VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1066485
Sex: M
Age: 70
State: AK

Vax Date: 12/31/2020
Onset Date: 01/03/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List:

Symptoms: Five weeks of violent coughing of phlegm from the lungs, followed by two weeks of light-to-moderate coughing of sinus mucus. Five days of antibiotics (seemed to mitigate), daily nebulizing with saline and hydrogen peroxide solution, plus flushing sinuses with saline solution via neti pot.

Other Meds: Amour Thyroid, Lisinopril, Metoprolol, Clopidogrel, Aspirin

Current Illness: None

ID: 1066486
Sex: M
Age: 67
State: WI

Vax Date: 02/05/2021
Onset Date: 02/22/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Bee venom

Symptom List:

Symptoms: Lightheadedness Bilateral arm paresthesia

Other Meds: Atorvastatin 20mg QD Dicyclomine 20mg QID PRN

Current Illness: None

ID: 1066487
Sex: F
Age: 38
State: OK

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Lyrica

Symptom List:

Symptoms: severe headache beginning after a few hours and still occurring 26 hours after injection, minor injection site pain beginning morning after

Other Meds: duloxetine, nexium, iron supplement, zyrtec, multi-vitamin, melatonin, tizanidine, simvastatin, lisinopril, vitamin d supplement

Current Illness: none

ID: 1066488
Sex: F
Age: 57
State: MO

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: seasonal allergies

Symptom List:

Symptoms: confused, 102.7 fever, headache, chills, Charlie horses in both upper legs and couldn't walk, injection site very painful

Other Meds: Amlodipine Besylate (amLODIPine) 2.5 MG Ascorbic Acid (Vitamin C Tablet) 500 MG 2 TAB ORAL Daily Aspirin (Aspirin EC) 81 MG Calcium/Vit D NOS 2 TAB ORAL Daily Ergocalciferol (Vitamin D2) (Vitamin D2) 50,000 UNIT Escitalopram Oxalate (Lexa

Current Illness: tested positive for COVID19 on 01/11/2021

ID: 1066489
Sex: F
Age: 78
State: ME

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Administered 3rd dose of Pfizer vaccine in error

Other Meds:

Current Illness:

ID: 1066490
Sex: F
Age: 32
State: TX

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Sulfa Drugs

Symptom List:

Symptoms: Throbbing pain, swelling, and redness at injection site Headache Fatigue Muscle Aches Chills

Other Meds: Wellbutrin XR 450mg/day Vyvanse 40mg/day Birth control Flonase

Current Illness: none

ID: 1066491
Sex: M
Age: 62
State: GA

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: penicillin and tamaflu

Symptom List:

Symptoms: Fever, Congestion, Cough, Muscle Ache, Headache, Lethargy and Nausea

Other Meds: famotidine and xyzal

Current Illness: covid-19

ID: 1066492
Sex: F
Age: 36
State: CA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Systemic: Fainting / Unresponsive-Medium, Additional Details: wjile monitoring pt after giving the vaccine , she fainted but after few minutes she said she is feeling berrer, refused us to call 911 she said she panics quick and had history of panic attack

Other Meds:

Current Illness:

ID: 1066493
Sex: M
Age: 54
State: CA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Pt was to receive Pfizer vaccine. Had multiple doses of Moderna available on table and a single Pfizer dose. Proceeded to administer Moderna dose into the left arm of Pt around 1030. Pt was informed directly afterward, and was given appointment 1 week from March 2, 2021 to receive 2nd Pfizer dose.

Other Meds:

Current Illness:

ID: 1066494
Sex: F
Age: 78
State: OH

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Ace-inhibitors - Zestril and Fosomax

Symptom List:

Symptoms: Moderna rec'd last Thursday, the injection was pushed in deep and by the evening the pain at the injection site was unbearable, she injected pretty high in my arm and it started to sting. After 4 hours the pain was unbearable and my range of motion was limited and the it feels very hot. I cant sleep because of the pain and have to take Motrin to even function.

Other Meds: Olmesartan Medoxomil (Benicar) 10mg Simvastatin Tab (Zocar) 10mg

Current Illness: No

ID: 1066495
Sex: F
Age: 64
State: MO

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Mold, mildew

Symptom List:

Symptoms: Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen after 5 days. Overall itchy, but no rash. Thursday-Saturday diarrhea and lethargy Some intermittent vertigo. Rest, fluids, Tylenol and benedryl

Other Meds: Amlodipine, losartan, Celebrex, omeprozole , symbacort, nasacort

Current Illness: None

ID: 1066496
Sex: F
Age: 66
State: OH

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Cats, dogs, grass, dust Prednisone Fluoxetine

Symptom List:

Symptoms: My arm was very sore the evening of vaccine and the next day. Later the day after I had a headache and felt nauseous. I keep getting headaches on and off. Sometimes dizzy. The nausea is almost all the time. It has not improved. It has been one week.

Other Meds: Nexium Montelukast Vitamin D3 Probiotics Atorvastatin Cetrizine Weekly allergy shots Bayer low dose vitamin QVAR inhaler

Current Illness: None After the COVID vaccine I still have the headache on and off but the nausea is almost constant

ID: 1066497
Sex: F
Age: 86
State: IN

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Error: Booster Given Too Early

Other Meds:

Current Illness:

ID: 1066498
Sex: F
Age: 70
State: TN

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List:

Symptoms: Experienced Dizziness after the Pfizer vaccine. I waited 15 minutes on site and experience the dizziness the entire time. I left after the 15 minutes and still had slight disorientation. After 30 minutes I fell normal.

Other Meds: Allergy Nasal Spray over-the-counter

Current Illness: None

ID: 1066499
Sex: M
Age: 38
State: NY

Vax Date: 02/25/2021
Onset Date: 02/27/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Erythromycin, Penicillins, Sulfa

Symptom List:

Symptoms: 38 year old male presented to the ED with weakness to the left side of the face beginning 45 minutes prior to arrival. He stated that he had his COVID vaccine 2 days prior. He states the day after he began to lose his sense of taste and he has a weird feeling in his right arm as well. Diagnosed with Bell's Palsy. Started on valacyclovir as well as a prednisone taper.

Other Meds: methylphenidate 10mg BID, Aleve 220mg Qday

Current Illness:

ID: 1066500
Sex: F
Age: 32
State: NY

Vax Date: 01/02/2021
Onset Date: 01/11/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None. Environmental allergies only

Symptom List:

Symptoms: Gestational hypertension developed on 1/11. Increased edema of feet, diastolic pressures 95-105. Was sent to the emergency room by the OB team for observation. Was discharged without starting any medications

Other Meds: Pre natal vitamins, monthly allergy shots

Current Illness: None

ID: 1066501
Sex: M
Age: 68
State: IL

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Morphine

Symptom List:

Symptoms: Light headedness, balance issues; nausea intermittent over 5 days Primary care doctor not consulted Second dose on 2/27/2021-no side effects

Other Meds: Metformin;Valsart:Atorvastatin;Naproxen;Dutasteride;asprin-81m

Current Illness: none

ID: 1066502
Sex: F
Age: 38
State: CA

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Latex

Symptom List:

Symptoms: The next day of vaccination I had my lymph node swollen on the axilla on my right arm. It lasted for almost 3 weeks. Talked to a doctor where I worked & he said to massage the area.

Other Meds: Naproxen

Current Illness:

ID: 1066503
Sex: F
Age: 75
State: VA

Vax Date: 02/15/2021
Onset Date: 02/26/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt diagnosed w/ a staph infection 2 weeks after first dose shot

Other Meds:

Current Illness:

ID: 1066504
Sex: F
Age: 71
State: AR

Vax Date: 02/13/2021
Onset Date: 02/23/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: I developed hives between my breasts and on my chest within 10 days after receiving the second dose of the COVID 19 vaccine from Pfizer. It was very itchy and red and uncomfortable. Anytime clothing touched it, it was itchy.

Other Meds: Saffron, turmeric, calcium, astragalus, Vitamin C

Current Illness:

ID: 1066505
Sex: M
Age: 79
State: IL

Vax Date: 02/18/2021
Onset Date: 03/01/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Iodine Revlimid Heart trouble

Symptom List:

Symptoms: Sore left arm Red raised rash about 2" by 4" inches appeared on the 11th day at site of injection for about 30 hours

Other Meds: Metoprolol 25 mg, Atorvastatin 40 mg, lllllll81 mg aspirin, omeprazole 40 mg, Ondanesetron 8l mg, Multi-vitamin with iron, Flexeril, Denosumab, Potassium, Prednisolone 1%, Restasis EMU .05%, Acyclovir 400mg, Sulfamethaoxazole 160mg, Alpr

Current Illness: Bad cold one month prior - Tested negative COVID

ID: 1066506
Sex: F
Age: 89
State: OH

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: no

Symptom List:

Symptoms: symptoms on second day was tiredness, feeling unwell, chills, fever, muscle pain and diarea.

Other Meds: Acetaminophen 500mg x3 x 2-3times/day aspirin 81mg bimatoprost 0.01% eye drop Combigan 0.2-0.5% eye drop x2 times/day COQ-10 400mg ergocalciferol 50000 unit 1 every other week esomeprazole 20mg gabapentin 300mg x2 x2times/day Ibandronate 15

Current Illness: no

ID: 1066507
Sex: F
Age: 73
State: FL

Vax Date: 02/15/2021
Onset Date: 02/22/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: codeine ibuprofen Keflex latex

Symptom List:

Symptoms: Had no symptoms for 1 week after injection. Then began with swelling, redness, itching, pain and heat at the injection site. Got very swollen. Took allergy medication. It is still red, itchy and swollen today but slowly improving since then.

Other Meds: Zolpidem, Sertraline, Rosuvastatin, fenofibrate, milk thistle, prebiotic, vitamin D3, Xyzal

Current Illness: No acute illness

ID: 1066508
Sex: F
Age: 24
State: CA

Vax Date: 02/19/2021
Onset Date: 02/21/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Patient received Moderna Vaccine # 1 on 2/19/2021. On Sunday 2/21/2021 at 9am patient noted both lower extremities covered in hives, and both ears were red and swollen.

Other Meds:

Current Illness:

ID: 1066509
Sex: F
Age: 79
State: NY

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Systemic: Exhaustion / Lethargy-Mild, Systemic: tingling all over. patient reported feeling better after about 20-30 minutes of watching/waiting.-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in extremities

Other Meds:

Current Illness:

ID: 1066510
Sex: F
Age: 59
State: VA

Vax Date: 02/24/2021
Onset Date: 02/26/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Penicillin

Symptom List:

Symptoms: Dizziness within 24 hours, extreme vertigo needing medical treatment within 48 hours. Extreme fatigue beginning immediately after injection.

Other Meds: None

Current Illness: None

ID: 1066511
Sex: F
Age: 79
State: GA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: pollen, mold, cats, antibiotics

Symptom List:

Symptoms: headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issues

Other Meds: low dose thyroid 25mcg

Current Illness: irrital bowel syndrome

ID: 1066512
Sex: F
Age: 25
State: TX

Vax Date: 02/10/2021
Onset Date: 02/16/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Exhaustion, insomnia, fever, swollen lymph node in right underarm. Painful to the tough and without. Grew to size of a golf ball.

Other Meds: Metformin, birth control, synthroid, phentermine

Current Illness: PCOS, hypothyroidism

ID: 1066513
Sex: M
Age: 38
State: CA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild

Other Meds:

Current Illness:

ID: 1066514
Sex: M
Age: 54
State: LA

Vax Date: 02/12/2021
Onset Date: 02/14/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Sulfa Drugs

Symptom List:

Symptoms: A few hours after injection, pain and swelling at the injection site (far upper right arm) lasting about 1 week. On approx. day 2 post injection, began experiencing pain and limited range of motion of my left shoulder.

Other Meds: Singular 10MG Rosuvaststin 5mg Flonase Protonix 40mg Tagamet 400mg Zyrtec 10mg Supplements: Vitamin D3 2000 IU CoQ10 200mg B Complex Multivitamin Calcium 800mg Probiotic & Prebiotic Iron 22mg Turmeric

Current Illness: None

ID: 1066515
Sex: F
Age: 87
State: CA

Vax Date: 02/01/2021
Onset Date: 02/21/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Sulfa, Iodine, Bacitracin, Polysporine, Neosporin, Aygestin, Lotrel, Dyazide, Furosemide, Morphine, Norvasc, jAcetphenomin, Azor, Premorin

Symptom List:

Symptoms: Intense, severe itching in low back by spine, more I scratched the worse it got. Came on suddenly, no warning. Lasted a good 20 minutes, very inflamed. Retired at 10:30 pm and it subsided. Back was clear in morning. Also, my right upper arm is still sore this 13th day after shot.

Other Meds: Hydrazine, Bystolic, Levothyroxine, Metformin HCL, Vitamin E, 250 mg, Clonodine,

Current Illness: None

ID: 1066516
Sex: M
Age: 15
State: PA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Error: Patient Too Young for Vaccine Administered

Other Meds:

Current Illness:

ID: 1066517
Sex: F
Age: 62
State: GA

Vax Date: 02/12/2021
Onset Date: 02/26/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None.

Symptom List:

Symptoms: Had the vaccine on 2/12/21, was doing okay, had nausea and chills. Then on Friday 2/26/21 felt like she was hit with a ton of bricks, and went to the Urgent Care to do a COVID test, and they told her they could not read it on 2/27/21. She went to Hospital ER last night and had another COVID test and was diagnosed with the COVID virus, and told to go in the morning for an infusion. Went this morning to Hospital Infusion center where they gave her an infusion to fight off the virus. They told her to wait 90 days before she receives the 2nd vaccine injection.

Other Meds: Multivitamin, Clonidine Atorvastatin, Hydralazine, aspirin, Lantus.

Current Illness: None.

ID: 1066518
Sex: M
Age: 79
State: VA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List:

Symptoms: Chills overnight starting 6:00 pm 26 February 2021 and lasting until midday on 27 February 2021. I put on extra blankets and slept okay in my own bed. Appetite remained good.

Other Meds: Amlodipine

Current Illness: None

ID: 1066519
Sex: M
Age: 19
State: IL

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: N/A

Symptom List:

Symptoms: Patient experienced lightheadedness after vaccination and fell down. He was able to get up and sit on chair after 1 minute. We offered water, checked blood pressure (92/78). Ambulance arrived and patient went to hospital. Will follow up how he's doing later today.

Other Meds: Moderna Covid vaccine

Current Illness: N/A

ID: 1066532
Sex: F
Age: 65
State: IN

Vax Date: 10/30/2020
Onset Date: 10/30/2020
Rec V Date: 03/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

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Symptom List:

Symptoms: Arm soreness; Swelling at injection site; Whole body achiness; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th October 2020, the patient received the 1st dose of Shingrix. On 30th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain, pain in arm and injection site swelling. On an unknown date, the outcome of the general body pain, pain in arm and injection site swelling were recovered/resolved. It was unknown if the reporter considered the general body pain, pain in arm and injection site swelling to be related to Shingrix. Additional details were provided as follows: The reporter stated that, after vaccination, the patient experienced whole body achiness that presented in vaccination night but it resolved by day 4. The patient had arm soreness and swelling at injection site after the first dose that resolved within 4 days. The reporter consented to follow up. For the tolerence of dose 2 refer case US2021002010, reported by same reporter for same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021002010:Same reporter

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ID: 1066533
Sex: F
Age: 65
State: IN

Vax Date: 12/30/2020
Onset Date: 01/03/2021
Rec V Date: 03/02/2021
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Symptoms: Felt weak specifically in her legs; Felt lethargic; Nauseous; Had episodes of diarrhea; Sweating in the day; Hot at night; Loss of appetite; Silly cough as she described it; Swelling at injection; Arm soreness; Severe whole body achiness; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain (1st dose received on 30th October 2020,for further tolerance of 1st dose refer case US2021AMR002816). On 30th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, pain in arm and general body pain. On 3rd January 2021, the patient experienced lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and pain in arm were recovered/resolved and the outcome of the general body pain, lower extremities weakness of, lethargy, nausea, sweating, feeling hot, appetite lost and cough were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving. It was unknown if the reporter considered the injection site swelling, pain in arm, general body pain, lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough to be related to Shingrix. Additional details were provided as follows: The patient received 2nd dose and experienced early in the morning the following day, she felt severe whole body achiness. By the 4th day other symptoms presented,felt weak specifically in her legs,lethargic, nauseous, had episodes of diarrhea, sweating in the day and hot at night, loss of appetite and a silly cough, arm soreness and swelling at the injection which resolves by day 4. The reporter stated that the symptoms listed in this report following the second dose have not resolved with the exception of the injection site reactions. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR002816:Same reporter

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ID: 1066534
Sex: M
Age:
State: IN

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Symptoms: Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown. It was unknown if the reporter considered the diarrhea to be related to Shingrix. Additional details were provided as follows: Th reporter was patient's mother. The age at vaccination was not reported. The patient received Shingrix and experienced diarrhea. The reporter did not consent to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021005930:Same reporter US-GLAXOSMITHKLINE-US2021005938:Same reporter

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ID: 1066535
Sex: M
Age: 59
State: TX

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 03/02/2021
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Symptoms: left arm is Sore and Tender; Jaw Swollen; in itching Hives "from head to toe".; Itching hives from head to toe; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 28th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2021, 8 hrs after receiving Shingrix, the patient experienced hives and pruritus. On 29th January 2021, the patient experienced facial swelling. On an unknown date, the patient experienced pain in arm. On 29th January 2021, the outcome of the hives and pruritus were recovered/resolved. On an unknown date, the outcome of the facial swelling was recovering/resolving and the outcome of the pain in arm was unknown. The reporter considered the facial swelling, hives and pruritus to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The patient broke out in itching Hives from head to toe. On 29th January, he woke up at 4:00 AM to find his Jaw Swollen, the swelling had decreased. He also reported that his left arm was sore and tender. The reporter did not consent to follow-up.

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Current Illness:

ID: 1066536
Sex: M
Age:
State: FL

Vax Date: 02/14/2021
Onset Date: 02/15/2021
Rec V Date: 03/02/2021
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Symptoms: two bad episodes of Atrial Fibrillation; slept for like a day and a half; Felt lethargic; A spontaneous report was received from two consumers and a healthcare professional concerning a male patient of unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced two bad episodes of Atrial Fibrillation, Slept for like a day and a half and Felt lethargic. The patient's medical history included Atrial Fibrillation. Products known to have been used by the patient, within two weeks prior to the event, included Multaq, at 400mg two times a day for Atrial Fibrillation. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: not provided). On 14 FEB 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced two bad episodes of Atrial Fibrillation, slept for like a day and a half and felt lethargic. No treatment was given for the reported events. The action taken with mRNA-1273 in response to the events was considered not applicable, as the patient received both the doses of Moderna's COVID-19 vaccine prior to the events. The outcome of the events was unknown.; Reporter's Comments: This case concerns a male patient, with medical history of atrial fibrillation, who experienced a serious unexpected event of atrial fibrillation, after receiving second dose mRNA- 1273 (Lot# 029K20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the patient's history of atrial fibrillation. Further information has been requested.

Other Meds: MULTAQ

Current Illness:

ID: 1066537
Sex: F
Age: 73
State: AR

Vax Date: 01/19/2021
Onset Date: 01/23/2021
Rec V Date: 03/02/2021
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Symptoms: Pneumonia; A spontaneous report was received from a consumer concerning his mother, a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia. The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter. On 19 Jan 2021, approximately five days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient developed a cough. The patient's temperature was recorded at 101 degrees Fahrenheit. The patient went to doctor. She was fatigued and coughing blood and was diagnosed with pneumonia. Treatment included azithromycin, and the patient seemed to improve. On 05 Feb 2021, the patient developed a temperature of 101?F, coughed up blood and was very fatigued. She was diagnosed with pneumonia. Treatment for the event included levofloxacin. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, pneumonia, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of pneumonia, a causal relationship cannot be excluded. Patient's elderly age and medical history of COPD are considered a risk factors.

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Current Illness: COPD

ID: 1066538
Sex: M
Age:
State: OH

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Rec V Date: 03/02/2021
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Symptoms: organs shut down after vaccine; A spontaneous report was received from a female consumer via social media regarding her father, unknown age, who was administered Moderna Covid-19 Vaccine and have experienced multiple organ failure. The patient's medical history was not provided. His concomitants were not provided. On an unspecified date, prior to onset of symptoms, the patient received their a planned doses of mRNA-1273 (Lot Number: unknown) unknown route of administration. It is not known whether patient received first dose or 2nd dose of vaccine. On an unknown date the patient experienced shut down of multiple organs. It was noted that the doctors said, there was no concrete proof that its due to vaccine. But according to her, the patient was fine till he had the vaccine. Treatment details were not provided. Doctors talked about do not resuscitate orders with her. Action taken with the vaccine is unknown. The outcome of the event multiple organ failure is unknown at the time of report.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Multiorgan failure after receiving mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Due to lack of contact details, no follow-up information is expected.

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Current Illness:

ID: 1066539
Sex: F
Age:
State: VA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 03/02/2021
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Symptoms: Received the vaccine subcutaneously; Received vaccine a little lower in the arm than the deltoid muscle; A spontaneous report was received from Healthcare Professional concerning a 40-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle The patient's medical history was not provided. Concomitant medications were not reported. On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) subcutaneously in the arm for prophylaxis of COVID-19 infection On 25 Jan 2021, the patient experienced received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle was resolved on 25 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate route of vaccine administration and vaccine administered at inappropriate site for mRNA-1273 (Batch Number: 039K20A) with no associated AEs.

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Current Illness:

ID: 1066540
Sex: F
Age:
State: MI

Vax Date: 01/11/2021
Onset Date: 01/27/2021
Rec V Date: 03/02/2021
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Symptoms: felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown. Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: CYMBALTA

Current Illness:

ID: 1066541
Sex: M
Age:
State: IA

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Rec V Date: 03/02/2021
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Symptoms: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); This literature case was received on 22-Feb-2021, concerning 46-year old, male patient. This short study was conducted at the neuromuscular clinic from 2001 to 2005. The patient had no relevant medical history. The patient was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP), did not have any acute illness, systemic infections, diabetes mellitus, history of alcohol abuse, or exposure any known neurotoxins, and there was no family history of neuropathy. The patient's concomitant medications were not reported. On an unknown date, the patient was vaccinated influenza virus vaccine polyvalent (brand not specified; dose, anatomical location, indication and route of administration: not reported). The batch number was not reported. On an unspecified date, seven days after receiving influenza virus vaccine polyvalent, the patient experienced sensation of burning, tingling, and itching over the trunk. The patient underwent detailed history, general and neurological examinations, electrodiagnostic and laboratory studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, venereal disease research laboratory (VDRL), serum immune fixation, thyroid studies, glucose and HbA1C, and magnetic resonance imaging (MRI) of the brain and spine. On an unspecified date, over the next ten days, the patient developed difficulty chewing, bilateral facial weakness and diplopia, along with tingling and numbness in feet and hands, mild weakness in limbs, and gait difficulty. All tendon reflexes were absent, and sensations were normal. The cerebral spinal fluid (CSF) analysis revealed elevated protein (142 mg/dl) with two lymphocytes and normal glucose and cell count. Other laboratory and imaging studies were normal. Electrodiagnostic studies were unremarkable except for mild impersistence of median nerve F waves (four of ten) with normal latencies. Needle electromyogram (EMG) testing of distal lower extremity muscles was unremarkable. Blink reflex showed absent R1 and R2 responses bilaterally and normal response with direct facial stimulation, suggesting a proximal conduction block. Cranial magnetic resonance imaging (MRI) showed subtle enhancement of facial nerves. On an unspecified date, he was treated with a 5-day course of immunoglobulin (IVIG) at a dose of 0.4 g/kg per day. On an unspecified date, the patient improved. On an unspecified date, four weeks later, the patient noted increasing numbness in toes and hands as well as increasing weakness in ankles with decreased balance and gait difficulty. Examination showed weakness with grade four medical research council (MRC) strength in intrinsic hand muscles, hip flexors, and ankle dorsiflexion. Muscle stretch reflexes were diminished in the arms and absent at knees and ankles. Vibration and pin sensation were diminished in feet with preserved proprioception. Electrodiagnostic findings for median motor were: distal motor latency (DL) (ms): 5.3, amplitude (amp): 3.5, conduction velocity (CV) (m/s): 34.21 and F wave latency (ms): 59; for peroneal motor: right (rt): DL (ms): 7.5, amp: 0.8, CV (m/s): 41.22 and F wave latency (ms): No response (NR), left (lt): DL (ms): 6.4, amp: 1.1, CV (m/s): 30.42 and F wave latency (ms): NR; for tibial motor: rt: DL (ms): 6.6, Amp: 3.7, CV (m/s): 34, F wave latency (ms): 84, lt: DL (ms): 5.8, amp: 5.6, CV (m/s): 30 and F wave latency (ms): 78; and for ulnar motor: DL (ms): 3.8, amp: 8.6, CV (m/s): 48, 43, 60, F wave latency (ms): 38. Sural amplitude for lt was 13 ?V and rt: 11 ?V, median sensory amplitude and ulnar sensory amplitude were: NR. Electrodiagnostic studies showed widespread abnormalities, indicating a demyelinating polyneuropathy. Median and ulnar sensory potentials were absent, and sural sensory potentials were preserved. On an unspecified date, the patient was treated with intravenous Gammaglobulin (immunoglobulin g human) (IVIG) at a dose of 1 g/kg monthly for four months. On an unspecified date, the patient improved promptly. On an unspecified date, he experienced another relapse, which responded to pulse intravenous methylprednisolone at a dose of 1000 mg per week (mg/wk) and developed gastrointestinal side effects. Thereafter, he was treated with monthly immunoglobulin (IVIG), and oral Mycophenolate (mycophenolate mofetil) at a dose of 1 g two times a day (bid). On an unspecified date, at the 36-month follow-up, the patient showed no deficit. He had not required IVIG for one year and remained free of relapses. At the time of initial reporting, the patient recovered from event. The reporter assessed the event as related to influenza virus vaccine polyvalent. Physician reported that the patient who was otherwise healthy, developed CIDP with rapid onset in close proximity to influenza vaccination, suggesting a plausible relationship between the immunization and the induction of CIDP, however the plausible relationship was not clear. In conclusion, the relationship between immunization, particularly influenza vaccination, and the development of acquired demyelinating neuropathies has been discussed in the literature, mostly in the context of Guillain-Barre syndrome (GBS). Although the concern that CIDP might follow influenza vaccination similar to Guillain-Barre syndrome (GBS) might seem intuitive, there were no clearly documented cases in the literature of CIDP with abrupt onset within a few days after influenza vaccination. Our patient, who was otherwise healthy, developed CIDP with rapid onset in close proximity to influenza vaccination, suggesting a plausible relationship between the immunization and the induction of CIDP. Rapid onset resembling GBS occurs in about 15 percent to 20 percent of cases of CIDP. It was possible that antecedent events such as immunization are more likely in such patients, but that has not been systematically evaluated. In contrast to GBS, which was a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune-mediated disorder such as CIDP is not known. This case is linked to cases 202101474 and 202101475 (the same literature article). Company comment: A 46-year-old male patient developed chronic inflammatory demyelinating polyradiculoneuropathy after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP) and did not have any acute illness or systemic infections, diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins. As reported, the patient had multiple relapses with varying diagnostic findings. Information regarding the concomitant medications have not been provided. Based on plausible time relationship, causality for the reported event cannot be totally excluded and is assessed as possibly related.; Reporter's Comments: Physician reported that the patient who was otherwise healthy, developed CIDP with rapid onset in close proximity to influenza vaccination, suggesting a plausible relationship between the immunization and the induction of CIDP, however the plausible relationship was not clear.; Sender's Comments: A 46-year-old male patient developed chronic inflammatory demyelinating polyradiculoneuropathy after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP) and did not have any acute illness or systemic infections, diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins. As reported, the patient had multiple relapses with varying diagnostic findings. Information regarding the concomitant medications have not been provided. Based on plausible time relationship, causality for the reported event cannot be totally excluded and is assessed as possibly related.

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ID: 1066542
Sex: M
Age:
State: IA

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Rec V Date: 03/02/2021
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Symptoms: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); This literature case was received on 22-Feb-2021 and concerned an 89-year-old male patient. The patient had no relevant medical history. He was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP) and did not have any acute illness or systemic infections, diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins. The patient's concomitant medications were not reported. There was no family history of neuropathy. On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported. On an unspecified date, two days after receiving influenza virus vaccine polyvalent, the patient developed tingling in the hands, followed by progressive weakness, which progressed over two weeks, in his arms and legs. On an unknown date, the patient started five-day course treatment with intravenous immune globulin (IVIG) over four weeks. On an unknown date, patient improved. On an unspecified date, a month later, the patient experienced more gradual worsening of weakness over six weeks. The patient was unable to walk or stand, even with support. On an unknown date, the patient underwent detailed history, general and neurological examinations, electrodiagnostic and laboratory studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, venereal disease research laboratory (VDRL), serum immune fixation, thyroid studies, glucose and HbA1C, and magnetic resonance imaging (MRI) of the brain and spine. Examination showed marked weakness in proximal and distal muscles of all extremities, with absent muscle stretch reflexes. The patient's tendon reflexes were all absent. Vibration was diminished in the toes, and other sensations were intact. Electrodiagnostic findings for median motor were: right (rt) distal motor latency (DL) (ms): 9.3, rt: amplitude (Amp) (mV): 1.6, rt: conduction velocity (CV) (m/s): 24, 26 and rt: F wave latency (ms): 54; for peroneal motor: rt: DL (ms): 6.7, rt: Amp (mV): 0.4, rt: CV (m/s): 31, 31 and rt: F wave latency (ms): No response (NR); for tibial motor: rt: DL (ms): 8.3, rt: Amp (mV): 0.7, rt: CV (m/s): 26, rt: F wave latency (ms): NR and for ulnar motor: rt: DL (ms): 4.3, rt: Amp (mV): 3.5, rt: (CV) (m/s): 43, 37, 43, rt: F wave latency (ms): 47. Sural amplitude for left (lt) and rt: NR, median sensory amplitude was: NR and ulnar sensory amplitude was 2.6 mV. Needle Electromyography (EMG) showed fibrillation potentials and loss of motor unit potentials in the distal upper and lower extremity muscles. Electrodiagnostic studies showed widespread abnormalities, indicating a demyelinating polyneuropathy. Many nerves showed findings suggestive of primary demyelination namely temporal dispersion or conduction block, marked reduction of conduction velocity, prolongation or absent F waves, prolonged distal motor latencies, and met the commonly accepted criteria for diagnosis of CIDP. The cerebral spinal fluid (CSF) analysis revealed elevated protein (127,3 mg/dl), with normal glucose and cell count. Other laboratory and imaging studies were normal. On an unknown date, the patient was treated monthly with IVIG at dose of 1 g/kg and oral Mycophenalate (mycophenolate mofetil) at dose of 1000 mg, twice a day (bid). On an unknown date, after six months IVIG was discontinued. On an unspecified date, at the 16-month follow-up, the patient showed normal gait and only mild weakness of intrinsic hand muscles (grade 4 Medical Research Council (MRC)). At the time of initial reporting, the patient was recovering from event. The relationship between immunization, particularly influenza vaccination, and the development of acquired demyelinating neuropathies has been discussed in the literature, mostly in the context of Guillain-Barre syndrome (GBS). The plausible relationship between CIDP and vaccination was less clear than between GBS and vaccination. Patients, who were otherwise healthy, developed CIDP with rapid onset in close proximity to influenza vaccination, suggesting a plausible relationship between the immunization and the induction of CIDP. Rapid onset resembling GBS occurs in about 15 percent to 20 percent of cases of CIDP. It was possible that antecedent events such as immunization were more likely in such patients, but that had not been systematically evaluated. In contrast to GBS, which was a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune-mediated disorder such as CIDP was not known. The event of chronic inflammatory demyelinating polyneuropathy was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. This case is linked to cases 202101473 and 202101475 (the same literature article). Company comment: A 89-year-old male patient developed chronic inflammatory demyelinating polyradiculoneuropathy after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP) and did not have any acute illness or systemic infections, diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins. As reported, electrodiagnostic studies showed widespread abnormalities, indicating a demyelinating polyneuropathy. Information regarding the concomitant medications have not been provided. Based on plausible time relationship, causality for the reported event cannot be totally excluded and is assessed as possibly related.; Reporter's Comments: The patient, who were otherwise healthy, developed CIDP with rapid onset in close proximity to influenza vaccination, suggesting a plausible relationship between the immunization and the induction of CIDP.; Sender's Comments: A 89-year-old male patient developed chronic inflammatory demyelinating polyradiculoneuropathy after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP) and did not have any acute illness or systemic infections, diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins. As reported, electrodiagnostic studies showed widespread abnormalities, indicating a demyelinating polyneuropathy. Information regarding the concomitant medications have not been provided. Based on plausible time relationship, causality for the reported event cannot be totally excluded and is assessed as possibly related.

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ID: 1066543
Sex: F
Age:
State: IA

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Symptoms: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); This literature case was received on 22-Feb-2021 and concerned an 84-year-old, female patient. The aim of this study was to describe three patients who developed chronic inflammatory demyelinating polyneuropathy (CIDP) with rapid onset in close proximity to influenza vaccination followed by relapsing or chronic course. Patients were evaluated at the neuromuscular clinic from 2001 to 2005. The patients underwent detailed history, general and neurological examinations, electrodiagnostic and laboratory studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, venereal disease research laboratory (VDRL), serum immune fixation, thyroid studies, glucose and HbA1C, and magnetic resonance imaging (MRI) of the brain and spine. The patient had no relevant medical history. The patient was in good health and had no acute illness or systemic infections. The patient had no diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins and had no family history of neuropathy. The patient's concomitant medications were not reported. On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for influenza vaccination. The batch number was not reported. On an unknown date, 21 days after receiving influenza virus vaccine polyvalent, the patient experienced severe pain in a band like distribution in the mid thoracic region. On an unknown date, four days later, the patient experienced progressive weakness and numbness which progressed over six weeks, in her legs and hands. The patient was able to take a few steps with a walker, and she had marked weakness in proximal and distal muscles of upper and lower extremities. Muscle stretch reflexes were absent in the legs and diminished in the arms. Vibration was absent in the feet, but proprioception and pin sensation were intact. Gait was broad based and ataxic. On an unknown date, the patient started a five-day course of intravenous immunoglobulin (IVIG), but did not improve. The patient was then treated with weekly pulse oral prednisone starting at dose of 150 mg/wk for two months followed by a slow taper to 20 mg/wk. On unknown date, CSF protein was elevated (136 mg/dl), with normal glucose and cell count. Other laboratory and imaging studies were normal. Electrodiagnostic studies showed evidence of demyelinating polyneuropathy. These values indicated primary demyelination: sural amplitude showed no response, peroneal motor distal latency (DL) was 11 ms (right) and 12.2 ms (left), amplitude (AMP) was 0.5 mV (right) and 0.3 mV (left), and conduction velocity (CV) in different segments revealed 21, 22 m/s (right) and 22, 23 m/s (left). Tibial motor DL was 10.7ms (right) and 9.9 ms (left), AMP was 2 mV (right) and 2.3 mV (left), and CV in different segments was 27 m/s (right) and 34 m/s (left) while F wave latency showed no response (NP) (right) and 120 ms (left). Ulnar motor DL revealed 5.1 ms (right and left), amplitude was 5.1 mV (right) and 3.8 mV (left), CV was 37, 34 and 30 m/s (right) and 35, 36 and 38 (left), while F wave latency was 50 (right) and 48 (left). Many nerves showed findings suggestive of primary demyelination, namely temporal dispersion or conduction block, marked reduction of conduction velocity, prolongation or absent F waves, prolonged distal motor latencies, and met the commonly accepted criteria for diagnosis of CIDP. This patient had second relapse and progressive course. On an unknown date, at 14-months follow-up, the patient was able to ambulate without assistance, and she has mild weakness (grade 4 MRC) in deltoid, intrinsic hand muscles, and hip flexion. Reflexes remain absent in the lower extremities. On an unknown date, at 16-months follow-up, the patient was able to ambulate independently and had mild weakness in arms. At the time of initial reporting, the patient was recovering from the event. The author assessed the event as related to influenza virus vaccine polyvalent. The patient who was otherwise healthy, developed CIDP with rapid onset in close proximity to influenza vaccination, suggesting a plausible relationship between the immunization and the induction of CIDP. The event of CIDP was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. The relationship between immunization, particularly influenza vaccination, and the development of acquired demyelinating neuropathies had been discussed in the literature, mostly in the context of Guillain-Barre syndrome (GBS). The plausible relationship between CIDP and vaccination was less clear than between GBS and vaccination. Rapid onset resembling GBS occurs in about 15 percent to 20 percent of cases of CIDP. It was possible that antecedent events such as immunization were more likely in such patients, but that has not been systematically evaluated. In contrast to GBS, which was a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune-mediated disorder such as CIDP was not known. This case is linked to cases 202101473 and 202101474 (the same literature article). Company comment: A 84-year-old female patient developed chronic inflammatory demyelinating polyradiculoneuropathy after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP) and did not have any acute illness or systemic infections, diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins. As reported, the patient had multiple relapses with varying diagnostic findings. More information regarding the concomitant medications. is needed. Based on plausible time relationship, causality for the reported event cannot be totally excluded and is assessed as possibly related.; Reporter's Comments: The patient who was otherwise healthy, developed CIDP with rapid onset in close proximity to influenza vaccination, suggesting a plausible relationship between the immunization and the induction of CIDP.; Sender's Comments: A 84-year-old female patient developed chronic inflammatory demyelinating polyradiculoneuropathy after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient was in good health prior to the onset of chronic inflammatory demyelinating polyneuropathy (CIDP) and did not have any acute illness or systemic infections, diabetes mellitus, history of alcohol abuse, or exposure to any known neurotoxins. As reported, the patient had multiple relapses with varying diagnostic findings. More information regarding the concomitant medications. is needed. Based on plausible time relationship, causality for the reported event cannot be totally excluded and is assessed as possibly related.

Other Meds:

Current Illness:

ID: 1066544
Sex: M
Age: 80
State: NC

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 03/02/2021
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Allergies: None.

Symptom List:

Symptoms: Had shortness of breath, chills, and fever up to 102 for the first day and half. On Sunday it came back to normal finally. Night sweats that are still continuing. Just during the day and get hot flashes. Flushing, upper body clamminess and then goes away and then has chills. His breathing has improved but is still not real steady on his feet. He is about 80-85% on his balance, 95% on his breathing. His biggest problem at this point is the hot flashes and the chills. He also has had loss of appetite and has had weight loss.

Other Meds: Simvastatin, Chlorathiodone, Creon, Carvedilol, Lisinopril, Warfarin, multivitamin, Loperamide HCI, CoQ10, Tamsolusin, glucosamine chondroitin, vitamin D3, zinc.

Current Illness: None.

ID: 1066545
Sex: M
Age: 68
State: MI

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 03/02/2021
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Allergies: iodine dye

Symptom List:

Symptoms: lower abdominal pain, diaphoresis, pale, nauseated, lightheaded, dizzy, bradycardic

Other Meds: unknown

Current Illness: unknown

ID: 1066546
Sex: F
Age: 67
State: NC

Vax Date: 02/15/2021
Onset Date: 02/21/2021
Rec V Date: 03/02/2021
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Allergies: NKDA , no food allergies

Symptom List:

Symptoms: Developed Bells Palsy on 02/21/2021. Presented to hospital 02/22/2021. Treated with Prednisone and Valacyclovir Is improved

Other Meds: Metformin 1000 po bid Simvastatin 40 mg nightly

Current Illness: none

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm