Severity of COVID-19 classified by authors as "severe." Company comment: This is a case of lack of efficacy of the product in an immunosuppressed transplant patient. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Report contains no significant information.; Sender's Comments: This is a case of lack of efficacy of the product in an immunosuppressed transplant patient. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.

Other Meds: TRIAMCINOLONE; MMF; PREDNISONE

Current Illness:

ID: 1639524
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
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: Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 70-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt tired). At the time of the report, FATIGUE (Felt tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1639525
Sex: F
Age:
State: MS

Vax Date: 03/15/2021
Onset Date: 06/09/2021
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: Test Date: 20210324; Test Name: Covid swab test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: Different vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Different vaccine administered) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. Concurrent medical conditions included Congestive heart failure, BP raised, Diabetes, Allergy and Stomach ache. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 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 09-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Different vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at a dose of 1 dosage form. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Different vaccine administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Cardiovascular examination: unknown (Inconclusive) unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication was reported. No treatment information was provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: event outcome updated.

Other Meds:

Current Illness: Allergy; BP raised; Congestive heart failure; Diabetes; Stomach ache

ID: 1639526
Sex: M
Age:
State: TX

Vax Date: 02/12/2021
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: Specs or floaters in eyes; Hazed over eye like cateract is returning; flash of light in left eye when looks to right/ flash of light in right eye when looks to left; Vision impaired; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cataract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left) and VISUAL IMPAIRMENT (Vision impaired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination. The patient's past medical history included Cataract (right) (First cataract surgery on right eye) on 10-Dec-2020 and Cataract (left) (Second cataract surgery on left eye) on 05-Jan-2021. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cateract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left ) and VISUAL IMPAIRMENT (Vision impaired). At the time of the report, VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cateract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left ) and VISUAL IMPAIRMENT (Vision impaired) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1639527
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: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: chronic cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (chronic cough) 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, 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 COUGH (chronic cough). At the time of the report, COUGH (chronic cough) outcome was unknown. No relevant concomitant medications were reported. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1639528
Sex: F
Age: 48
State: TX

Vax Date: 04/21/2021
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: Patient stated she had red liquid come out with her bowel movement; Caller does not want to receive the second dose; tired blood" or "not enough iron in your blood; This spontaneous case was reported by a consumer and describes the occurrence of ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The patient's past medical history included Immune system disorder (Weak immune system and frail) and Rash (Rash allergy). Concurrent medical conditions included Leukemia. On 21-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 ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood). At the time of the report, ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021 contains no new information On 20-Jun-2021: Patient contact information updated and event added

Other Meds:

Current Illness: Leukemia

ID: 1639529
Sex: M
Age: 51
State: IL

Vax Date: 06/09/2021
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: Tiredness; This spontaneous case was reported by a study coodinator and describes the occurrence of FATIGUE (Tiredness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown. Concomitant medication was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1639530
Sex: F
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: Pharyngeal swelling

Symptoms: Estradiol Transdermal system causing burning; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Estradiol Transdermal system causing burning) 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 THERMAL BURN (Estradiol Transdermal system causing burning). At the time of the report, THERMAL BURN (Estradiol Transdermal system causing burning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to AE-2021-8730 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: AE-2021-8730:

Other Meds:

Current Illness:

ID: 1639531
Sex: F
Age: 57
State: CA

Vax Date: 02/01/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Did not have antibodies; This spontaneous case was reported by an other and describes the occurrence of ANTIBODY TEST NEGATIVE (Did not have antibodies) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Did not have antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (Did not have antibodies) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. No treatment information provided.

Other Meds:

Current Illness: Multiple sclerosis

ID: 1639532
Sex: F
Age:
State: NC

Vax Date: 05/17/2021
Onset Date: 05/18/2021
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: She cant move; She has high fever that doesn't want to break; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break). At the time of the report, HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break) outcome was unknown. The action taken with mRNA-1273 in response to the event was not applicable. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1639533
Sex: U
Age:
State: WI

Vax Date: 03/03/2021
Onset Date: 03/03/2021
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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) in a 2-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding. MEDICAL HISTORY (Patient): No medical history was provided by the reporter. On 03-Mar-2021, the mother received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) had resolved. No Concomitant and Treatment medicines were Reported Action taken with mRNA-1273 in response to the event was not applicable This case was linked to MOD-2021-032346 (Parent-Child Link). See case MOD-2021-032346 for details regarding the Parent case.

Other Meds:

Current Illness:

ID: 1639535
Sex: U
Age:
State: VA

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: flu like symptoms for 3 days; 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 INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days) had resolved. No concomitant and treatment medications were provided

Other Meds:

Current Illness:

ID: 1639536
Sex: M
Age:
State: MN

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: Test Name: Platelet Count; Result Unstructured Data: Platelet Count decreased from 60,000 to 48,000

Allergies:

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

Symptoms: Platelet count decreased; This spontaneous case was reported by a physician and describes the occurrence of PLATELET COUNT DECREASED (Platelet count decreased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) tablet for Myelofibrosis. Concomitant products included CANNABIS, SIMETICONE (ALKA SELTZER ANTI GAS), IBUPROFEN, GABAPENTIN, OMEPRAZOLE, BISACODYL (DULCOLAX [BISACODYL]) and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelet count decreased). At the time of the report, PLATELET COUNT DECREASED (Platelet count decreased) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 48,000 (Low) Platelet Count decreased from 60,000 to 48,000. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medications was provided by the reporter.

Other Meds: CANNABIS; ALKA SELTZER ANTI GAS; IBUPROFEN; GABAPENTIN; OMEPRAZOLE; DULCOLAX [BISACODYL]; LISINOPRIL AND HYDROCHLOROTHIAZIDE; JAKAFI

Current Illness:

ID: 1639537
Sex: F
Age: 32
State: IL

Vax Date: 11/01/2020
Onset Date: 01/01/2021
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: SYR
Vax Site: LA

Lab Data: Test Date: 202101; Test Name: SARS-CoV-2 antibody test; Test Result: Negative ; Result Unstructured Data: Found that body did not develop antibodies.

Allergies:

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

Symptoms: Vaccine response impaired; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccine response impaired) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. In November 2020, the patient started UPADACITINIB (RINVOQ) (unknown route) 15 milligram. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In January 2021, the patient experienced VACCINATION FAILURE (Vaccine response impaired). At the time of the report, VACCINATION FAILURE (Vaccine response impaired) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: negative (Negative) Found that body did not develop antibodies.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. Company comment: This report refers to a case of vaccination failure for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: This report refers to a case of vaccination failure for mRNA-1273, lot # unknown with no associated AEs.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1639538
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: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Joint pain; fever; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (fever) and MYALGIA (Muscle ache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included SEMAGLUTIDE (OZEMPIC) and INSULIN DEGLUDEC (TRESIBA) for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (fever) and MYALGIA (Muscle ache). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (fever) and MYALGIA (Muscle ache) outcome was unknown. Concomitant medication not provided. Treatment medication not provided

Other Meds: OZEMPIC; TRESIBA

Current Illness:

ID: 1639539
Sex: F
Age:
State: GA

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

Symptoms: Lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of smell) 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 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. In 2021, the patient experienced ANOSMIA (Lost sense of smell). At the time of the report, ANOSMIA (Lost sense of smell) outcome was unknown. No concomitants medications was reported. No treatments medications was reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow-up included no new information.

Other Meds:

Current Illness:

ID: 1639540
Sex: F
Age:
State:

Vax Date:
Onset Date:
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: mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (mild reaction). At the time of the report, VACCINATION COMPLICATION (mild reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient's concomitant medications were not reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1639541
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: Second shot gave him a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Second shot gave him a bad headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Second shot gave him a bad headache). At the time of the report, HEADACHE (Second shot gave him a bad headache) had resolved. Reporter has mentioned, Patient's nephewhad really bad headache after second dose, and lasted for 12 hours and went away. No relevant Concomitant medications information was given by Reporter. No Treatment medication information was given by Reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1639542
Sex: F
Age:
State: TX

Vax Date: 04/01/2021
Onset Date: 05/01/2021
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: Test Date: 202105; Test Name: Increased blood pressure; Test Result: Inconclusive ; Result Unstructured Data: Patient reported blood pressure increased, from about 135 to 190 systolic.

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increased blood pressure) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced BLOOD PRESSURE INCREASED (increased blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (increased blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure increased: 135/190 (Inconclusive) Patient reported blood pressure increased, from about 135 to 190 systolic.. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1639543
Sex: U
Age:
State: OK

Vax Date:
Onset Date:
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: Grey phlegm; This spontaneous case was reported by a consumer and describes the occurrence of SPUTUM DISCOLOURED (Grey phlegm) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Heart disease, unspecified. 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 SPUTUM DISCOLOURED (Grey phlegm). At the time of the report, SPUTUM DISCOLOURED (Grey phlegm) outcome was unknown. No concomitant medication were reported. No treatment information was reported The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Reporter did not allow further contact

Other Meds:

Current Illness: Heart disease, unspecified

ID: 1639544
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: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: got my first shot yesterday and am experiencing chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (got my first shot yesterday and am experiencing chest 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 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced CHEST PAIN (got my first shot yesterday and am experiencing chest pain). At the time of the report, CHEST PAIN (got my first shot yesterday and am experiencing chest pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were provided

Other Meds:

Current Illness:

ID: 1639545
Sex: F
Age: 66
State: NV

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:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Can't walk; Can't bend down; Very dizzy; Fever; the head hurts; feel pain in the right arm/whole body hurts/pain below her hips; Pain below her hips; Patient can't do anything; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever) and HEADACHE (the head hurts) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 50AD27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included METOPROLOL, ATORVASTATIN, PROPAFENONE, VITAMIN B12 [VITAMIN B12 NOS], BORAGO OFFICINALIS OIL, FISH OIL, LINUM USITATISSIMUM OIL (TRIPLE OMEGA 3 6 9) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever), HEADACHE (the head hurts), MYALGIA (feel pain in the right arm/whole body hurts/pain below her hips), ARTHRALGIA (Pain below her hips) and FATIGUE (Patient can't do anything). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever), HEADACHE (the head hurts), MYALGIA (feel pain in the right arm/whole body hurts/pain below her hips), ARTHRALGIA (Pain below her hips) and FATIGUE (Patient can't do anything) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional information included updated outcome.

Other Meds: METOPROLOL; ATORVASTATIN; PROPAFENONE; VITAMIN B12 [VITAMIN B12 NOS]; TRIPLE OMEGA 3 6 9; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1639546
Sex: U
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Pretty negative reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Pretty negative reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 VACCINATION COMPLICATION (Pretty negative reaction). At the time of the report, VACCINATION COMPLICATION (Pretty negative reaction) outcome was unknown. No concomitant medications were provided No treatment medications were provided

Other Meds:

Current Illness:

ID: 1639547
Sex: F
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: She had a lot of reactions to the Moderna injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had a lot of reactions to the Moderna injection) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had a lot of reactions to the Moderna injection). At the time of the report, VACCINATION COMPLICATION (She had a lot of reactions to the Moderna injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1639548
Sex: F
Age: 47
State: KY

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:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was provided. No treatment drug details was included.

Other Meds:

Current Illness:

ID: 1639549
Sex: F
Age: 80
State: FL

Vax Date: 01/28/2021
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: She describe the rash as red and dark; Rash everywhere all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (She describe the rash as red and dark) and RASH (Rash everywhere all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 001A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and CLOPIDOGREL for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-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 (She describe the rash as red and dark) and RASH (Rash everywhere all over her body). At the time of the report, RASH ERYTHEMATOUS (She describe the rash as red and dark) and RASH (Rash everywhere all over her body) outcome was unknown. No Treatment Medications were reported.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; CLARITIN [CLARITHROMYCIN]; CLOPIDOGREL

Current Illness:

ID: 1639550
Sex: F
Age: 82
State: GA

Vax Date: 04/13/2021
Onset Date: 04/13/2021
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: Nausea, Pain in extremity, Pyrexia

Symptoms: A patient received 1st dose 65 days ago and hasn't received 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Concurrent medical conditions included BP, COPD and Diabetes. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was reported. Patient took 2nd dose on 17-jun-2021, Batch no. 014C21A, Intramuscular, LEFT DELTOID, with no Event reported in FU-1 Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU - Patient demographics provided, batch number provided, Reporter location

Other Meds:

Current Illness: BP; COPD; Diabetes

ID: 1639551
Sex: F
Age: 37
State: OK

Vax Date: 05/25/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: pain in arm; allergic reaction in left upper arm; edema; itching; developed bump around shot/progressing bumps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-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 PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps). The patient was treated with HISTAMINE at a dose of 1 dosage form and DEXAMETHASONE SODIUM PHOSPHATE (CORTICOIDEX) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product details was not reported. Oral Histamine and Corticoid cream were taken as Treatment medications. Patient was also applying cold compress. Patient scheduled for second dose next week at the time of reporting and the doctor suggested performing adjuvant testing to see if she has some type of allergic reaction. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received which contains no new information.

Other Meds:

Current Illness:

ID: 1639552
Sex: M
Age: 82
State: NJ

Vax Date: 03/03/2021
Onset Date: 03/03/2021
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: Full body rash/Still experiencing a rash; Sore arm (first dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (first dose)) and RASH (Full body rash/Still experiencing a rash) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (first dose)). On 06-Apr-2021, the patient experienced RASH (Full body rash/Still experiencing a rash). On 04-Mar-2021, PAIN IN EXTREMITY (Sore arm (first dose)) had resolved. At the time of the report, RASH (Full body rash/Still experiencing a rash) had not resolved. No Concomitant medications reported.No treatment medications reported. 3 more biopsy's completed and medical info agent name was Hiral Amin This case was linked to MOD-2021-225630 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up- Outcome of event- updated

Other Meds:

Current Illness:

ID: 1639553
Sex: F
Age: 57
State: FL

Vax Date: 03/19/2021
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: RA

Lab Data: Test Date: 20210430; Test Name: X-Ray; Test Result: Inconclusive ; Result Unstructured Data: Inflamation around rotator cuff tendon

Allergies:

Symptom List: Nausea

Symptoms: really bad pain and swelling in my left arm; really bad pain and swelling in my left arm; pain never goes away/started about 2 weeks after second vaccination/The patient states that the pain is worst in her left shoulder but is also very bad in her wrist, elbow, and entire left arm.; Range of motion is severely impacted in my left arm now, extending to my elbow with shooting pain down the arm.; I cannot dress myself easily, or exercise where any significant movement/rotation of my arm are needed.; inflamation around rotator cuff tendon; Injection site pain and swelling lingered with second vaccine injection; Injection site pain and swelling lingered with second vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad pain and swelling in my left arm), PERIPHERAL SWELLING (really bad pain and swelling in my left arm), PAIN (pain never goes away/started about 2 weeks after second vaccination/The patient states that the pain is worst in her left shoulder but is also very bad in her wrist, elbow, and entire left arm.), HYPOKINESIA (Range of motion is severely impacted in my left arm now, extending to my elbow with shooting pain down the arm.) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I cannot dress myself easily, or exercise where any significant movement/rotation of my arm are needed.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Drug allergy (Allergic to Cipromycin) and Thyroid disorder (Hyper/Hypo Thyroid) in 1991. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 PAIN IN EXTREMITY (really bad pain and swelling in my left arm), PERIPHERAL SWELLING (really bad pain and swelling in my left arm), PAIN (pain never goes away/started about 2 weeks after second vaccination/The patient states that the pain is worst in her left shoulder but is also very bad in her wrist, elbow, and entire left arm.), HYPOKINESIA (Range of motion is severely impacted in my left arm now, extending to my elbow with shooting pain down the arm.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I cannot dress myself easily, or exercise where any significant movement/rotation of my arm are needed.), ROTATOR CUFF SYNDROME (inflamation around rotator cuff tendon), VACCINATION SITE PAIN (Injection site pain and swelling lingered with second vaccine injection) and VACCINATION SITE SWELLING (Injection site pain and swelling lingered with second vaccine injection). The patient was treated with LIDOCAINE for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (really bad pain and swelling in my left arm), PERIPHERAL SWELLING (really bad pain and swelling in my left arm), PAIN (pain never goes away/started about 2 weeks after second vaccination/The patient states that the pain is worst in her left shoulder but is also very bad in her wrist, elbow, and entire left arm.), HYPOKINESIA (Range of motion is severely impacted in my left arm now, extending to my elbow with shooting pain down the arm.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I cannot dress myself easily, or exercise where any significant movement/rotation of my arm are needed.), ROTATOR CUFF SYNDROME (inflamation around rotator cuff tendon), VACCINATION SITE PAIN (Injection site pain and swelling lingered with second vaccine injection) and VACCINATION SITE SWELLING (Injection site pain and swelling lingered with second vaccine injection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, X-ray: inflamation around rotator cuff tendon. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up received. ADR form. Patient demographics, allergies, concomitant medication details and new events provided.

Other Meds: SYNTHROID; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1639554
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: immediately broke out in a rash (hives); First dose in April and still did not the take the second shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (immediately broke out in a rash (hives)) and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (immediately broke out in a rash (hives)) and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot). At the time of the report, URTICARIA (immediately broke out in a rash (hives)) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1639555
Sex: M
Age: 23
State: OH

Vax Date: 04/07/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: First dose administered 7Apr2021 - 2nd dose not administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose administered 7Apr2021 - 2nd dose not administered) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose administered 7Apr2021 - 2nd dose not administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose administered 7Apr2021 - 2nd dose not administered) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1639556
Sex: M
Age:
State: WA

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: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. no concomitant medications are provided.

Other Meds:

Current Illness:

ID: 1639557
Sex: U
Age:
State:

Vax Date: 05/01/2021
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: Tremor

Symptoms: Sniffles; A cold; 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 RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 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 RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold). At the time of the report, RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment medications were unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1639558
Sex: M
Age: 82
State: NJ

Vax Date: 03/03/2021
Onset Date: 03/31/2021
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: Erythema, Pruritus

Symptoms: Full body rash/ Still experiencing a rash; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sore arm), RASH (Full body rash/ Still experiencing a rash) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LIMB DISCOMFORT (Sore arm) and CHILLS (Chills). On 06-Apr-2021, the patient experienced RASH (Full body rash/ Still experiencing a rash). The patient was treated with PREDNISONE for Rash, at a dose of UNK, cyclical and FLUOCINONIDE (topical) for Rash, at a dose of 0.05 %. On 01-Apr-2021, LIMB DISCOMFORT (Sore arm) and CHILLS (Chills) had resolved. At the time of the report, RASH (Full body rash/ Still experiencing a rash) outcome was unknown. Lab data - Biopsy No concomitant medications provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received contains significant information. One event is not recovered. On 03-Aug-2021: Non-sig follow-up added.

Other Meds:

Current Illness:

ID: 1639559
Sex: F
Age: 82
State: IL

Vax Date: 03/03/2021
Onset Date: 04/01/2021
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: Test Name: x-ray; Result Unstructured Data: revealed arthritis

Allergies:

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

Symptoms: walking difficulty; arthritis; sciatic nerve pain/knees and shoulders are bone on bone; difficulty standing and walking; pain/more pain than she normally had; muscle pain; joint pain/more joint pain; fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone) and DYSSTASIA (difficulty standing and walking) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FALL (fall). On an unknown date, the patient experienced GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain). The patient was treated with CORTISONE in July 2021 for Adverse event, at a dose of cortisone injection in both knees. At the time of the report, FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: revealed arthritis (abnormal) revealed arthritis. Concomitant product use was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up contains additional events difficulty in standing, sciatic nerve pain and treatment product.

Other Meds:

Current Illness:

ID: 1639560
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Supposed to have second shot on 6/3 and missed date; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date) 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 (Supposed to have second shot on 6/3 and missed date). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were unknown. Patient received second dose on 17-JUN-2021 and had sore arm after second shot. This case was linked to MOD-2021-259904 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Followup received on 16-JUL-2021 contains no new information.

Other Meds:

Current Illness:

ID: 1639561
Sex: F
Age: 41
State: KY

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: Asthenia, Chills, Headache, Myalgia

Symptoms: Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No medical history 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 PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant information was provided. No Treatment information was provided.

Other Meds:

Current Illness:

ID: 1639562
Sex: F
Age: 70
State: AZ

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: 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: dose administered from a vial punctured over 24 hours before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from a vial punctured over 24 hours before) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) 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) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered from a vial punctured over 24 hours before). On 16-Jun-2021 at 3:00 AM, EXPIRED PRODUCT ADMINISTERED (dose administered from a vial punctured over 24 hours before) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product information reported.

Other Meds:

Current Illness:

ID: 1639563
Sex: F
Age: 67
State: OR

Vax Date: 03/09/2021
Onset Date: 04/06/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Sick). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Ache, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Ache, at a dose of 1 dosage form. At the time of the report, ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Treatment medication added, event added.

Other Meds:

Current Illness:

ID: 1639564
Sex: F
Age: 83
State: AZ

Vax Date: 01/22/2021
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: sore arm; a little tired; a little headache; a little nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (a little tired), HEADACHE (a little headache) and NAUSEA (a little nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Peripheral neuropathy (for the past 10 years). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (a little tired), HEADACHE (a little headache) and NAUSEA (a little nausea). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (a little tired), HEADACHE (a little headache) and NAUSEA (a little nausea) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant products were not provided. Treatment products were not provided. This case was linked to MOD-2021-225645 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcomes were updated.

Other Meds:

Current Illness: Peripheral neuropathy (for the past 10 years)

ID: 1639565
Sex: F
Age: 71
State: MN

Vax Date: 03/03/2021
Onset Date:
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: Falls asleep and sleeps for 4-5 hrs; sore arm felt like having a flu shot; Fatigue that is immense and overtakes her body, exhausted, tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 020B21A) for COVID-19 vaccination. The patient's past medical history included Lymph node excision (Ten lymph nodes were taken out due to cancer.). Concurrent medical conditions included Cancer. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired). At the time of the report, INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient stated that after receiving both doses of COVID vaccine, every week the patient had a blow out day where she could not function. Concomitant medication and treatment drug were not reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. This case was linked to MOD-2021-226976 (Patient Link).

Other Meds:

Current Illness: Cancer

ID: 1639566
Sex: M
Age: 28
State: KY

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: Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vial was opened on 15 Jun 2021 morning around 9:30am and was used for that day and then it was put back to refrigerator and then next day on 16JUN2021, it was taken out of refrigerator and was used from that vial between 10:40am-3:30pm No relevant concomitant medications were reported.. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1639567
Sex: M
Age: 48
State: FL

Vax Date: 04/23/2021
Onset Date: 04/23/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: This spontaneous case reported by a patient, describes the occurrence of pain in extremity (pain in the left arm) and pyrexia (a little bit of fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039B21A and 039C21A) for COVID-19 immunization. No medical history reported. On Apr 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 23, 2021, patient experienced pain in extremity (pain in the left arm) and pyrexia (a little bit of fever). Patient treated with Tylenol (paracetamol); unspecified dose and frequency. At the time of the report, pain in extremity (pain in the left arm) and pyrexia (a little bit of fever) outcome: unknown. Concomitant product use not provided. Patient did not receive any treatment after first dose of vaccine until second dose administration. This case linked to MOD-2021-225658 (patient link).

Other Meds:

Current Illness:

ID: 1639568
Sex: F
Age: 83
State: AZ

Vax Date: 03/10/2021
Onset Date: 03/10/2021
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: Sore arm; Tired for a couple weeks; Headache; Nausea; Peripheral neuropathy went away after 10 years; Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021), FATIGUE (Tired for a couple weeks) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Peripheral neuropathy (for the past 10 years; it was progressively getting worse.). On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea). On 10-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. No concomitant medications were reported. The patient had the same side effects as with her first dose but a little worse. No treatment information was provided. This case was linked to MOD-2021-225639 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcomes updated.

Other Meds:

Current Illness:

ID: 1639569
Sex: M
Age: 31
State:

Vax Date: 05/16/2021
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: Pain on my left arm; Diarrhea; literally defecated water while standing up showering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering). At the time of the report, PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering) outcome was unknown. This case was linked to MOD-2021-144428 (Patient Link).

Other Meds:

Current Illness:

ID: 1639570
Sex: F
Age: 57
State: KY

Vax Date: 01/12/2021
Onset Date: 02/23/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Pain spread to the entire body; Pain in the hip; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the hip) and MYALGIA (Pain spread to the entire body) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA) and SIMVASTATIN for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRALGIA (Pain in the hip) and MYALGIA (Pain spread to the entire body). The patient was treated with CORTISONE at an unspecified dose and frequency and MELOXICAM at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Pain in the hip) and MYALGIA (Pain spread to the entire body) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable Treatment information included two rounds of oral steroids.

Other Meds: OMEPRAZOLE; CYMBALTA; SIMVASTATIN

Current Illness:

ID: 1639571
Sex: F
Age: 66
State: FL

Vax Date: 05/23/2021
Onset Date: 05/23/2021
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: the legs hurt too; the whole body hurt; fell and hit her foot and knee; fell and hit her foot and knee; is not able to walk very well; felt very bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very bad), PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Cholesterol. On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 14-Jun-2021, the patient experienced JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well). On an unknown date, the patient experienced PAIN IN EXTREMITY (the legs hurt too) and MYALGIA (the whole body hurt). On 27-May-2021, FEELING ABNORMAL (felt very bad) had resolved. At the time of the report, PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee), GAIT INABILITY (is not able to walk very well) and MYALGIA (the whole body hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications included, medications for diabetes, cholesterol and burning/tingling feet associated to diabetes. Treatment information was not provided.

Other Meds:

Current Illness: Cholesterol; Diabetes

ID: 1639572
Sex: M
Age: 53
State: MI

Vax Date: 05/13/2021
Onset Date: 06/10/2021
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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Painful injection arm that is hard to lift above the head; Painful injection arm that is hard to lift above the head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful injection arm that is hard to lift above the head) and JOINT RANGE OF MOTION DECREASED (Painful injection arm that is hard to lift above the head) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21a and 048b21a) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful injection arm that is hard to lift above the head) and JOINT RANGE OF MOTION DECREASED (Painful injection arm that is hard to lift above the head). At the time of the report, PAIN IN EXTREMITY (Painful injection arm that is hard to lift above the head) and JOINT RANGE OF MOTION DECREASED (Painful injection arm that is hard to lift above the head) outcome was unknown. Patient reported no known allergies and not taking any concomitant medication Treatment information reported that patient not yet contacted his healthcare provider regarding the side effects and has not taken any medication to alleviate the pain

Other Meds:

Current Illness:

ID: 1639573
Sex: U
Age:
State:

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The red itches and has spread to above my elbow.; There is a large bump at the injection site and goes; It is dark red at the site where the needle was inserted.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.) 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-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.). At the time of the report, VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.) had not resolved. Hello PII(32):Aeq9Braioi0yJBuRYUX2iX2XzwooAA==. I received my 2nd vaccine on Thursday 6/3/21. I have a large red spot on my arm It is dark red at the site where the needle was inserted. The red itches and has spread to above my elbow. There is a large bump at the injection site and goes

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am