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: 1823484
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: thrombocytopenia; 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 THROMBOCYTOPENIA (thrombocytopenia) 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 THROMBOCYTOPENIA (thrombocytopenia). At the time of the report, THROMBOCYTOPENIA (thrombocytopenia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Patient stated it has shortened the patient life in 20 years now. Company comment- This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI of Thrombocytopenia. The event occurred an unknown amount of time after an unspecified dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from the event based on review of source document that did not include information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious of Thrombocytopenia. The event occurred an unknown amount of time after an unspecified dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from the event based on review of source document that did not include information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1823485
Sex: F
Age: 46
State: AZ

Vax Date: 08/22/2021
Onset Date: 09/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast; Feels like it's burning; Blisters; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast), BURNING SENSATION (Feels like it's burning), BLISTER (Blisters) and PRURITUS (Itching) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METOPROLOL, CHLORPROMAZINE, LOSARTAN and ALLOPURINOL for an unknown indication. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BLISTER (Blisters) and PRURITUS (Itching). On 18-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast) and BURNING SENSATION (Feels like it's burning). At the time of the report, VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast) and BURNING SENSATION (Feels like it's burning) outcome was unknown and BLISTER (Blisters) and PRURITUS (Itching) had resolved. Treatment information was not provided. After the second dose patient experienced the reaction in different part of the body, in the arms, on the face and on the breast. It's where it gets the reactions most. After the itches went away it burns where the blisters was and lasts 1 or two minutes. Doesn't know if it's because of the itch. Patient Felts l it was like burning. This case was linked to MOD-2021-358723 (Patient Link).

Other Meds: METOPROLOL; CHLORPROMAZINE; LOSARTAN; ALLOPURINOL

Current Illness:

ID: 1823486
Sex: F
Age: 88
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Moderna COVID-19 vaccine that was refrigerated for more than 30 days was administered to the patient. The vaccine was defrosted in 30-Aug-2021 and it was administered on 01-Oct-2021. This case was linked to MOD-2021-358921, MOD-2021-358735, MOD-2021-358779, MOD-2021-358800, MOD-2021-358865, MOD-2021-359032, MOD-2021-359764, MOD-2021-359183, MOD-2021-358799, MOD-2021-358841, MOD-2021-358753 (Patient Link).

Other Meds:

Current Illness:

ID: 1823487
Sex: M
Age: 55
State: GA

Vax Date: 09/11/2021
Onset Date: 10/09/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: midnight he had vertigo once; Soreness at the injection site; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (midnight he had vertigo once), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 014F21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache). On 18-Oct-2021, the patient experienced VERTIGO (midnight he had vertigo once). In October 2021, VERTIGO (midnight he had vertigo once) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) outcome was unknown. Treatment medications included Antibiotic and steroids. This case was linked to MOD-2021-358840 (Patient Link).

Other Meds: FLONASE [FLUTICASONE PROPIONATE]; ALLEGRA

Current Illness:

ID: 1823488
Sex: U
Age:
State: NC

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment medications were reported. It was reported that the vial did not undergo any temperature excursions.

Other Meds:

Current Illness:

ID: 1823489
Sex: F
Age: 63
State: MI

Vax Date: 03/23/2021
Onset Date: 04/21/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: X-ray; Result Unstructured Data: confirmed with arthritis

Allergies:

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

Symptoms: Arthritis/might be my arthritis; Couldn't move/slowing down my walking and cleaning up; Hard time sleeping; Very tense; Very painful/pain similar to shingles almost; Joint pain/feel it all over my joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis/might be my arthritis), MOBILITY DECREASED (Couldn't move/slowing down my walking and cleaning up), INSOMNIA (Hard time sleeping), TENSION (Very tense) and PAIN (Very painful/pain similar to shingles almost) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included MELOXICAM for Arthritis, CALCIUM, COLECALCIFEROL (VITAMIN D3), VITAMIN C [ASCORBIC ACID], MAGNESIUM, FISH OIL (OMEGA-3 FISH OIL), ZINC and PARACETAMOL (TYLENOL) for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Joint pain/feel it all over my joints). On an unknown date, the patient experienced ARTHRITIS (Arthritis/might be my arthritis), MOBILITY DECREASED (Couldn't move/slowing down my walking and cleaning up), INSOMNIA (Hard time sleeping), TENSION (Very tense) and PAIN (Very painful/pain similar to shingles almost). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Arthritis/might be my arthritis), MOBILITY DECREASED (Couldn't move/slowing down my walking and cleaning up), INSOMNIA (Hard time sleeping), TENSION (Very tense), PAIN (Very painful/pain similar to shingles almost) and ARTHRALGIA (Joint pain/feel it all over my joints) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) confirmed with arthritis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication involves Muscle relaxer and sleeping pills. This case concerns a 63 year old female with no reported medical history who experienced non-serious expected event of arthralgia on the 2nd day after vaccination with the 2nd dose of mRNA-1273 (Moderna) . On an unknown date she experienced non-serious unexpected events of Mobility decreased, , Arthritis, , Insomnia , Pain and Tension after vaccination with the 2nd dose. The re-challenge for this case is not applicable. The age of the patient is a confounder for this case (Aging process can cause bone problems that may cause joint pains) . The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.; Sender's Comments: This case concerns a 63 year old female with no reported medical history who experienced non-serious expected event of arthralgia on the 2nd day after vaccination with the 2nd dose of mRNA-1273 (Moderna) . On an unknown date she experienced non-serious unexpected events of Mobility decreased, , Arthritis, , Insomnia , Pain and Tension after vaccination with the 2nd dose. The re-challenge for this case is not applicable. The age of the patient is a confounder for this case (Aging process can cause bone problems that may cause joint pains) . The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.

Other Meds: MELOXICAM; CALCIUM; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; MAGNESIUM; OMEGA-3 FISH OIL; ZINC; TYLENOL

Current Illness:

ID: 1823490
Sex: M
Age:
State: MD

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 test; Test Result: Positive; Result Unstructured Data: positive.

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Tested positive for COVID after the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID after the first dose of the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced COVID-19 (Tested positive for COVID after the first dose of the vaccine). At the time of the report, COVID-19 (Tested positive for COVID after the first dose of the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information were not provided. Concomitant medications were not provided. This case concerns a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event COVID-19 occurred approximately one to two weeks after the first dose of Spikevax. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event COVID-19 occurred approximately one to two weeks after the first dose of Spikevax. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1823491
Sex: M
Age: 37
State: TX

Vax Date: 10/19/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 202110; Test Name: Blood pressure; Result Unstructured Data: 148/94; Test Date: 202110; Test Name: pulse rate; Result Unstructured Data: pulse rate of 86

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: soreness of the Left Arm (vaccination site); wheezing; rash in the groin area; said he is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (said he is not feeling well), WHEEZING (wheezing), RASH (rash in the groin area) and VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The patient's past medical history included Asthma (He had no attacks for 10 years now. But he has one Asthma Inhaler for emergency purposes.). On 19-Oct-2021 at 6:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced MALAISE (said he is not feeling well). On 19-Oct-2021, the patient experienced WHEEZING (wheezing) and RASH (rash in the groin area). On 19-Oct-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)). At the time of the report, MALAISE (said he is not feeling well) and WHEEZING (wheezing) had not resolved and RASH (rash in the groin area) and VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: 148/94 (abnormal) 148/94. In October 2021, Heart rate: 86 (normal) pulse rate of 86. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient used his unspecified Asthma inhaler for the event wheezing.

Other Meds:

Current Illness:

ID: 1823492
Sex: F
Age: 67
State: PA

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Sickness; Had no energy; I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes; I had the worst headache of my life/ feeling headache; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Sickness), ASTHENIA (Had no energy), FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) and HEADACHE (I had the worst headache of my life/ feeling headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 018B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN B12 [VITAMIN B12 NOS], SUCRALFATE (CARAFATE), VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-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 ILLNESS (Sickness), ASTHENIA (Had no energy), FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) and HEADACHE (I had the worst headache of my life/ feeling headache). At the time of the report, ILLNESS (Sickness), ASTHENIA (Had no energy) and HEADACHE (I had the worst headache of my life/ feeling headache) had resolved and FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-358790 (Patient Link).

Other Meds: Protonix [Omeprazole]; Vitamin B12 [Vitamin B12 Nos]; Carafate; Calan [Verapamil Hydrochloride]; Antivert [Meclozine Hydrochloride]

Current Illness:

ID: 1823493
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: 6 patients administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) 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 EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1823494
Sex: F
Age: 49
State: WA

Vax Date: 09/09/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Less than 26 days for administration of second dose; This spontaneous case was reported by a physician assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 939906) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1823495
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: got the 2nd dose beyond the approved time frame in refrigerator; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator) in an adult 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, 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 EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator) had resolved. No concomitant medications was reported. No treatment drug details was reported. Age of the patient was mentioned as mid 20s but not provided exactly. This case was linked to MOD-2021-358910 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1823496
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: heart flip-flopped; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart flip-flopped) 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 PALPITATIONS (heart flip-flopped). At the time of the report, PALPITATIONS (heart flip-flopped) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1823497
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: sick for a week; flu like symptoms for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week) 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 ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week). At the time of the report, ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. no concomitant medications are provided, treatment to the events given as laid in bad. This case was linked to MOD-2021-358900 (Patient Link).

Other Meds:

Current Illness:

ID: 1823498
Sex: F
Age: 68
State: FL

Vax Date: 09/22/2021
Onset Date: 09/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: heat/hot; rash on my upper arm where the injection site was/spread across the upper arm; red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE RASH (rash on my upper arm where the injection site was/spread across the upper arm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included METFORMIN and ENALAPRIL for an unknown indication. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE RASH (rash on my upper arm where the injection site was/spread across the upper arm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy). The patient was treated with HYDROCORTISONE from September 2021 to September 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE RASH (rash on my upper arm where the injection site was/spread across the upper arm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) 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. Patient had also taken the supplement of Vitamin B and D3 once a day as a concomitant medication.

Other Meds: METFORMIN; ENALAPRIL

Current Illness:

ID: 1823499
Sex: M
Age: 82
State: IL

Vax Date: 02/02/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Not immunocompromised and received full third dose of 0.5ml; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00F421A, 038K20A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Parkinsonism. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml). On 19-Oct-2021, OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml) had resolved. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-358835 (Patient Link).

Other Meds:

Current Illness: Parkinsonism

ID: 1823500
Sex: F
Age: 75
State: IN

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: I had a fever of 102 degrees Fahrenheit

Allergies:

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

Symptoms: Arm pain; I was sicker than a dog; If I rub on left arm, site of injection hurts when touched; After the third dose my arm was incredibly sore, I couldn't lift my arm; I had a fever of 102 degrees Fahrenheit; I had chills which lasted 24 to 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm) and PYREXIA (I had a fever of 102 degrees Fahrenheit) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 030L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched) had not resolved and MALAISE (I was sicker than a dog), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) I had a fever of 102 degrees Fahrenheit. The patient reported that they didn't had any side effects with the first two doses, but they did feel incredibly sore and was not able to lift their arm after the third dose. Reportedly, the patient had a fever, chills, and arm pain and most symptoms had resolved except the arm pain.

Other Meds: ALENDRONATE

Current Illness:

ID: 1823501
Sex: F
Age: 63
State: OH

Vax Date: 03/11/2021
Onset Date: 04/08/2021
Rec V Date: 10/28/2021
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: band-aid mark on the injection site (right arm); pea-size lymph node on her neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)) and LYMPHADENOPATHY (pea-size lymph node on her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (pea-size lymph node on her neck). On an unknown date, the patient experienced VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)). At the time of the report, VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)) had resolved and LYMPHADENOPATHY (pea-size lymph node on her neck) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-358991 (Patient Link).

Other Meds:

Current Illness:

ID: 1823502
Sex: M
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: My son experienced mild myocarditis, with tightness in his throat and chest; with tightness in his throat and chest; with tightness in his throat and chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (My son experienced mild myocarditis, with tightness in his throat and chest) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (My son experienced mild myocarditis, with tightness in his throat and chest) (seriousness criterion medically significant), CHEST DISCOMFORT (with tightness in his throat and chest) and OROPHARYNGEAL DISCOMFORT (with tightness in his throat and chest). At the time of the report, MYOCARDITIS (My son experienced mild myocarditis, with tightness in his throat and chest), CHEST DISCOMFORT (with tightness in his throat and chest) and OROPHARYNGEAL DISCOMFORT (with tightness in his throat and chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. Company Comment: This case concerns a male patient with unknown age and no relevant medical history, who experienced the serious expected event of myocarditis and non-serious unexpected events of chest discomfort and oropharyngeal discomfort. The events occurred on an unknown date after a dose of Spikevax. The rechallenge was assessed as not applicable as the dose number was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Sender's Comments: This case concerns a male patient with unknown age and no relevant medical history, who experienced the serious expected event of myocarditis and non-serious unexpected events of chest discomfort and oropharyngeal discomfort. The events occurred on an unknown date after a dose of Spikevax. The rechallenge was assessed as not applicable as the dose number was unknown. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1823503
Sex: F
Age: 72
State: FL

Vax Date: 08/26/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain in her right leg; sadness; feels like her body is burning; dizziness; not feeling good; shingles on the left side of her mouth; couldn't open her mouth; depression; burning gums; stomach issues; can't sleep; can't go to the bathroom; only wanting to sleep; vomiting; nausea/nauseas so strong she couldn't eat; fever that wouldn't leave; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, and FEELING ABNORMAL in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012f21a and 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CARVEDILOL, VITAMIN D, VITAMIN C, and VITAMIN E for an unknown indication. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-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 PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA outcome was unknown. Patient reported treatment medication as antibiotics, ice pack, and tea Patient reported use of concomitant medication high blood pressure medicine.

Other Meds: CARVEDILOL; VITAMIN D; VITAMIN C; VITAMIN E

Current Illness:

ID: 1823504
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: really bad side effects after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really bad side effects after the second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (really bad side effects after the second dose). In 2021, VACCINATION COMPLICATION (really bad side effects after the second dose) had resolved. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-358977, MOD-2021-359049 (Patient Link).

Other Meds:

Current Illness:

ID: 1823505
Sex: U
Age:
State: AL

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Patients received dose from a punctured vials in the refrigerator for days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose from a punctured vials in the refrigerator for days) 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 EXPIRED PRODUCT ADMINISTERED (Patients received dose from a punctured vials in the refrigerator for days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received dose from a punctured vials in the refrigerator for days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment medications were reported. It was reported that patients were vaccinated with vaccine which was punctured for more than 6 hours and placed back into the refrigerator for multiple days. It was not confirmed whether it was first or second dose of vaccine.

Other Meds:

Current Illness:

ID: 1823506
Sex: M
Age:
State: NJ

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient administered an expired vaccine.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Oct-2021 and was forwarded to Moderna on 20-Oct-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Oct-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 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications are provide by the reporter. On 15-oct-2021 vaccine moved to refrigeration, used by on 13-oct-2021. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Non significant follow up received

Other Meds:

Current Illness:

ID: 1823507
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date: 04/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210818; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose; Fatigue; Sneezing; Tingle; Kind of dizzy spell when had the vaccine; Had an stomach flu or something like that and tested negative; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine), GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and FATIGUE (Fatigue) in a female patient of an unknown age 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PARAESTHESIA (Tingle) and DIZZINESS (Kind of dizzy spell when had the vaccine). In April 2021, the patient experienced GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative). On 18-Aug-2021, the patient experienced SNEEZING (Sneezing) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose). At the time of the report, SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine) and FATIGUE (Fatigue) outcome was unknown and GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: negative (Negative) Negative. On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided. The patient reported that she was sure that had COVID since she had all the symptoms.

Other Meds:

Current Illness:

ID: 1823508
Sex: U
Age:
State:

Vax Date: 08/31/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Reaction starting the day after my 2 nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction starting the day after my 2 nd dose) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00721A) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-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 VACCINATION COMPLICATION (Reaction starting the day after my 2 nd dose). At the time of the report, VACCINATION COMPLICATION (Reaction starting the day after my 2nd dose) outcome was unknown. Not Provided. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1823509
Sex: F
Age: 26
State: TX

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20211018; Test Name: Body temperature

Allergies:

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

Symptoms: Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 97.9 normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1823510
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Pain; Headache; 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 PAIN (Pain) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and HEADACHE (Headache). At the time of the report, PAIN (Pain) and HEADACHE (Headache) 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 reported. No treatment medications reported.

Other Meds:

Current Illness:

ID: 1823511
Sex: F
Age: 48
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: qualitative IgG; Test Result: Positive ; Result Unstructured Data: strongly positive; Test Date: 20210105; Test Name: Chest X-ray; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 202109; Test Name: echo; Result Unstructured Data: normal; Test Date: 20210105; Test Name: EKG; Result Unstructured Data: tachycardia of 120 and some PVCs; Test Date: 20210104; Test Name: heart rate; Result Unstructured Data: heart rate was in the 120s, 130s; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: remained elevated whether walking her dog, up and down the stairs, laying down and getting up, lasted for 5 days; Test Date: 20210311; Test Name: Serology; Result Unstructured Data: had great titers

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: exhausted; tingling in my lungs; freezing cold metal sensation in my throat; tachycardia; discomfort / uncomfortable; aching in my chest; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest) in a 48-year-old female 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. Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021 at 11:00 PM, the patient experienced PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest). On 05-Jan-2021, the patient experienced FATIGUE (exhausted). In January 2021, PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable), CHEST PAIN (aching in my chest) and FATIGUE (exhausted) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: increased (High) heart rate was in the 120s, 130s. On 05-Jan-2021, Chest X-ray: negative (Negative) Negative. On 05-Jan-2021, Electrocardiogram: abnormal (abnormal) tachycardia of 120 and some PVCs. On 11-Mar-2021, Serology test: abnormal (abnormal) had great titers. In 2021, Blood immunoglobulin G: positive (Positive) strongly positive. In 2021, Heart rate: high (High) remained elevated whether walking her dog, up and down the stairs, laying down and getting up, lasted for 5 days. In September 2021, Echocardiogram: normal (normal) normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication reported.

Other Meds: TYLENOL 8 HOUR; BENADRYL 24 D

Current Illness:

ID: 1823512
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: chills; fatigue; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 01Oct2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 40 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 and dose 2 on unspecified date(s), batch/lot and expiries unknown, both as a single dose for COVID 19 immunization. Medical history and concomitant products were not reported. The patient had received his first dose as of 05Jan2021. The patient reported he experienced chills and fatigue with the first 2 doses. The outcome of the events was unknown. He subsequently received the 3rd dose/ booster of BNT162B2 on 28Sep2021. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101301634 same patient, similar events with dose 3

Other Meds:

Current Illness:

ID: 1823513
Sex: F
Age:
State: MI

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20210617; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Nausea

Symptoms: a lump in that arm/Second dose: lump stayed about the same; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration in left arm on 29Mar2021 at 9:00AM or 10:00AM (at the age of 68 years old) as dose 2, single for covid-19 immunisation. Medical history included thyroid disorder, paroxysmal nocturnal hemoglobinuria. Concomitant medications included ravulizumab cwvz (ULTOMIRIS [RAVULIZUMAB CWVZ]) infusion every 8 weeks taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (Lot number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at 10:00 AM (at the age of 68 years old) for covid-19 immunisation and patient experienced swelling in her left arm, her left arm hurt, lump in her left arm at the injection site, arm was hurting at the injection site, benign lump on that left side, lump in left arm is like a mass or oval, swelled a little, not a lot but it was swollen for about 2 weeks, having pain in her left arm off and on, sometimes the lump in her left arm feels larger than other times. The patient previously received flu vaccine, pneumonia vaccine, meningitis vaccine and has never gotten a lump or anything like that. She received her second dose at the end of Mar2021 and she didn't have any side effects. no pain or anything. After the second Covid 19 vaccine the a lump in that arm/lump stayed about the same, it didn't get worse. She has had the second dose of the vaccine in the left arm as well but in a slightly different area, no date was provided by caller of the second dose. Sometimes the lump in her left arm feels larger than other times. She doesn't know. She reports she received both doses in her left arm but the second dose the site was a little upper, a different part in her left arm. She had the ultrasound of the injection site in her left arm on 17Jun2021 and it came back that the lump was benign but she did not get any other information. The doctor told her if it gets worse than to call back. The nurse at the health department mentioned that there have been side effects with lymph nodes but the caller has never had a lump in her arm before. The patient underwent lab tests and procedures which included ultrasound scan: unknown on 17Jun2021. The outcome of event was not recovered. Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: ULTOMIRIS [RAVULIZUMAB CWVZ]

Current Illness:

ID: 1823514
Sex: M
Age:
State:

Vax Date: 07/13/2021
Onset Date: 07/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: he developed a lump on his neck; This is a spontaneous report from a contactable consumer reporting for a patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration on 13Jul2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose for covid-19 immunisation. On an unspecified date in Jul2021, the patient experienced 2 days after the second dose of the Pfizer vaccine, slowly he developed a lump on his neck. After 3 days, It's much reduced. The outcome of event was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1823515
Sex: M
Age:
State: ME

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20210129; Test Name: Fever; Result Unstructured Data: Test Result:99.7 Fahrenheit; Comments: 11:45; Test Date: 20210130; Test Name: Fever; Result Unstructured Data: Test Result:98.3 Fahrenheit; Comments: 07:15; Test Date: 20210130; Test Name: Fever; Result Unstructured Data: Test Result:99.4 Fahrenheit; Comments: 01:45; Test Date: 20210130; Test Name: Fever; Result Unstructured Data: Test Result:98.8 Fahrenheit; Comments: 04:30; Test Date: 20210130; Test Name: Fever; Result Unstructured Data: Test Result:98.4 Fahrenheit; Comments: 09:30; Test Date: 20210131; Test Name: Fever; Result Unstructured Data: Test Result:98.5 Fahrenheit; Comments: 04:15; Test Date: 20210131; Test Name: Fever; Result Unstructured Data: Test Result:95.7 Fahrenheit; Comments: 06:30; Test Date: 20210201; Test Name: Fever; Result Unstructured Data: Test Result:99.8 Fahrenheit; Comments: 13:15; Test Date: 20210201; Test Name: Fever; Result Unstructured Data: Test Result:98.7 Fahrenheit; Comments: 06:00; Test Date: 20210202; Test Name: Fever; Result Unstructured Data: Test Result:98 Fahrenheit; Comments: 04:00

Allergies:

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

Symptoms: injection site pain; feeling unwell; lost weight; joint pain; fever; very thirsty after 2 hr; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318) via intramuscular route of administration, administered in left deltoid (at age of vaccination 74) on 28Jan2021 as dose 1, single for COVID-19 immunization (School/ Student Health clinic). The patient medical history included baker cyst bunion and simple renal cyst from 01Jun2010, osteoarthritis and nocturia from 04May2012, hypertensive disorder and hyperlipidemia from 11Jun2010, chronic prostatitis and interstitial cystitis from 23Nov2013, degenerative arthritis of knee from 05May2012. The patient concomitant medications included acetylsalicylic acid (ASPIRIN 81), Atorvastatin, Cholecalciferol, Hydrochlorothiazide, Losartan and Tamsulosin taken for unspecified indication and start date and stop date was not reported. On an unspecified date, the patient experienced injection site pain, feeling unwell, lost weight, joint pain, fever and very thirsty after 2 hr. The patient underwent lab tests and procedures which included body temperature 99.7F (29Jan2021, 11:45), 98.3F (30Jan2021, 7:15), 99.4F (30Jan2021, 01:45), 98.8F (30Jan2021, 4:30), 98.4F (30Jan2021, 9:30), 98.5F (31Jan2021, 04:15), 95.7F (31Jan2021, 06:30), 99.8F (01Feb2021, 13:15), 98.7 (01Feb2021,06:00), 98F (02Feb2021, 04:00). The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: ASPIRIN 81; ATORVASTATIN; CHOLECALCIFEROL; HYDROCHLOROTHIAZIDE; LOSARTAN; TAMSULOSIN

Current Illness:

ID: 1823516
Sex: U
Age:
State: TX

Vax Date: 05/18/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itching has gotten worse; broke out in hives and welps; My skin is still inflamed and painful; My skin is still inflamed and painful; I cant eat or sleep well due to the pain and itching; I cant eat or sleep well due to the pain and itching; This is a spontaneous report from a contactable consumer. This consumer reported for a patient in response to non-HCP letter send in cross reference case that included: A 54 years-old female patient received bnt162b2 (COMIRNATY; Lot Number; EW0178) Intramuscular administered in Arm Left on 18May2021 at 09:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient received second dose of bnt162b2 (COMIRNATY; Lot Number; EW0181) Intramuscular administered on 19Jun2021 at 16:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none reported. Concomitant medications were none reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date the patient experienced that the week before I received my first vaccine dose, I was working in my garden and bitten by Chiggers. Once I got the vaccine, the itching become more intense, burning and painful. After about 10days on 29May. I went to the E.R. The doctor said he couldn't give me anything because i'd taken the vaccine for Covid. He also said that I should take the 2nd dose because it's better than dying from Covid. On his advice, I took the second dose/vaccine, and the itching has gotten worse. I broke out in Hives and welps. My skin is still inflamed of painful after (3) weeks since getting my second dose. I can't eat or sleep over due to the pain of itching. The patient visited emergency room due to events. The patient did not receive treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1823517
Sex: M
Age:
State: CA

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

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

Lab Data: Test Name: estrogen; Result Unstructured Data: Test Result:30; Test Name: Testosteron; Result Unstructured Data: Test Result:under 200; Comments: Low; Test Name: BMI; Result Unstructured Data: Test Result:24; Comments: so I am just underneath the threshold of being overweight; Test Name: chromosome; Result Unstructured Data: Test Result:XXY; Comments: I have been XXY chromosome variant; Test Name: Weight; Result Unstructured Data: Test Result:threshold of being overweight; Comments: threshold of being overweight

Allergies:

Symptom List: Tremor

Symptoms: Axillary lymphadenitis; Leg pain; Foggy feeling in head; Tiredness; Vertigo; Confusion state; Dizzy; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 27Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable nurse (patient) and a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR control no.: 21K-163-4051163-00). A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via intramuscular route, administered in Arm Right on an unspecified date (at the age of 32-years-old) as dose 1, single for covid-19 immunization; testosterone, via topical route from an unspecified date (Lot number: unknown) to an unspecified date, at 5 g for an unspecified indication. Medical history included XXY chromosome variant and does not produce testosterone hormones like other peoples; both are ongoing. Other medication and medical conditions included: chromosome disorder - consumer stated that he was born with extra female chromosome. He had XXY chromosome variant, so the men are born with XY, women are born with XX chromosomes. The patient was born with XXY chromosome, so he had under 200 testosterone, 30 estrogen and his body doesn't produce hormones like other peoples or 'approach systems' (Further clarification was unknown). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced axillary lymphadenitis, leg pain, foggy feeling in head, tiredness, vertigo, confusion state, dizzy. Clinical course included: the patient had the Pfizer and after the first week the patient had a huge, inflamed lymph node in armpit; armpit lymph node got inflamed, leg pain and then the patient went to get the second dosage and had a more severe leg pain and a brain fog for about 2 and a half months. Patient would like to report the bad side effects. After about 2 weeks of taking it (testosterone), after the second dosage the patient started feeling dizzy which kind of sucks, feel retarded like had a concussion or stroke or high-altitude sickness like less oxygen in the brain, just feel kind of gazed or confused or feel extremely tired, tiredness, vertigo. About age consumer reported that like 2 or 3 months ago he got the full vaccine; he does not know if that matters, and its 33. (Not appropriately clarified, hence not captured in tab). About weight consumer reported that it was about 24 BMI, so he was just underneath the threshold of being overweight. (Further clarification unknown). About treatment consumer stated that while he was on Pfizer for the both terms of taking the dosage (Further clarification was unknown), he was taking Testosterone 5 gm, 1 percent (1%) Testosterone (Dosage were not appropriately clarified), a gel on both of arms but then after about 2 weeks of taking it (Testosterone), after the second dosage he started feeling dizzy which kind of sucks (Hence Testosterone was conservatively captured as suspect) because he need that medicine to basically hormones (incomplete sentence) but then Pfizer is making him dizzy so that kind of blows. So basically steroids he guess can call it (incomprehensible voice) stopped. About site of vaccination consumer stated, first one in right arm and then his armpit lymph node got inflamed, it was not inflamed by anything else, it was inflamed by the vaccine and then he took the second dosage in left arm. The pharmacist who injected it didn't clarify or specify about getting on the same arm, he told her he was getting on the left arm this time, she giggled so it doesn't matter which arm. Consumer further stated that he had symptoms such as brain fog, usually a kind of feel retarded like had a concussion or stroke or high-altitude sickness like less oxygen in the brain, just feel kind of gazed or confused or feel extremely tired. He had that about 2 months and a family member who got the Pfizer also had the same symptoms and then another family member who had patient's DNA another sibling also has the same effects. One of his friend who also got the Pfizer, patient talked to him, he also got the same symptoms (Further details were not available over the call, hence split case was not made). The patient doesn't know if there's a bad batch in (place), got like a horrible batch of Pfizer he has no clue, he do not know if it got mixed with something else (Further clarification was unknown). All had tiredness, went to sleep for 8 hours, wake up for 2 or 3 hours, and get some coffees, then were really tired, then have to lay in bed and deal with vertigo until you (incomplete sentence). The patient underwent lab tests and procedures which included blood oestrogen: 30 on an unspecified date, blood testosterone: under 200 on an unspecified date, body mass index: 24 (just underneath the threshold of being overweight) on an unspecified date, chromosomal analysis: XXY chromosome variant on an unspecified date, weight: threshold of being overweight on an unspecified date. The action taken in response to the events for testosterone was unknown. The outcome of events axillary lymphadenitis, leg pain, foggy feeling in head, tiredness, vertigo, confusion state, dizzy was unknown. Causality for testosterone - the reporter's causality for the event(s) of huge, inflamed lymph node in armpit by pfizer vaccine, leg pain, brain fog, tiredness, vertigo, felt kind of gazed or confused and feeling dizzy was not provided. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness: Testosterone deficiency; XXY syndrome

ID: 1823518
Sex: F
Age:
State: KY

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Have occasional chest pains when sitting up breathing normal.; when take a deeper breath it would be more uncomfortable.; This is a spontaneous report from a contactable healthcare professional. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 12:15 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, heart problems as a premature baby and premature baby. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 03Aug2021 at 13:30, the patient had occasional chest pains when sat up breathing normal and when taking a deeper breath, it would be more uncomfortable. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had occasional chest pains when sat up breathing normal and when taking a deeper breath, it would be more uncomfortable was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1823519
Sex: F
Age:
State: OH

Vax Date: 08/04/2021
Onset Date: 08/07/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swelling at the injection site; There is a lump and it is slightly warm to the touch; Swelling underneath the arm of the injection site and at the breast area near the armpit; There is a lump and it is slightly warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration on 04Aug2021 at 13:30 (on Wednesday, at the age of 52-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High Blood pressure. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for hypertension, start and stop date were not reported; naproxen (NAPROXEN) taken for pain, start and stop date were not reported. On 07Aug2021 (more towards to the noon), the patient experienced swelling at the injection site, there is a lump and it is slightly warm to the touch, swelling underneath the arm of the injection site and at the breast area near the armpit, there is a lump and it is slightly warm to the touch. No treatment was received for events. The outcomes of events were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: AMLODIPINE; NAPROXEN

Current Illness:

ID: 1823520
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/06/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe body pain; migraine; fever; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. On 06Aug2021, the patient experienced severe body pain, migraine, fever and vomiting. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body pain, migraine, fever and vomiting were unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1823521
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Severe menstrual cramps few hours after the shot; Period started 4 days earlier; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 07Aug2021 at 14:00, few hours after the shot, the patient experienced severe menstrual cramps and the patient's period started 4 days earlier. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe menstrual cramps and period started 4 days earlier were not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1823522
Sex: M
Age:
State: WV

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

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

Lab Data:

Allergies:

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

Symptoms: pain in shoulders/ Pain continue to migrate to elbow's, hands, wrists and feet; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not provided), via unspecified route as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. On an unknown date, the patient experienced pain continued to migrate from shoulders to elbows, hands, wrist and feet not as severe. The outcome of the events were unknown. No follow up attempts were possible. Information about lot/batch number cannot be requested.

Other Meds:

Current Illness:

ID: 1823523
Sex: F
Age:
State: UT

Vax Date: 07/30/2021
Onset Date: 07/31/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lump under left arm, left breast pain.; left breast pain.; neck also got swollen; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0198) via an unspecified route of administration, administered in arm left on 30Jul2021 at 09: 15 (at the age of 39-years-old) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had not received any other vaccine in four weeks. Concomitant medications included famotidine and ketoconazole (in two weeks). Patient's past drug included Percocet and she had Known allergy with Percocet. On 31Jul2021, the patient experienced lump under left arm and left breast pain and neck also got swollen. The patient visited doctor or other healthcare professional office/clinic visit and emergency room as result in the events. The patient reported that the day after 1st dose my armpit got swollen and painful. The patient reported that the day after 1st dose her armpit got swollen and painful. This lasted for weeks, her neck also got swollen, she also experienced breast pain, visited doctor the day before 2nd dose on 19Aug2021. The outcome of the events lump under left arm, left breast pain was not recovered. The outcome of the event neck also got swollen was unknown.

Other Meds: FAMOTIDINE; KETOCONAZOLE

Current Illness:

ID: 1823524
Sex: F
Age:
State:

Vax Date: 03/30/2021
Onset Date: 03/31/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20210331; Test Name: temperature; Result Unstructured Data: Test Result:102.3; Test Date: 202104; Test Name: temperature; Result Unstructured Data: Test Result:100-101?; Test Date: 20210407; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Pain in extremity

Symptoms: fever (tmax 102.3)/I am continuing to have fevers at night. Around 100-101?.; dry cough; chills; nausea; This is a spontaneous report from a non- contactable nurse (patient). A 29-year-old Non-Pregnant female patient received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: ER8734) via an unspecified route of administration in left arm on 30Mar2021 (At the age of 29-year-old) as Dose 2, Single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patients medical history and concomitant medications were not reported. Historical vaccine included the patient previously received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: EN6198) via an unspecified route of administration on 09Mar2021 (At the age of 29-year-old) as Dose 1, Single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. the patient was not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 31Mar2021 the patient experienced as expected, about 16 hours later, she developed chills, fever (tmax 102.3) and nausea. The fever resolved with Tylenol. Over the next few days, Thursday, Friday, the weekend and now Monday, she continuing to have fevers at night. Around 100-101?. she did also develop a dry cough, which is non-productive. About a week after her first injection, she did notice that the muscle on the right side of my neck was sore to the point where it hurt to swallow. she originally thought she was sleeping on her pillow wrong. However, the soreness is worse, feels like a burning sensation on the right side of her neck. The dry cough does make this worse and her neck is tender to the touch and movement. Advil and heat does help the pain through out the day. The patient visited to clinic. The patient underwent laboratory test on 07Apr2021 nasal swab which resulted as negative, temperature 102.3, on unspecified date Apr 2021 temperature as 100-101?. The oucome of event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1823525
Sex: F
Age:
State: NJ

Vax Date: 08/12/2021
Onset Date: 08/15/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FC3180) via an unspecified route of administration, administered in arm left on 12Aug2021 18:30 (at the age of 61-year-old) at dose 1, single for covid-19 immunisation. Medical history included lichen planus. Patient had no known allergies. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for covid post vaccination. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) received in two weeks. On 15Aug2021 16:00 the patient experienced adverse event: Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness. Patient had no treatment for the adverse events. Outcome of the events was unknown. Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]

Current Illness:

ID: 1823526
Sex: F
Age:
State:

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: Menstrual cycle irregular; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to gluten(celiac). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced menstrual cycle irregular. The event did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the event. On an unknown date, the patient underwent COVID-19 virus test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event menstrual cycle irregular was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1823527
Sex: F
Age:
State:

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizzy; Brain fog; Diarrhea; stomach cramping; Menstrual spotting; Cramps 2 weeks early; Body aches muscles and joints; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 14Aug2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 at 19:00, the patient experienced dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1823528
Sex: F
Age:
State: NM

Vax Date: 08/02/2021
Onset Date: 08/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: red bump on her right arm which is between her wrist and elbow/red bump; red mark around her vaccination point that is "not like the bumps"; a little red bump where the inoculation was; red bump right arm, between wrist and elbow looked like an "insect bite"; it was warm to the touch; a bump to develop on right jaw and on her back; Had a red mark on vaccination site which was on left arm; it was itchy that is how she noticed it on her back; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A 86-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FA7485) via an unspecified route of administration, administered in Arm Left on 02Aug2021 (at the age of 86-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that Patient Medical History (including any illness at time of vaccination) was none; she doesn't have diabetes but she probably eats too much sugar. She also noticed if she eats too many nuts, she kind of gets bumps on her elbows, but this is self-diagnosed. She just does not eat nuts. If she does not eat nuts, it doesn't happen. However, she has never had allergies such as a rash or anything. Patient previously took flu vaccine and experienced very sore arm. She always gets it in her left arm because she is right-handed. She clarifies she didn't have the flu vaccine last year. She believes she got it at the hospital because the next year she didn't take it. The year after, she took it at pharmacy and didn't have any reaction whatsoever to it. She was told they must have hit a nerve previously, she doesn't know what happened. She has no authentic reason for why that happened. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that she has not felt ill. She doesn't have a fever, she doesn't feel nauseas. She feels fine except for the bumps. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. It was reported that on 02Aug2021, 1st week she felt fine, the following Monday 09Aug2021, she noticed a red bump on her right arm, between wrist and elbow looked like an insect bite, then it was warm to the touch. 2nd bumps went to the left arm and then later went just below her jaw above her neck and she noticed a bump on her chin, just below her lip and the last she noticed was on her back. The reporter stated that last night it was itchy that is how she noticed it on her back, it was itchy, Her husband looked at it and said it was a red bump. It was reporter that patient received the vaccine in her left arm. She explained her arms that aren't like the original one, not itching as much, the new ones are itching, the ones on her face and lip are not itching at all. The one underneath she can feel it is not as bad as on her arms, but she can feel it is there. It was reported that she had a red mark on vaccination site which was on left arm, unlike other bumps and has now completely resolved. It was reported that She has no bumps on her legs, thighs, trunk of her body- there is nothing there. It was reported that it was 09Aug2021, she had been doing some gardening and weeding and she saw this bump on her arm. She thought it feels and looks like an insect bite. She has had a spider bite before and it almost looked like a spider bite. She did not see any insects or anything and where she lives is very dry and they do not really have creepy, crawly insects. Relevant Tests reported as none. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1823529
Sex: F
Age:
State:

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Rash; Itching; Hives (On legs, arms, chest and side); This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 17Aug2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced rash, itching, and hives on legs, arms, chest, and side. The clinical outcome of the events rash, itching, and hives on legs, arms, chest, and side was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1823530
Sex: M
Age:
State: TX

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

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

Lab Data: Test Name: BCR/ABL; Test Result: Positive ; Comments: BCR/ABL-positive, not having achieved remission

Allergies:

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

Symptoms: Fatigue; Sick with headaches; very sick with headaches, fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included chronic myeloid leukaemia from an unknown date and unknown if ongoing. Concomitant medications included bosutinib (BOSULIF), loperamide hydrochloride (IMODIUM A-D), verapamil hcl (VERAPAMIL HCL ER), buspirone hcl and famotidine (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient previously took bcr-abl tyrosine kinase inhibitors. It was reported that the patient and wife were both had the covid vaccine recently and were very sick with headaches and fatigue on an unspecified date in 2021. The patient underwent lab tests and procedures which included chromosome positive (BCR/ABL-positive, not having achieved remission) on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101078366 same reporter/SD/AE, different patient

Other Meds: BOSULIF; IMODIUM A-D; VERAPAMIL HCL ER; BUSPIRONE HCL; PEPCID

Current Illness:

ID: 1823531
Sex: F
Age:
State: AZ

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Bone pain; Pain in reproductive organs (uterus); Pain in reproductive organs (ovaries); Pain in reproductive organs (lower abdomen); Abdominal cramping; Headache starting the evening of the second vaccine to current date of this report 8/19/2021, still unresolved.; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an intramuscular route of administration in the left arm on 09Aug2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an intramuscular route of administration in the left arm on an unknown date in Jul2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 09Aug2021 at 20:00, bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping and headache starting the evening of the second vaccine to current date of this report 19Aug2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping were resolved with sequelae on an unknown date in Aug2021; while that of the event headache was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1823532
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: Severe muscle spasms on the left side, arm, thigh and calf the next day; Severe SI joint, hip joint and knee joint for 2 days after the vaccine.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 08Aug2021, the patient experienced severe muscle spasms on the left side, arm, thigh and calf the next day and severe sacroiliac (SI) joint, hip joint and knee joint for 2 days after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle spasms on the left side, arm, thigh and calf was resolved with sequelae on an unknown date in Aug2021; while of the event severe SI joint, hip joint and knee joint was resolved with sequelae on 10 Aug2021, after the duration of 2 days. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1823533
Sex: F
Age:
State: TN

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: covid test; Result Unstructured Data: Test Result:did not have covid

Allergies:

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

Symptoms: had got sick; had a knot in my arm that I got the injection in/knot in left arm was reported as worsened; If she touches it, it hurts; The knot was hot and if she touched it, it hurt; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: FC3183), via an unspecified route of administration, in arm left on 20Aug2021 at 12:30 as dose 1, single (age at vaccination 57 years) for covid-19 immunisation. Medical history was diabetic, diagnosed about 8 months ago and ongoing and had bad sinuses since an unknown date and she kept an epi pen, she took covid test and did not have covid, this was prior to the vaccine. The history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's concomitant medications were not reported. She got her first dose on 20Aug2021, Friday, and the following day she had a knot in her arm that she got the injection in and it had gotten worse on 21Aug2021. The knot was hot and if she touched it, it hurt in 2021. Someone said put some pressure on it but she was scared to do that. She was asking if her left arm was supposed to feel like a knot. She started feeling the knot on Saturday and it started getting bigger and bigger. People told her she may have a blood clot and they were driving her nuts. She reported she had got sick and thought she had it and it was instead an upper sinus infection. The patient did not take any therapeutic treatment for the events. The patient underwent lab tests which included sars-cov-2 test: did not have covid on an unknown date and this was prior to the vaccine. There were no relevant tests. No additional vaccines were administered on same date as that of the pfizer suspect. The events did not require a visit to emergency room or the physician office. There were no prior vaccinations (within 4 weeks). There were no adverse events following prior vaccinations. The patients relevant family medical history was none. The outcome of the event had a knot in my arm that i got the injection in was not recovered and rest of all event outcome was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Diabetic (diagnosed about 8 months ago)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am