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: 1799351
Sex: F
Age: 41
State: CA

Vax Date: 09/14/2021
Onset Date: 09/15/2021
Rec V Date: 10/19/2021
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: SINCE THE SHOT THE FOLLOWING MORNING THE PATIENT STATES SHE HAS EXPERIENCED EXTREME NERVOUSNESS THAT HAS NOT COMPLETELY SUBSIDED AS OF 10/19/2021

Other Meds:

Current Illness:

ID: 1799352
Sex: F
Age: 14
State: SC

Vax Date: 10/16/2021
Onset Date: 10/18/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Medication and supportive care only

Allergies: none

Symptom List: Anxiety, Dyspnoea

Symptoms: L axillary lymph node swelling. Tongue swelling and discomfort enough to warrant ER visit

Other Meds: none

Current Illness: none

ID: 1799353
Sex: M
Age: 35
State: CA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/19/2021
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: none

Allergies: none

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

Symptoms: I got the vaccine at : around 16:15 then I went home and until like 22:30 everything was fine. Then after 10:30 I started to get fever and headache. Then I went to sleep I think around 2AM. I was having headaches, chills, fever, and I was feeling week. I could not really sleep well. I was constantly moving from one side to another and moving my body. The next day I woke up around 9:30 and I had huge headed, my eyeballs ware hurting as well, fever and chills. Also my eardrums ware hurting me as well as the stomach a little. Honestly I was moving my body all the time I could not stay still for more then 3 minutes. My muscles ware tired. I was not really be able to sleep, probably i have not feel this bad in years. Now after like 18:30 I started to feel better and my headache is starting to fade. No issues with the eyeballs or stomach. I could not really eat anything beside drinking tea and also I was so weakened I did not move much beside staying in bed. At around 20:30 I still feel I have fever but not as bad and no headaches anymore

Other Meds: none

Current Illness: none

ID: 1799473
Sex: F
Age: 1
State: MT

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: None at this time.

Allergies: NKDA

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Abdominal pain, diarrhea. Symptoms started 30-60 minutes after receiving Dtap vaccine and lasted at least 24 hours.

Other Meds: None

Current Illness: None

ID: 1799474
Sex: F
Age: 59
State: CA

Vax Date: 08/26/2021
Onset Date: 09/01/2021
Rec V Date: 10/19/2021
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: Developed 2 hardened lymph nodes in left breast.

Other Meds: multi vitamin

Current Illness: none

ID: 1799475
Sex: F
Age: 63
State: OH

Vax Date: 10/15/2021
Onset Date: 10/16/2021
Rec V Date: 10/19/2021
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: None

Allergies: Keflex

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

Symptoms: Received the vaccine on Oct 15 at 2:00 pm. About 3:00 am, work up feeling achy, feverish and chilly. Took temperature at 10:00 am, it was 100 degrees. Felt very sick all day with aches, chills and nausea. Temperature climbed to 101 degrees in afternoon. I vomited 3 times when I tried to make dinner I could not stay awake, I kept falling asleep. I didn?t eat snuthing all day, no appetite. I started feeling better on October 17th. I was not able to eat much until October 19, because I was nauseated, gassy, and had no appetite.

Other Meds: Lexapro Crestor Jaurdiance Synthroid Metformin

Current Illness: None

ID: 1799476
Sex: M
Age: 59
State: CA

Vax Date: 09/03/2021
Onset Date: 09/08/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: medical exam on Sept 29th

Allergies: none

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Tinnitus: loud hissing sound 24hrs per day

Other Meds: none

Current Illness: none

ID: 1799477
Sex: F
Age: 39
State: IL

Vax Date: 10/06/2021
Onset Date: 10/18/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Na

Allergies: Zofran

Symptom List: Pharyngeal swelling

Symptoms: My period was 2 weeks late after the first dose and now with 2 dose i just got my period 10 days after my last one. So this is my 2nd period within the last 2 weeks . This has never happened to me.

Other Meds: Na

Current Illness: Na

ID: 1799478
Sex: F
Age: 45
State: CA

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: full blood panel, thyroid level checked, nothing abnormal.

Allergies: none

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Excessive hair loss all over scalp. Started after 1st dose of Covid Pfizer vaccine and increased dramatically after 2nd dose. Lost ~60% of hair over the next 3 months. Hair loss stopped on month 4 after vaccine and growing back.

Other Meds: Vit. D supplements, Synthroid

Current Illness: n/a

ID: 1799479
Sex: F
Age: 44
State: WI

Vax Date: 09/04/2021
Onset Date: 09/11/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: None, no insurance

Allergies: Vytorin

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Episodes of extreme tinnitus several times a day and night, sometimes for hours at a time! I've NEVER experienced this before.

Other Meds: None

Current Illness: None

ID: 1799480
Sex: F
Age: 65
State: CA

Vax Date: 10/15/2021
Onset Date: 10/16/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Blood clots in nose 10/16. Shingles like rash on torso since 10/16. Nausea on 10/16 and 10/17. Extreme fatigue on 10/16 and 10/17.

Other Meds: Carbamazepine

Current Illness: None

ID: 1799481
Sex: F
Age: 27
State: CA

Vax Date: 10/18/2021
Onset Date: 10/19/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: CT Scan 10/19/21: normal Chest X-ray 10/19/21: normal CBC with diff BMP

Allergies: NKA

Symptom List: Rash, Urticaria

Symptoms: Vasovagal syncope x3 with myoclonic jerking/ convulsions (loss of bodily control during: urination during convulsions)

Other Meds: Birth control: lo loestrin fe

Current Illness: N/A

ID: 1799482
Sex: F
Age: 38
State: AK

Vax Date: 10/04/2021
Onset Date: 10/05/2021
Rec V Date: 10/20/2021
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: fatigue that is still ongoing, migraine for 4 days, vomiting and Diarrhea, chills, fever aches all over body for a week. Bruising that started 7 days after the vaccine, I do not bruise easy and now if you touch me I get a bruise.

Other Meds:

Current Illness:

ID: 1799483
Sex: F
Age: 45
State: TX

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 10/20/2021
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: The hospital ran ekg, X-ray and blood work. Urinalysis was conducted at the walk in clinic.

Allergies: Penicillin and all sulfas

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

Symptoms: Spasms in chest, pain in chest, swelling of joints such as knees, wrists, fingers , feet and the areas I had my surgery (hysterectomy). I also felt body aches, headaches, tired and chills. I also had cramps in my legs and feet throughout the time. I felt sick for 7 days. I also had gone to clinic and they said I had a urine infection and it wouldn?t go away. A blood vessel also popped in my eye. I have a photo documenting my eye issue.

Other Meds: Over the counter Tylenol for pain

Current Illness: Had surgery (hysterectomy) on 01/13; vitamin deficiencies b12 and D3: anemia;

ID: 1799484
Sex: M
Age: 66
State: OR

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: none

Allergies: none

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

Symptoms: tiredness,headache,joint pain, nausea, during 12 - 24 hrs after booster shot. Just bed rest, plenty of water

Other Meds: none

Current Illness: none

ID: 1799485
Sex: F
Age: 54
State: IN

Vax Date: 09/19/2021
Onset Date: 09/24/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Notified my doctor. Rheumatology appointment in September 2022.

Allergies: None

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

Symptoms: Began having severe joint pain/back pain 5 days after 1st dose. Unable to lift legs to step up and unable to get up from seated position without assistance. I did already have joint pain before but it became unbearable after vaccine. After second dose I began having chest discomfort 2 days later. Joint pain still continues .

Other Meds: Victoza, Metformin, Glipizide

Current Illness:

ID: 1799486
Sex: F
Age: 52
State: TN

Vax Date: 08/28/2021
Onset Date: 10/19/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Today. 6 weeks after 2nd Pfizer dosage, I experienced extreme dizziness around 9am. The dizziness continued which makes it impossible to lie down to go to sleep. My head has to remain straight up to get some relief. I have never experienced anything of this sort. Today is the first day and it has persisted.

Other Meds: Triamterene

Current Illness: None

ID: 1799487
Sex: F
Age: 43
State: CO

Vax Date: 09/29/2021
Onset Date: 10/06/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: CBC, ESR, and CRP were drawn on 10/19/2021.

Allergies: latex

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Pt has developed severe L arm pain w/ mild swelling and warmth after getting her Moderna mRNA vaccination in the LUE. She reports the injection was given high in her shoulder. She was treated w/ diclofenac and cold compress. CBC, ESR, and CRP were drawn. Pt to follow up as needed.

Other Meds: Adderall, clonazepam, multivitamin, estradiol, prazosin, propranolol, sertraline, topamax, vit B12

Current Illness: Depression

ID: 1799488
Sex: F
Age: 42
State: NV

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: N/A

Allergies: Lactose Intolerance

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Hives at injection site and on face; itchiness at injection site and on face. Cool clothes on face and Benadryl. Hives subsided from face 1.5 hours later; not injection site. Hives subsided from injection site on Monday 10/18. Injection site still itchy, red and less sore.

Other Meds: Vitamin D, Xyzal, Echinacea

Current Illness: N/A

Date Died: 06/27/2021

ID: 1799489
Sex: F
Age: 55
State: NY

Vax Date: 05/06/2021
Onset Date: 05/20/2021
Rec V Date: 10/20/2021
Hospital: Y

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

Lab Data: ARDS 5/21 Septic infection 5/21 Fluid around chest area (Inflammation)5/21

Allergies: Dairy

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

Symptoms: She showed signs of shortness of breath and fatigue/ confusion less than 2 weeks after her first dose Was hospitalized and it was determined that she had an infection that was septic She had cardiovascular damage (blood pressure issues) Fluid build up in her body Nausea Joint and muscle pain Fatigue Injection potentially entered her bloodstream or blood vessel as she received it during her chemotherapy session

Other Meds: Levonox

Current Illness: Ovarian cancer Asthma

ID: 1799490
Sex: F
Age: 60
State: FL

Vax Date: 06/28/2021
Onset Date: 06/29/2021
Rec V Date: 10/20/2021
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: None at the time. I am working with a trainer to see if my arm will strengthen or symptoms will subside with exercise.

Allergies:

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

Symptoms: I had a seriously sore arm (Same as first dosage when given) that did not go away. Three weeks after the injection a large hematoma (bruise) appeared and my arm has continued to be achy and my hand with tremble occasionally if my arm rests in a certain position. I live part time in State and discussed this my doctor in City. It should be noted that the injection site was way lower than first shot.

Other Meds: 10 mg Paroxetine, .5mg clonazepam daily

Current Illness: None

ID: 1799491
Sex: F
Age: 34
State: TX

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/20/2021
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: started to feel extreamly hot,then dizzy, then fainted....co workers there to catch my fall. not 100% sure ont the type of influenza shot.

Other Meds:

Current Illness:

ID: 1799492
Sex: F
Age: 35
State: MO

Vax Date: 10/17/2021
Onset Date: 10/19/2021
Rec V Date: 10/20/2021
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: My left eyelid is bleeding without any known abrasion and my left arm is bleeding very easily. Merely touching my skin seems to be peeling it off.

Other Meds:

Current Illness:

ID: 1799493
Sex: M
Age: 36
State: IL

Vax Date: 10/11/2021
Onset Date: 10/12/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Doctor?s office visit and examination on Monday, October 18th, 2021.

Allergies: None

Symptom List: Injection site pain, Pain

Symptoms: Diagnosed with shingles. Symptoms began roughly 36 hours after first round of Moderna COVID-19 vaccine.

Other Meds: Ramipril, Amlodipine, and Hydrochlorothiazide

Current Illness: None

ID: 1799494
Sex: F
Age: 42
State: AZ

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: none

Allergies: codeine

Symptom List: Injection site pain, Menorrhagia

Symptoms: Immediate burning down my left arm to finger tips lasting 3 hrs after injection. Experienced massive headaches for 4 months after injection, requiring self dosing up to 1G of Tylenol q 6hrs each day to control. Current nerve pain in extremities.

Other Meds: none

Current Illness: none

ID: 1799495
Sex: M
Age: 37
State: ID

Vax Date: 04/22/2021
Onset Date: 05/01/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: 6/14/21, 5/3/21, 5/5/21, 5/9/21

Allergies: none

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

Symptoms: Extreme stomach discomfort, liquid diarrhea that lasted more than 45 days. Systemic full body hives that lasted 6 days a week following second Pfizer dose. Extreme biliary dysfunction. Extreme anxiety, panic attacks.

Other Meds: none

Current Illness: none

ID: 1799496
Sex: F
Age: 48
State: CO

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/20/2021
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: None

Allergies: Seasonal - grass

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Very painful right arm that swelled to double normal size, red and hot to touch, fever between 100.5 and 103 degreesF, severe headache, nausea, muscle aches snd fatigue. All symptoms lasted 48 hours except right arm pain, redness and swelling which resolved after 6 days.

Other Meds: Singulair, Flonase, Allegra, multivitamin

Current Illness: None

ID: 1799498
Sex: F
Age: 18
State:

Vax Date: 09/26/2021
Onset Date: 09/28/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Chest xray, complete blood count, vital check, ECG (Sept 29, 2021)

Allergies: None

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Chest tightness, racing heart, chills, cold sweats, insomnia, irritation, abnormal anxiety, fever, vomiting, diarrhea, light headiness, uncontrollable shaking

Other Meds: Birth Control: Alysensa 28

Current Illness: None

ID: 1799499
Sex: M
Age: 58
State: WA

Vax Date: 02/25/2021
Onset Date: 03/05/2021
Rec V Date: 10/20/2021
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: blood tests/lab work all normal after several tests. EKG abnormal - seeking additional medical evaluation by a cardiologist as recommended by my PCP. Nutripanel lab work normal. Glutamine helps with the nausea, Zofran ineffective.

Allergies: latex

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

Symptoms: ongoing unexplained frequent nausea, lethargy, joint pain, sweating with minimal exercise

Other Meds: Rosuvastatin, Multi B vitamin, B12, CoQ10, aspirin 81 mg, ashwaganda

Current Illness: None

ID: 1799500
Sex: M
Age: 22
State:

Vax Date: 10/13/2021
Onset Date: 10/19/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Troponin nl, EKG with ?pericarditis. Normal chest CT

Allergies: PCN

Symptom List: Nausea

Symptoms: Severe chest pain c/w pericarditis.

Other Meds: None

Current Illness: None

ID: 1799501
Sex: M
Age: 36
State: CA

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: None

Allergies: Toradol - reaction: rash/hives

Symptom List: Injection site pain

Symptoms: Headache, numbness, tingling to skin, nausea and vomiting x1.

Other Meds: Tylenol 650mg prn pain gabapentin 300mg bid lisinopril 20mg daily Vistaril 25mg QHS cephalexin 500mg po TID

Current Illness: None

ID: 1799502
Sex: F
Age: 36
State: CA

Vax Date: 04/01/2021
Onset Date: 05/01/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies: Sulfa based

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

Symptoms: Periods have be one irregular and significantly lighter.

Other Meds: N/A

Current Illness: N/A

ID: 1799503
Sex: F
Age: 88
State: OH

Vax Date: 01/24/2021
Onset Date: 10/18/2021
Rec V Date: 10/20/2021
Hospital: Y

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

Lab Data: 10/19/21-tested positive for covid

Allergies: sulfa

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

Symptoms: patient admitted to hospital due to covid symptoms

Other Meds: unknown

Current Illness: unknown

ID: 1799505
Sex: F
Age: 44
State: AZ

Vax Date: 08/29/2021
Onset Date: 08/30/2021
Rec V Date: 10/20/2021
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: Propylene glycol, gabapentin, cymbalta, amoxicillin, cipro

Symptom List: Tremor

Symptoms: Numbness/tingling in both arms and both legs, extreme weakness in both arms and both legs, extreme, heightened anxiety and panic attacks, chronic headaches, dizziness, lightheadedness

Other Meds: None

Current Illness: None

ID: 1799506
Sex: M
Age: 35
State: VA

Vax Date: 10/17/2021
Onset Date: 10/18/2021
Rec V Date: 10/20/2021
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: None

Symptom List: Erythema, Pruritus

Symptoms: Started getting hives at night after vaccination.

Other Meds: Lisinopril, Zyrtec, Daily Vitamin

Current Illness: None

ID: 1799507
Sex: F
Age: 24
State:

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: -

Allergies: No

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

Symptoms: In first vaccine I had a week long back pain. Shoulder , back neck area. Didnt move my head because of pain a week.Second vaccine fever at night a lot of nightmares.

Other Meds: No

Current Illness: No

ID: 1799877
Sex: M
Age: 28
State: CO

Vax Date: 05/05/2021
Onset Date: 05/07/2021
Rec V Date: 10/20/2021
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: Mild but persistent fever alleviated by Advil. Chest "soreness" started 2 days in, pounding heart and cold sweats and arm pangs went in and out over the next two days. Only comfortable with chest vertical. Symptoms abruptly vanished after 2 nights of this.

Other Meds: Advil Nyquil

Current Illness:

ID: 1799991
Sex: F
Age: 70
State: GA

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/20/2021
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: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1800075
Sex: F
Age:
State: PR

Vax Date: 04/20/2021
Onset Date: 05/12/2021
Rec V Date: 10/20/2021
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: Hives and rash on skin; Hives and rash on skin; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for female patient that, A 19-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0169) (at the age of 19 years old), dose 1 via an unspecified route of administration, administered in arm left on 20Apr2021 as dose 1, single, dose 2 via an unspecified route of administration, administered in arm left on 11May2021 10:00 (Formulation: Solution for injection, Batch/Lot Number: EW0179) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid (VITAMIN-C) taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. It was reported that on 12May2021 17:30 patient experienced urticaria and rash on skin. No treatment was received for events. No known allergies was reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Outcome for events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN-C

Current Illness:

ID: 1800175
Sex: F
Age:
State: FL

Vax Date: 08/28/2015
Onset Date: 03/27/2016
Rec V Date: 10/20/2021
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: random onset alopecia areata; biliary dyskinesia; irritable bowel syndrome; small intestinal bacterial overgrowth; bile acid malabsorption; temporomandibular joint disorder; postural orthostatic tachycardia syndrome; dysautonomia; Information has been received from a lawyer referring to a 19 years old female patient regarding a case in litigation. The patient was in her usual state of health, and enjoying her life. Information about history condition and concomitant medication was not reported.On 28-AUG-2015, during a routine visit to discuss birth control, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not reported) for preventing cervical cancer, in light of the physician's recommendations, as well as relentless marketing and advertising messages. Within a month of receiving the first dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient developed symptoms of fatigue, headaches, joint pains, dizziness, and brain fog. On 27-OCT-2015(also reported as 27-OCT-2915, inconsistent information), the patient returned to the physician's office to receive her second dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not reported). Immediately following the shot, the patient became suddenly dizzy and felt intense pain in her arm where the vaccine had been administered. The patient was instructed to sit in a chair for a few minutes until she felt well enough to walk out of the office. The pain in her arm and the dizziness continued for many days. The patient also continued to experience severe joint pains, which eventually worked their way into her jaw. The left side of her jaw would ache until she could not eat or speak. The patient saw her dentist and was diagnosed with temporomandibular joint disorder (TMJ). In October 2015, the patient quit her job due to fatigue, dizziness, and generalized pain. The physical fatigue and mental brain fog she experienced made doing even the simplest tasks nearly impossible. By February 2016, the patient was experiencing increasingly severe stomach pains and nausea. She also suddenly developed anxiety, depression, and panic attacks. She had to miss school or leave early from her classes because she was in so much pain that she couldn't focus or would have a panic attack in the middle of class. The patient stopped being able to drive to school and she had to rely on her father for a ride. On 14-MAR-2016, the patient returned to her physician's office, for her third and final dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not reported). On 27-MAR-2016, the patient woke up with a patch of hair missing from the top of her head. She had a bald spot the size of a quarter right above her forehead, and the spot continued to grow over the days until it was about 2 inches in diameter. The patient was diagnosed with random onset alopecia areata. In May 2016, the patient was very ill with stomach pains and nausea. She was suddenly unable to eat or drink anything despite being hungry and wanting to eat. She could not swallow anything. She went from doctor to doctor trying to find answers for around two weeks until she finally had a hepatobiliary iminodiacetic acid (HIDA) scan. It was found that her gall bladder was deemed "non-functioning" at zero percent. On 13-JUN-2016, an emergency surgery was performed to remove the gall bladder. After the surgery, the patient was able to eat again, but her abdominal pain persisted and in fact worsened. As the months progressed, so did the patient's injuries. She was seen by multiple physicians and specialists for her complaints which now included: dizziness, brain fog, joint pains, swallowing issues, breathing difficulties, fatigue, hair loss, severe stomach issues, vitamin/mineral deficiencies, muscle weakness, severe weight loss, insomnia, tachycardia, insomnia, anxiety, depression, panic attacks, and obsessive-compulsive disorder (OCD) behaviors. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient was unable to engage in normal activities that a young adult would enjoy. She could no longer be physically active, nor participate in the activities that she used to. The patient has taken time off from college and has put her dreams of working in the film industry on hold to focus on her health. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms and adverse events as outlined above, and the tests performed by her medical providers, the patient had been diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome (POTS), dysautonomia, alopecia areata, biliary dyskinesia, irritable bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO), bile acid malabsorption (BAM), and TMJ. The patient had suffered and continued to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The patient also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the patient had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she (also reported as he, inconsistent information) would continue to incur these losses and expenses in the future. The outcome of all events was not recovered. The causality assessment was considered to be related by the lawyer. These events of POTS, dysautonomia, alopecia areata, biliary dyskinesia, IBS, SIBO, BAM, and temporomandibular TMJ were considered as disability by the lawyer. The event of biliary dyskinesia was determined to be medically significant because the surgery of remove the gall bladder was on supplemental surgical and medical procedures always serious terms list.

Other Meds:

Current Illness:

ID: 1800179
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had the shingles shot but got shingles anyway. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.

Other Meds:

Current Illness:

ID: 1800181
Sex: F
Age:
State: WI

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: (Test Result:over 105,Unit:degree F,Normal Low:,Normal High:)

Allergies:

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

Symptoms: DPT shot, probably the pertussis/ suspected vaccination failure; probably the pertussis; had a temp of over 105; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the vaccination failure, pertussis and fever were unknown. The reporter considered the vaccination failure, pertussis and fever to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by patient's parent. The age at vaccination was not reported. The patient had a temperature of over 105 degree F from the DPT shot. The reporter stated that they said it was probably the pertussis. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for pertussis and time to onset were unknown.

Other Meds:

Current Illness:

ID: 1800198
Sex: M
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: fainted; diarrhea; vomiting; nausea; Knees buckled; severe gastrointestinal effects; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder. On an unknown date, the outcome of the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder were recovered/resolved. It was unknown if the reporter considered the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. 2 weeks ago, from reporting date, the patient received 1st dose of Shingles and 8 hours after vaccination experienced knees buckled, fainted, and had severe gastrointestinal effects including nausea, vomiting and diarrhea. The patient did not provide vaccine facility details and enquired if he should receive 2nd dose of Shingles vaccine. The patient also enquired if he could have the flu vaccine at the same time as the shingles vaccine.

Other Meds:

Current Illness:

ID: 1800200
Sex: F
Age: 92
State: TX

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/20/2021
Hospital: Y

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: difficulty breathing; potential signs and symptoms of Guillain-Barre syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 5P9DR, expiry date 20th March 2023) for prophylaxis. On 13th October 2021, the patient received Shingrix. On 13th October 2021, less than a day after receiving Shingrix, the patient experienced difficulty breathing (serious criteria hospitalization) and guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On 14th October 2021, the outcome of the difficulty breathing and guillain barre syndrome were recovered/resolved. It was unknown if the reporter considered the difficulty breathing and guillain barre syndrome to be related to Shingrix. Additional details were provided as follows: The patient had received Shingrix vaccine on and 1 to 2 hours later experienced difficulty breathing and potential signs and symptoms of Guillain-Barre syndrome. The patient was admitted to the hospital for observation. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1800209
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Lot of people who took 2nd shot have been sick for 3 and 4 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days). At the time of the report, VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days) outcome was unknown. No concomitant medications were mentioned. No treatment details were reported. This case was linked to MOD-2021-348466 (Patient Link).

Other Meds:

Current Illness:

ID: 1800210
Sex: F
Age: 34
State: WV

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies: Stadol Latex

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: With Dose #1, within 24 hours of receiving the dose on 9/10/21 at 4:00pm, I had extremity numbness from my elbows to my fingertips, my knees to my toes, along with tingling in my extremities along with my face and nose tingling as well, I had nausea and diarrhea. With Dose #2 within 2 hours of receiving the dose on 9/30/21 at 6:45pm, i had continued extremity numbness and tingling along with my face and nose, as well as sharp pains in the center of my eyes, nausea, and vomiting. It is 10/20/21 and those symptoms have remained.

Other Meds: Celexa 80mg

Current Illness: None

ID: 1800212
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: BLOOD CLOT; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This solicited report received from a consumer via PPSCVM000808: concerned a female of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient advised that she got the vaccine, got a blood clot and then got covid (coded as suspected covid-19 infection, suspected clinical vaccination failure) (Covid was post taking Xarelto). It was not confirmed if other events were before or after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of the suspected covid-19 infection, blood clot and suspected clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clot, suspected clinical vaccination failure, and suspected covid-19 infection was not related; and between rivaroxaban, and blood clot, suspected clinical vaccination failure, and suspected covid-19 infection was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021089-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211021089-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20211021089-rivaroxaban-Blood clot. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211021089-rivaroxaban-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1800213
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Negative

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This solicited report received from literature:Response to SARS-CoV-2 vaccination in patients after hematopoietic cell transplantation and CAR T-cell therapy. Jansen COVID-19. This report concerned multiple patients (two patients) of unspecified age, sex, race and ethnicity. The objective of this study was to describe, response to SARS-CoV-2 vaccination in patients after hematopoietic cell transplantation and chimeric antigen receptor (CAR) T-cell therapy. The patient's height, and weight were not reported. The patient's concurrent conditions included: haematological malignancy. The patients initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry was unknown) frequency time 1 total, dose, start therapy date were not reported for Prophylactic vaccination. The batch number was not reported and has been requested. Concomitant therapy included hematopoietic cell transplantation (HCT) and chimeric antigen receptor (CAR) T- cell therapy. On an unspecified date, the patients underwent SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody test, which was negative. The blood samples were tested using an enzyme immunoassay (EUROIMMUN) that tests for antibodies to the S1 domain of the SARS-CoV-2 spike protein (suspected immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. The reporter provided no causality assessment. Company causality between Covid-19 vaccine ad26.cov2.s, and suspected immunological vaccine failure was not related. The authors concluded, the findings of low antispike antibodies in patients undergone HCT and receiving CAR T-cell therapy after COVID-19 vaccination suggest that such patients might remain at high risk of COVID-19 infection despite vaccination. The results observed in this study underscore the importance of masking, social distancing, and household vaccination for patients undergoing HCT and receiving CAR T-cell therapy, even after vaccination. Additional studies examining the wider immune repertoire with characterization of memory B- and T-cell immune responses over time and neutralizing antibody capacity are needed to better assess immunological response. In patients who do not achieve optimal immune response, studies examining the role of booster doses or revaccination are needed. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint number 90000197786. This case, from the same reporter is linked to 20210948620, 20210732170, 20210302465, 20210102329, 20210415497, 20191102087, 20210441941, 20210359826, 20210317981, 20200115362 and 20191102112.; Sender's Comments: V0:20211021158-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, SPECIAL SITUATIONS

Other Meds:

Current Illness: Haematological malignancy (HCT and CAR-T cell therapy)

ID: 1800214
Sex: F
Age:
State: CT

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

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Name: Lab test; Result Unstructured Data: improved; Test Name: Computerised tomogram head; Result Unstructured Data: no acute abnormalities; Test Name: MRI brain; Result Unstructured Data: white matter signal abnormalities; Test Name: Ferritin; Result Unstructured Data: 937 mcg/L; Test Name: C-reactive protein; Result Unstructured Data: 47.3 mg/L; Test Name: NT-proBNP; Result Unstructured Data: Elevated; Test Name: Lab test; Result Unstructured Data: negative; Test Name: Lab test; Result Unstructured Data: negative; Test Name: COVID-19 antibody test; Result Unstructured Data: positive; Test Name: Antibody test; Result Unstructured Data: positive; Test Name: Liver biopsy; Result Unstructured Data: consistent with acute hepatitis; Test Name: Bone marrow biopsy; Result Unstructured Data: negative for HLH; Test Name: Lumbar puncture; Result Unstructured Data: opening pressure of 27 cm H20; Test Name: Lab test; Result Unstructured Data: negative; Test Name: Lab test; Result Unstructured Data: notable for leukopenia; Test Name: Hepatic enzyme; Result Unstructured Data: elevated; Test Name: Transaminases; Result Unstructured Data: greater than 2000 IU/L, worsening; Test Name: Computerized tomogram abdomen; Result Unstructured Data: unremarkable

Allergies:

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

Symptoms: ENCEPHALOPATHY; SEIZURE; ACUTE HEPATITIS; PHOTOPHOBIA; CHILLS; FEVER; This spontaneous report was received from literature. This report concerned a 21 year old female. The objective of this case report study was to describe Multisystem Inflammatory Syndrome in Children and Adolescents (MIS-C) in a young adult with recent vaccination. The patient's height, and weight were not reported. The patient's past medical history included: asymptomatic COVID infection, and concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, two weeks after vaccination, the patient was presented to the emergency department (ED) with fevers, chills and photophobia. On evaluation, COVID test was negative. Labs were notable for leukopenia, elevated liver enzymes. The patient was admitted to the medical floor. Date of hospitalization was not reported. The patient's course was complicated by worsening transaminases greater than 2000 IU/L with progressive encephalopathy. The patient had witnessed seizure activity requiring intubation and transfer to the Intensive Care Unit (ICU). Laboratory data included: Computed Tomography (CT) abdomen was unremarkable. Head CT showed no acute abnormalities. Brain Magnetic Resonance Imaging (MRI) showed diffuse nonspecific white matter signal abnormalities. Additional lab work revealed ferritin of 937 mcg/L, and CRP of 47.3 mg/L and an elevated NT-proBNP. Film array and hepatitis panel was negative. COVID spike and nucleocapsid antibodies were both positive. The patient underwent a liver biopsy which was consistent with acute hepatitis and bone marrow biopsy which was negative for Hemophagocytic lymphohistiocytosis (HLH). Lumbar puncture with elevated opening pressure of 27 cm H20. Extensive infectious workup for bacterial, fungal and viral etiologies were negative. The patient met criteria and was diagnosed with Multisystem Inflammatory Syndrome in Children and Adolescents. The patient received high dose Intravenous Dexamethasone, Intravenous Immunoglobulin (IVIG) and anakinra infusion. The lab work and encephalopathy improved and patient was discharged home. Date of discharge and number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from multisystem inflammatory syndrome in children and adolescents (MIS-C) in a young adult. The authors concluded that it was currently unknown if Multisystem Inflammatory Syndrome in Children and Adolescents might follow COVID immunization, but a need exists to define this potential entity for monitoring as a potential adverse event. It is also important to maintain an index of suspicion for this disorder. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from literature concerned a 21-year-old female who experienced multisystem inflammatory syndrome 14 days after vaccination. Medical history includes asthma. Concomitant medications were not reported. The patient presented to the emergency department 2 weeks after vaccine with fever, chills, and photophobia. Initial labs showed leukopenia, elevated liver enzymes and the patient was admitted to the medical floor. The clinical course was complicated by elevated transaminases (>2000 IU/L), progressive encephalopathy and seizure activity requiring intubation and transfer to the intensive care unit. Additional labs include ferritin 937 mcg/L, and CRP of 47.3 mg/L, pro-BNP high, hepatitis panel negative, and a negative COVID test (unspecified type). COVID spike and nucleocapsid antibodies were positive. MRI brain showed diffuse nonspecific white matter abnormalities. Liver biopsy showed acute hepatitis, and Bone marrow biopsy was negative for hemophagocytic lymphohistiocytosis. Extensive workup for bacterial, fungal, and viral etiologies was negative and criteria for multisystem inflammatory syndrome in children and adolescents was met. The patient's condition improved and was discharged home after treatment with high dose dexamethasone, IVIG, and anakinra infusion. A recent asymptomatic COVID-19 infection (indicated by positive nucleocapsid antibodies) may have increased the risk for the event to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.

Other Meds:

Current Illness: Asthma

ID: 1800215
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20211009; Test Name: COVID-19 virus test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: SUSPECTED COVID-19 INFECTION; LITTLE DIZZY FEELING; PRESSURE ON FOREHEAD; HEAD CONGESTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced suspected covid-19 infection. On OCT-2021, the patient experienced little dizzy feeling. On OCT-2021, the patient experienced pressure on forehead. On OCT-2021, the patient experienced head congestion. On 09-OCT-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on OCT-2021, and the outcome of little dizzy feeling, pressure on forehead and head congestion was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am