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: 1718138
Sex: U
Age:
State: TX

Vax Date: 08/26/2021
Onset Date:
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Date refrigerated: 20 Apr 2021 Temperature changes (in F): 42

Other Meds:

Current Illness:

ID: 1718139
Sex: U
Age:
State: TX

Vax Date: 08/22/2021
Onset Date:
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) to be not applicable. No Concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718140
Sex: M
Age: 62
State: MA

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 09/21/2021
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: felt a slight heavy feeling in that arm.; After the first dose he experienced a slight pain in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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 12-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm). On 14-Mar-2021, VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Antibiotics Treatment information included Windmill exercises This case was linked to MOD-2021-315705 (Patient Link).

Other Meds:

Current Illness:

ID: 1718141
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Long QT syndrome; This spontaneous case was reported by a consumer and describes the occurrence of LONG QT SYNDROME (Long QT syndrome) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LONG QT SYNDROME (Long QT syndrome). At the time of the report, LONG QT SYNDROME (Long QT syndrome) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment drug information provided. No concomitant drug information provided. Company comment- This case concerns an unknown age male subject with unknown relevant medical history, who experienced the unexpected event of LONG QT SYNDROME. The event occurred on an unknown date and there are no vaccination dates available. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Despite the event Long QT syndrome being automatically upgraded to serious as per IME list it was manually overridden according to provided narrative and medical judgement. Additional query was sent to obtain missing information and clarify details regarding this event.; Sender's Comments: This case concerns an unknown age male subject with unknown relevant medical history, who experienced the unexpected event of LONG QT SYNDROME. The event occurred on an unknown date and there are no vaccination dates available. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Despite the event Long QT syndrome being automatically upgraded to serious as per IME list it was manually overridden according to provided narrative and medical judgement. Additional query was sent to obtain missing information and clarify details regarding this event.

Other Meds:

Current Illness:

ID: 1718142
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: got firm sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got firm sickness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Wasp sting on 21-Aug-2021 and Sickness (stung by a wasp then week after that the wasp site also got firm sickness.). 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 ILLNESS (got firm sickness). At the time of the report, ILLNESS (got firm sickness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. the concomitant medications and treatment information's ware not provided.

Other Meds:

Current Illness:

ID: 1718143
Sex: M
Age: 19
State: IA

Vax Date: 09/03/2021
Onset Date: 09/07/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tiredness; headaches; having a lot of fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (having a lot of fever), HEADACHE (headaches) and FATIGUE (tiredness) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (having a lot of fever), HEADACHE (headaches) and FATIGUE (tiredness). On 08-Sep-2021, PYREXIA (having a lot of fever), HEADACHE (headaches) and FATIGUE (tiredness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1718144
Sex: F
Age: 54
State: TN

Vax Date: 08/12/2021
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Arm has swollen up as big as a softball/swell up; Extremely hot; Big bruise; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise). At the time of the report, PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718145
Sex: U
Age:
State: SC

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Invalid doses administered; 400 doses were refrigerated beyond 30 days and administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid doses administered) and PRODUCT STORAGE ERROR (400 doses were refrigerated beyond 30 days and administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid doses administered) and PRODUCT STORAGE ERROR (400 doses were refrigerated beyond 30 days and administered). On 19-May-2021, EXPIRED PRODUCT ADMINISTERED (Invalid doses administered) and PRODUCT STORAGE ERROR (400 doses were refrigerated beyond 30 days and administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information not provided. Treatment information not provided. Number of doses/vials 1230 doses administered but approximately 400 doses were refrigerated beyond 30 days and administered. Date the vial was initially stored in the refrigerator 13Apr2021 and administrated between 19May2021 and through June and July 2021.

Other Meds:

Current Illness:

ID: 1718146
Sex: U
Age:
State:

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 09/21/2021
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: I got the vaccine last Thursday but it's still swollen, red, and hurting; I got the vaccine last Thursday but it's still swollen, red, and hurting; I got the vaccine last Thursday but it's still swollen, red, and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting) 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 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting). At the time of the report, VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718147
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Now have a slight headache; High fever; Vomitting; Joint pain; So bad I could not walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (So bad I could not walk), HEADACHE (Now have a slight headache), PYREXIA (High fever), VOMITING (Vomitting) and ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 GAIT INABILITY (So bad I could not walk), HEADACHE (Now have a slight headache), PYREXIA (High fever), VOMITING (Vomitting) and ARTHRALGIA (Joint pain). At the time of the report, GAIT INABILITY (So bad I could not walk), PYREXIA (High fever), VOMITING (Vomitting) and ARTHRALGIA (Joint pain) had resolved and HEADACHE (Now have a slight headache) outcome was unknown. Patient reported the events after receiving the second dose of Moderna vaccine the side effects were intense. No concomitant medication details was provided. No treatment medication details was provided.

Other Meds:

Current Illness:

ID: 1718148
Sex: F
Age:
State: NV

Vax Date: 09/09/2021
Onset Date:
Rec V Date: 09/21/2021
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: Administration of expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) 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 Vaccine was administered on 09Sep2021 patient's second dose. HCP said patient was not experiencing any symptoms, patient left fine with no issues. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Non sig fup: We have already completed a VAERS report for this incident. The temporary number is 640223.

Other Meds:

Current Illness:

ID: 1718149
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-317635, MOD-2021-317617 (Patient Link).

Other Meds:

Current Illness:

ID: 1718150
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Severe fatigue). At the time of the report, FATIGUE (Severe fatigue) outcome was unknown. No concomitant medication were reported. No treatment information was provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718151
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: something bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (something bad) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (something bad). At the time of the report, FEELING ABNORMAL (something bad) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information were provided. No treatment information were provided

Other Meds:

Current Illness:

ID: 1718152
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date: 09/12/2021
Rec V Date: 09/21/2021
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: 20210912; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: had vaccine January and February, tested positive for covid; Diagnosed positive covid-19 yesterday; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed positive covid-19 yesterday) and DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced COVID-19 (Diagnosed positive covid-19 yesterday). On an unknown date, the patient experienced DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid). At the time of the report, COVID-19 (Diagnosed positive covid-19 yesterday) outcome was unknown and DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. Concomitant medication was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718153
Sex: M
Age: 57
State: MO

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/21/2021
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: Loss of smell; Cough; Difficult to talk; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk). At the time of the report, ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk) outcome was unknown. Doctor stated that the these symptoms recur every month. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1718154
Sex: F
Age: 0
State:

Vax Date: 09/09/2021
Onset Date:
Rec V Date: 09/21/2021
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: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: so sick now; developed a thrush inf; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf) 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 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf). At the time of the report, ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative. No concomitant medication reported. No treatment medication reported. This case was linked to MOD-2021-317625 (Patient Link).

Other Meds:

Current Illness:

ID: 1718155
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/21/2021
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: week of feeling sick; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting) 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. In September 2021, the patient experienced MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications or treatment details were reported.

Other Meds:

Current Illness:

ID: 1718156
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: chest pain; Chest tenderness; feeling of fluttering In Chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest). At the time of the report, CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications or treatment details were reported.

Other Meds:

Current Illness:

ID: 1718157
Sex: F
Age: 55
State: AZ

Vax Date: 12/29/2020
Onset Date: 09/07/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Date: 20210907; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: High; Test Date: 20210904; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210907; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Kidney stone; Lack of drug effect; Covid 19 antibody test was positive /She currently feels very weak, sick, kind of like out of breath/ she can't really smell anything /coughing; This spontaneous case was reported by an other health care professional and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 026520-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Covid 19 antibody test was positive /She currently feels very weak, sick, kind of like out of breath/ she can't really smell anything /coughing). On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (Kidney stone), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Covid 19 antibody test was positive /She currently feels very weak, sick, kind of like out of breath/ she can't really smell anything /coughing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. On 07-Sep-2021, SARS-CoV-2 antibody test: 4.05 (High) High. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. The patient has received 2 doses of the Moderna covid-19 vaccine by intramuscular injection on 29DEC2020 (lot number 026520-2A, expiration date unknown), and 26JAN2021 (lot number 043L20A, expiration date unknown). She has been fine throughout most the pandemic. She went to the hospital on 23AUG2021 for a lithotripsy for a kidney stone. This was an outpatient procedure and she felt like she never recovered. She was staying at her daughter's house after the procedure. 1 week later, on 31AUG2021, her son in lawand 9 months pregnant daughter, both in their 30s, tested positive for covid-19. Because she continued to not feel right, like she had a little bit of a cold, she was tested for covid-19 on 4SEP2021 which was negative. She went for another swab and antibody test on 7SEP2021 which was positive and the antibody test showed a result of 4.05. She currently feels very weak, sick, kind of like out of breath, and like she basically can't do anything. She has been a little nauseous, finds it very hard to eat something, she can't really smell anything and everything tastes like dust or something. She also feels very dizzy, weak, disoriented, and like she was on another planet. Last night she started coughing a lot, with a dry cough that won't stop once you start coughing. She has been taking Tylenol for her symptoms. She has also talked to her nephrologist who said the shot probably saved her life. Company Comment: This case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected events of nephrolithiasis and COVID 19. Additional event of drug ineffective was also considered. The events occurred approximately 7 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected events of nephrolithiasis and COVID 19. Additional event of drug ineffective was also considered. The events occurred approximately 7 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1718158
Sex: F
Age: 70
State: OR

Vax Date: 03/14/2021
Onset Date:
Rec V Date: 09/21/2021
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: with no energy; was just tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was just tired) and ASTHENIA (with no energy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A; and 071A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal and Depression. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FATIGUE (was just tired) and ASTHENIA (with no energy). At the time of the report, FATIGUE (was just tired) and ASTHENIA (with no energy) outcome was unknown. Concomitant medications included unspecified antidepressant and blood pressure medication. No treatment information was reported. This case was linked to MOD-2021-047855 (Patient Link).

Other Meds:

Current Illness: Blood pressure abnormal; Depression

ID: 1718159
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1718160
Sex: M
Age: 70
State: FL

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 09/21/2021
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: Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-318263, MOD-2021-318424 (Patient Link).

Other Meds:

Current Illness: Blood pressure high

ID: 1718161
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: it's feeling the mucus on his system; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (it's feeling the mucus on his system) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SECRETION DISCHARGE (it's feeling the mucus on his system). At the time of the report, SECRETION DISCHARGE (it's feeling the mucus on his system) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. No treatment medications provided.

Other Meds:

Current Illness:

ID: 1718162
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: joint pain; all over aches snd pains in my muscles; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and MYALGIA (all over aches snd pains in my muscles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (all over aches snd pains in my muscles). At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (all over aches snd pains in my muscles) outcome was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718163
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: coughing; head has been plugged up; nose and sinuses really; cannot lay down; slept three nights sitten up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up) in a 0-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04813218) for COVID-19 vaccination. Concomitant products included AMLODIPINE, ATORVASTATIN and OXYCODONE for an unknown indication. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up). At the time of the report, COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other concomitant medication included Prostate medication and Androgens. Treatment medication use was not provided by the reporter. Caller got tested for COVID. Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Follow-up contains no new information.

Other Meds: AMLODIPINE; ATORVASTATIN; OXYCODONE

Current Illness:

ID: 1718164
Sex: U
Age:
State: IL

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: 2 patients administered dose out of a vial that was in the fridge for 31 days; 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 (2 patients administered dose out of a vial that was in the fridge for 31 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients administered dose out of a vial that was in the fridge for 31 days). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2 patients administered dose out of a vial that was in the fridge for 31 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information provided by the reporter No treatment information provided by the reporter It was reported that Pharmacist did not know if it was consumer's 1st or second dose .2 doses administered out of a vial that was in the adverse events fridge for 31 days.

Other Meds:

Current Illness:

ID: 1718165
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

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

Other Meds:

Current Illness:

ID: 1718166
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Is it normal to have a reaction a week after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine). At the time of the report, VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718167
Sex: F
Age: 74
State: FL

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Little discomfort; Body aches; Injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm was warm), DISCOMFORT (Little discomfort) and MYALGIA (Body aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The patient's past medical history included Thyroid operation (Thyroid removed). Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm was warm). On 05-Feb-2021, the patient experienced DISCOMFORT (Little discomfort) and MYALGIA (Body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of Every 4 hours. At the time of the report, VACCINATION SITE WARMTH (Injection arm was warm), DISCOMFORT (Little discomfort) and MYALGIA (Body aches) outcome was unknown. Treatment details include ice. This case was linked to MOD-2021-318648, MOD-2021-318659 (Patient Link).

Other Meds: INSULIN; FOLIC ACID; CALCIUM; MELOXICAM

Current Illness: Diabetes

Date Died: 02/09/2021

ID: 1718168
Sex: M
Age: 62
State: OH

Vax Date: 01/13/2021
Onset Date: 02/08/2021
Rec V Date: 09/21/2021
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: 20210208; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: Fever progressed to 103F; Test Date: 20210208; Test Name: oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: At 10pm his oxygen level dropped

Allergies:

Symptom List: Injection site pain

Symptoms: Patient passed away February 9, 2021 at 2:12am.; At around 11:30pm-11:45pm difficulty of breathing was noted.; fever,Fever progressed to 103F; Very tired/feeling of very tired; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient passed away February 9, 2021 at 2:12am.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L-20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced DYSPNOEA (At around 11:30pm-11:45pm difficulty of breathing was noted.), PYREXIA (fever,Fever progressed to 103F) and FATIGUE (Very tired/feeling of very tired). The patient was treated with PARACETAMOL (TYLENOL) on 08-Feb-2021 for Fever, at a dose of 1 dosage form. On 09-Feb-2021, DYSPNOEA (At around 11:30pm-11:45pm difficulty of breathing was noted.), PYREXIA (fever,Fever progressed to 103F) and FATIGUE (Very tired/feeling of very tired) outcome was unknown. The patient died on 09-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 103 (Inconclusive) Fever progressed to 103F. On 08-Feb-2021, Oxygen saturation: decreased (Inconclusive) At 10pm his oxygen level dropped. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication also included medication for blood pressure. On 08 Feb 2021 patient had the 2nd dose of Moderna Covid19 vaccine in the morning. Patient was fine until 5pm when patient complained of fever and feeling of very tired. Fever progressed to 103F. Patient took Tylenol. At 10pm his oxygen level dropped; patient laid down in bed. At around 11:30pm-11:45pm difficulty of breathing was noted. They immediately called 911. 911 came at around 12:50am but the patient arrested in the driveway. At the Emergency Room, they tried to revive the patient but unsuccessful. Patient passed away on 09 Feb 2021 at 2:12am. This case concerns a 62 year old male experienced serious adverse event of death one day after receiving the second dose of the vaccine and in addition with non-serious adverse events of dyspnea, fever and fatigue. Dechallenge was unknown and rechallenge was not applicable. Limited information provided. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 62 year old male experienced serious adverse event of death one day after receiving the second dose of the vaccine and in addition with non-serious adverse events of dyspnea, fever and fatigue. Dechallenge was unknown and rechallenge was not applicable. Limited information provided. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Unknown Cause of death

Other Meds: XARELTO

Current Illness:

ID: 1718169
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; fatigue; felt a feverish sensation; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Sanofi Pasteur quadrivalent influenza vaccine (Sanofi Pasteur quadrivalent influenza vaccine) in 2017. Past adverse reactions to the above products included Adverse event with Sanofi Pasteur quadrivalent influenza vaccine. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation). At the time of the report, MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. My allergist/immunologist and cardiologist were very pleased my COVID vaccinations went so well. Patient was having hereditary alpha tryptasemia genetic trait, confirmed by a Gene-by-Gene genetic test. Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received includes Added reporter details (Non-significant information).

Other Meds:

Current Illness:

ID: 1718170
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: I got COVID after the first; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID after the first) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got COVID after the first). At the time of the report, COVID-19 (I got COVID after the first) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1718171
Sex: F
Age:
State: TX

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) 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 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient is in another country and hence could not take her second dose. She was asked to take the second dose of Pfizer vaccine on 14-SEP-2021 and she has to start over. Concomitant medications were not provide No treatment medications were provided

Other Meds:

Current Illness:

ID: 1718172
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/13/2021
Rec V Date: 09/21/2021
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: My right arm has been numb; My right arm has been causing pain and discomfort; My right arm has been causing pain and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort). At the time of the report, HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort) outcome was unknown. No concomitant medication details was provided. No treatment medication details was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718173
Sex: F
Age: 26
State: AR

Vax Date: 08/13/2021
Onset Date: 08/01/2021
Rec V Date: 09/21/2021
Hospital: Y

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: Hallucinations; Psychological problems/unable to speak for herself; Memory problems/getting lost; Delusions; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), MENTAL DISORDER (Psychological problems/unable to speak for herself), MEMORY IMPAIRMENT (Memory problems/getting lost) and DELUSION (Delusions) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Embolic shower (similar to stroke) in 2012 and Accident (Car accident) in 2012. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criteria hospitalization and medically significant), MENTAL DISORDER (Psychological problems/unable to speak for herself) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Memory problems/getting lost) (seriousness criterion hospitalization) and DELUSION (Delusions) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to DELUSION, HALLUCINATION, MEMORY IMPAIRMENT and MENTAL DISORDER. At the time of the report, HALLUCINATION (Hallucinations), MENTAL DISORDER (Psychological problems/unable to speak for herself), MEMORY IMPAIRMENT (Memory problems/getting lost) and DELUSION (Delusions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient's parent reported that patient has been in the hospital for 10 days. Patient was unable to speak for herself after receiving the vaccination. Patient experienced psychological problems within a week after vaccination, which turned out to delusions, hallucinations. Doctors were trying to understand the reactions. Company Comment: This case concerns a 26 year-old, female subject with a history of Embolic Shower, who experienced the unexpected events of Hallucinations and Mental Disorder. The event occurred approximately unknown date, after the first dose of Moderna Covid-19 vaccine. The medical history, Embolic shower and use of concomitant medication Duloxetine remains a confounder. The benefit-risk relationship of mRNA-1273, is not affected by this report.; Sender's Comments: This case concerns a 26 year-old, female subject with a history of Embolic Shower, who experienced the unexpected events of Hallucinations and Mental Disorder. The event occurred approximately unknown date, after the first dose of Moderna Covid-19 vaccine. The medical history, Embolic shower and use of concomitant medication Duloxetine remains a confounder. The benefit-risk relationship of mRNA-1273, is not affected by this report.

Other Meds: CYMBALTA

Current Illness:

ID: 1718174
Sex: F
Age: 68
State: VA

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/21/2021
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: pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 006M20A) for COVID-19 vaccination. No medical history was provided by the reporte. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her left arm). At the time of the report, PAIN IN EXTREMITY (pain in her left arm) outcome was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1718175
Sex: F
Age: 66
State: WA

Vax Date: 01/03/2021
Onset Date: 03/01/2021
Rec V Date: 09/21/2021
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: Inappropriate schedule of vaccine administered; itch; blisters; redness; pain; rash generally came up on leg and face / Skin behind rear covered in rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MIRTAZAPINE, CITALOPRAM, OMEPRAZOLE and SIMVASTATIN for an unknown indication. On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. No treatment information was provided

Other Meds: MIRTAZAPINE; CITALOPRAM; OMEPRAZOLE; SIMVASTATIN

Current Illness:

ID: 1718176
Sex: M
Age:
State: NY

Vax Date: 04/23/2021
Onset Date: 05/06/2021
Rec V Date: 09/21/2021
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: Second dose less than 25 days after the first; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first) 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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first). On 06-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first) had resolved. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718177
Sex: F
Age: 35
State: CA

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/21/2021
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: injection site pain; puffy face; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 017E21A) 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) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face). At the time of the report, INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-319707 (Patient Link).

Other Meds:

Current Illness:

ID: 1718178
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: 14 years old son got the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years old son got the first dose) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years old son got the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years old son got the first dose) had resolved. The pediatrician called and apologized for the administration error since the patient's son was not eligible to get the vaccine. No concomitant medication reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718179
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital: Y

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: discovered a tumor in left side of the brain; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN NEOPLASM (discovered a tumor in left side of the brain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN NEOPLASM (discovered a tumor in left side of the brain) (seriousness criteria hospitalization and medically significant). At the time of the report, BRAIN NEOPLASM (discovered a tumor in left side of the brain) outcome was unknown. No concomitant medication details were provided. No treatment medication details were provided. Reporter advised patient was now in ICU and that patient that he was probably in his 50s. This case concerns a male patient with no relevant medical history reported, who experienced the unexpected event of brain neoplasm. The events occurred after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient with no relevant medical history reported, who experienced the unexpected event of brain neoplasm. The events occurred after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1718180
Sex: U
Age:
State: IL

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 09/21/2021
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 Date: 20210414; Test Name: Covid 19; Test Result: Negative ; Comments: Headach, Sore throat,stomach. Employer set me for test; Test Date: 20210731; Test Name: Covid 19; Test Result: Negative ; Comments: Around parent of Kid who test positive

Allergies:

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

Symptoms: Headache; Thirst; Sore Arm; I had the J&J vaccine in Mar2021; On 28May I had the first Pfizer dose. On 22Jul I have just received my second dose of Pfizer; I had the Johnson and Johnson vaccine in Mar2021; On 28May I had the first Pfizer dose. On 22Jul I have just received my second dose of Pfizer; I had the J&J vaccine in Mar2021; On 28May I had the first Pfizer dose. On 22Jul I have just received my second dose of Pfizer; This is a spontaneous report from a contactable consumer (patient) from Pfizer forwarded as an Adverse Event on 23Jul2021. A 52-years-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number EW0179, expiration date: Aug2021), via intramuscular route of administration, administered in left arm on 28May2021 (After 12PM) (at the age of 52-years-old) as dose 2, initial Pfizer dose, single and (Lot number FA6780), via intramuscular route of administration, administered in left arm on 22Jul2021 (After 12 PM) as dose 3, single for covid-19 immunisation. Medical history included asthma from 1980 to ongoing, anxiety from 2018 to ongoing. Family history included high blood pressure (father), Type 2 diabetics (mother) and hypertension (mother). Prior to vaccinations, no medication received within 4 weeks. Concomitant medications included escitalopram oxalate (LEXAPRO) for anxiety, albuteral for asthma, cetirizine hydrochloride (ZYRTEC) for asthma and allergies and multivitamin (MANUFACTURER UNKNOWN), all from an unspecified date and ongoing, ibuprofen (MANUFACTURER UNKNOWN) to ease pain, from an unspecified date and unknown if ongoing. Patient took historical vaccine Janssen covid-19 vaccine (J&J, Lot number 1805025) via an unspecified route of administration from 05Mar2021 at dose 1, single for covid-19 immunisation. It was reported that the patient had the J&J vaccine in 05Mar2021. Patient family members all had Pfizer. Patient did not want to take a chance that, would bring home a strain to patient kids because J and J covers a different variant. On 28May2021 the patient had the first Pfizer dose. On 22Jul2021 the patient has just received the second dose of Pfizer; on an unknown date. On 13Sep2021, it was reported that, patient had sore arm, thirst on 23Jul2021 and headache on 24Jul2021. The patient underwent laboratory data and procedures which included Covid 19 with result negative (Headache, Sore throat, stomach. Employer set me for test) on 14Apr2021 and negative (Around parent of Kid who tested positive) on 31Jul2021. The outcome of events sore arm, thirst and headache was unknown. Information on the lot/batch number has been requested. Follow-up (09Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Follow-up (13Sep2021): New information received from a contactable consumer. This consumer reported in response to non-HCP letter sent that included: medical history, suspect information (lot number, expiry date, route, anatomical location), new events (sore arm, thirst and headache), new concomitant (escitalopram oxalate (LEXAPRO), Albuteral, cetirizine hydrochloride (ZYRTEC), ibuprofen and multivitamin), laboratory data. Follow-up attempts are completed. No further information is expected.

Other Meds: LEXAPRO; IBUPROFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness: Anxiety; Asthma

ID: 1718181
Sex: F
Age:
State: MD

Vax Date: 07/17/2021
Onset Date: 07/26/2021
Rec V Date: 09/21/2021
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: coughing; Her ribs are still a little sore today; This is a spontaneous report from a contactable Consumer (patient herself). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation (Age at Vaccination was 69 years). The patient's medical history included diabetes, High blood pressure, Hiatal hernia, vertigo, COPD, hypertension, cardiac and asthma (family history). Concomitant medications included Insulin and Aspirin (Acetylsalicylic acid) taken for cardiac disorder. It was stated that, prior vaccinations (within 4 weeks) were she doubts that seriously but, can't say for sure. On 26Jul2021, it was reported that, the patient experienced she was been into have little bit of coughing, she was having some coughing and her ribs are still a little sore today. No therapeutic measures were taken as a result of events. She did not visit Emergency Room or Physician Office for the events. The seriousness of the events was considered as non-serious. The outcome of the event coughing was unknown and for her ribs are still a little sore today was not recovered. Follow-up attempts have been completed and no further information is expected. Lot/batch number cannot be obtained.

Other Meds: INSULIN; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1718182
Sex: F
Age:
State: GA

Vax Date: 07/29/2021
Onset Date: 08/02/2021
Rec V Date: 09/21/2021
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: Rash beginning at injection site; slightly swollen; red; itchy; slightly sore; Left side of tongue and under the left side of tongue feel like they've been injected with novocaine; left side of neck feels slightly numb; going down about 6 inches on the arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: F87484), via an unspecified route of administration, administered in Arm Left on 29Jul2021 17:00 (at the age of 59 years old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included High Blood Pressure from an unknown date and unknown if ongoing, Acid Reflux (gastrooesophageal reflux) disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, Thyroid Nodules (thyroid mass) from an unknown date and unknown if ongoing. Concomitant medication(s) included VIT C (Ascorbic Acid); VIT. E (Tocopherol); Vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took percocet [oxycodone hydrochloride;paracetamol], cefdinir, Enbrel and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA6780), via an unspecified route of administration on 08Jul2021 12:00 administered in left arm as single dose for. The patient was not pregnant at the time of vaccination. It was reported that covid prior to vaccination was No. It was reported that covid tested post vaccination was No. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient experienced rash beginning at injection site, slightly swollen, red, itchy, slightly sore, left side of tongue and under the left side of tongue feel like they've been injected with novocaine, left side of neck feels slightly numb, going down about 6 inches on the arm on 02Aug2021 08:00. No trouble swallowing but feels funny. Therapeutic measures were taken as no as a result of all events. The outcome of events was unknown.

Other Meds: VIT C; VIT. E; VITAMIN D3

Current Illness:

ID: 1718183
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/02/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Comments: Result work ok; Test Name: EKG; Result Unstructured Data: Test Result:Unknown result; Test Name: Heart rate abnormal; Result Unstructured Data: Test Result:abnormal

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: pounding in my heart; I have like trembling in my legs and then a radiation going through my body; I feel like there is some anxiety; I am having a hard time going to sleep; Mucus spilting up mucus 30 minutes after injection; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced pounding in heart, had like trembling in legs and then a radiation going through body (ICE cold), feel like there was some anxiety, having a hard time going to sleep and mucus spilting up mucus 30 minutes after injection. It was reported that, the patient tried to lay down but was experiencing it is like pounding and she had like trembling in her legs and then a radiation went through her body and she also took some Calcium Magnesium, so she did not know if that was supposed to calm her, calm her down but she felt like there was some trembling going on her legs. The patient wanted to report that she was looping a pounding in her heart and she was having a hard time going to sleep. She feels like there was some anxiety. She reported she was going to call the advisor she was in the stress right now and she was not getting anywhere. She went to the ER and then administered 25mg antihistamine (Benadryl) on 03Aug2021. They ran an EKG and blood work full panel. Results were ok and she was sent home. Her symptoms samed all elevated after 30 minutes of taking Benadryl. She was fine the following day. The patient took Benadryl and antihistamines for Anxiety-legs, trembling-mucus. The patient was not taking any other products together with those Benadryl. Admission to hospital due to the event was reported as no. The patient underwent lab tests and procedures which included blood work: unknown result (Result work ok), EKG: unknown result, heart rate abnormal: abnormal, on an unspecified date. Therapeutic measures were taken as a result of events. At the time of report the patient was not taking any medication. The outcome of the events pounding in my heart and I feel like there is some anxiety was reported as not recovered. The outcome of the events I have like trembling in my legs and then a radiation going through my body and I am having a hard time going to sleep was reported as recovered. The outcome of the event mucus spilting up mucus 30 minutes after injection was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1718184
Sex: F
Age:
State: OH

Vax Date: 07/16/2021
Onset Date: 07/01/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: developed pain on her left arm just above the elbow going to the mid part of her chest; developed pain on her left arm just above the elbow going to the mid part of her chest; developed pain on her left arm just above the elbow going to the mid part of her chest; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Jul2021 (age at vaccination 50 years) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration, on 22Jun2021 (age at vaccination 50 years) as dose 1, single for COVID-19 immunization. On an unknown date in Jul2021, patient developed pain on her left arm where she had the shot just above the elbow going to the mid part of her chest. It was reported that she had her second Covid vaccine on 16Jul2021 and since then has had pain from her left arm where she had the shot to the middle of her chest. Stated that she thought that it would ease up and it has not. Stated that it was concerning her. Wanted to know if someone reported this before and if this was something that she should go to the hospital about. The patient had not yet recovered from the events. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1718185
Sex: F
Age:
State: VT

Vax Date: 03/19/2021
Onset Date: 03/23/2021
Rec V Date: 09/21/2021
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: loud tinnitus; vertigo; An increase in frequency of and intensity of migraines; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 56-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EN6204) via an unspecified route of administration in right arm on 19Mar2021 13:00 as dose 1, single (at the age of 56-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included migraines, seizure disorder, three years of out breast cancer, high blood pressure. Patient known allergies included allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced very loud tinnitus in right ear, self spinning vertigo and an increase in frequency of and intensity of migraines on 23Mar2021. The adverse events resulted in a visit to Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of loud tinnitus, vertigo, migraines. The outcome of the event was not recovered. No Follow-up attempts are possible. Information about lot/batch number cannot be obtained. Follow-up attempts have been completed and No further information is expected.

Other Meds:

Current Illness:

ID: 1718186
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: by the time she got her 2nd shot it was like 6 weeks or more after the 1st one; chills; diarrhea; headache; joint pain; fever; sweating; it was like I was drained of all my energy; the site where I got injected was swollen, red, and hurt for a long time; the site where I got injected was swollen, red, and hurt for a long time; had to wear air all the time; she got the shot and then she got extremely ill for a long time, over a month; loss her sense of smell; didn't eat; lethargic; This is a spontaneous report from a contactable consumer or other other non-health care professional (patient herself) . A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot: Not Provided), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included was sick in between the two doses. There were no concomitant medications. Patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot: Not Provided), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient reported that she received her second Pfizer covid 19 dose after it had been left out for "a couple of days". According to the patient, the nurse at the clinic did not want to administer the dose and "the doctor said just get it". Patient asked "what does Pfizer recommend, for storage of the vaccine at room temperature? Is it suppose to be refrigerated?". Patient received her first Pfizer covid 19 vaccine, was sick in between the two doses, received her second dose of the vaccine six weeks or more after the first dose. The nurse at her doctor's office told the doctor the doses aren't good because they were out for too long, the nurse didn't want to give it out. Patient said her doctor said just get it. She said the vaccines were left out for a couple of days. The patient experienced chills, diarrhea, headache, joint pain, fever, sweating hot, patient said, "it was like I was drained of all my energy", "the site where I got injected was swollen, red, and hurt for a long time", and "had to wear air all the time", loss her sense of smell, didn't eat, and "had to drink Gatorade by the gallons because I was lethargic". This consumer (patient) reported that, by the time she got her 2nd shot it was like 6 weeks or more after the 1st one. Nurse told the doctor that the shots weren't any good as they had been sitting out for some time and the doctor says they are fine get it anyway and she got the shot. She got the shot and then she got extremely ill for a long time, over a month. Patient stated she got her 1st shot no problem but in between, she was supposed to go back in 3 weeks and she got sick so she couldn't make it to her next appointment for her shot. She got her 1st shot no problem but in between, she was supposed to go back in 3 weeks and she got sick so she couldn't make it to her next appointment for her shot. States she got the Pfizer shot. States by the time she got her 2nd shot it was like 6 weeks or more after the 1st one. Patient relays her doctor told the nurse to go get her a shot, well the nurse told the doctor that the shots weren't any good as they had been sitting out for some time and the doctor says they are fine get it anyway and she got the shot and then she got extremely ill for a long time, over a month. Patient states she still has she doesn't know, she hasn't been well for a year and a half since this whole stuff started. She states she is wondering what could happen if that shot was left out. She wants to know why she got sick like that, should she have not been given that shot since it was left out of refrigeration. Patient was asking if it is supposed to be refrigerated. Patient stated she does not know how long it was left out, just that nurse said it wasn't good and they weren't giving it out to anybody. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1718187
Sex: F
Age:
State: FL

Vax Date: 07/30/2021
Onset Date: 08/01/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a Pfizer sponsored program reported by patient. A 45-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: Not reported), via an unspecified route of administration on 30Jul2021 (at the age of 45-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arm pain on 01Aug2021, the other day she felt like her heart was racing. On 02Aug2021 she's been on the bed for 3-4 hours crying for no reason, felt like little baby ants crawling all over her skin, she would get up every 5 to 10 minutes, anxiety attack, fast heartbeat and felt tingly all over. On 03Aug2021 she could not sleep, caller also stated that her appetite "sucks" right now, she was feeling thirsty but does not want to drink anything, she had anxiety/anxiety attack. Her massive migraine headaches were horrible on 04Aug2021. On an unspecified date patient had no appetite and was exhausted. Clinical course: On the first day she got the shot, she had arm pain for 2 days and on the third day, she had anxiety and has been on the bed for 3-4 hours crying for no reason. Patient said she never had anxiety before. Then on the fourth day, she said, she could not sleep since on the fourth and fifth day, she felt like ants were crawling all over her skin and she would get up every 5 to 10 minutes. Her appetite sucks right now and that her massive migraine headaches were horrible. Patient added that today she did not have any headache, but for five days in a row she had a migraine headache. Caller also mentioned feeling thirsty but does not want to drink anything and that last night was the only time she could eat and got 2 pieces of pizza but today she does not feel like eating again. First couple days she was fine but on the 3rd day she was out of it. She had anxiety and a panic attack. She had no appetite and has been exhausted with a fast heartbeat. She was unsure if she should receive the second COVID 19 vaccine or if there was an alternative. She added that she and her husband both received the COVID-19 vaccine. She was iffy about getting the vaccine because the whole thing was very scary. Her husband got his vaccine 2 weeks ago. She did not want to get the COVID-19 vaccine because she was afraid of needles and she was already not happy about getting the COVID-19 vaccine. Her husband talked her into getting the vaccine by telling her that she would either get the COVID-19 vaccine or she would end up in the hospital or dying with the COVID -19 virus. The first 2 days after her COVID-19 vaccine she was fine. On the third day she had a really bad anxiety attack. She spent hours on her bed crying for no reason. Her husband sat with her and rubbed her hair and cried with her and told her it was going to be ok. Her husband got her off the bed to go for a walk. She was up all night long every 10 to 15 minutes. It felt like little baby ants crawling all over her skin. She felt tingly all over and she didn't sleep at all. Her appetite was horrible. She was not eating anything. Last night was the first night she was able to eat a couple slices of pizza. The events outcome was reported as unknown. Follow up attempts completed. Information about lot/batch number cannot be obtained. No further information is expected..

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am