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
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 0918916
Sex: M
Age: 59
State: WI

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 01/04/2021
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: SMX/TMP

Symptom List: Dysphagia, Epiglottitis

Symptoms: Patient received vaccine that may not be fully effective due to room temperature storage for more than 12 hours

Other Meds:

Current Illness:

ID: 0918917
Sex: F
Age: 35
State: CA

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: ? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to EOHD since we were so busy. ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER. She was recovering and doing fine. Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.

Other Meds:

Current Illness:

ID: 0918918
Sex: F
Age: 90
State: NY

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Chills, Vomiting. Malaise

Other Meds:

Current Illness:

ID: 0918919
Sex: M
Age: 52
State: OK

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Naproxen - Stevens Johnsons Syndrome

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization (12.17.20). Patient had "extreme" fatigue and weakness for 2 weeks. Went to urgent care on 12.28.2020, no medications or treatment given. Resolved as of 1.4.21 with continued "slight" weakness. Patient also reports to have lost a considerable amount of weight.

Other Meds: None

Current Illness: None

ID: 0918920
Sex: F
Age: 44
State: CA

Vax Date: 12/31/2020
Onset Date: 01/03/2021
Rec V Date: 01/04/2021
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: Muscle pain all over, fatigue and hot/cold flashes. Patient also reports feeling very thirsty.

Other Meds:

Current Illness:

ID: 0918921
Sex: F
Age: 49
State: WY

Vax Date: 12/31/2020
Onset Date: 01/04/2021
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Imitrex, inapsine, demerol

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

Symptoms: Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).

Other Meds: Effexor, levothyroxine, atorvastatin, calcium w vitamin D, turmeric, pomegranate, melatonin

Current Illness: none

ID: 0918922
Sex: F
Age: 52
State: TX

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/04/2021
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: sulfa, pcn

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Half dollar size knot with rash down my arm. Painful to raise my arm. Took 2 Benadryl saturday afternoon and 2 at night before bed ,by morning the knot was pea size and rash was gone

Other Meds: synthroid, metropol, prozac, Lipitor

Current Illness: flu

ID: 0918923
Sex: M
Age: 75
State: NY

Vax Date: 01/02/2021
Onset Date: 01/03/2021
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Patient had multiple episodes of vomiting but has a history of dysphagia, patient also reported generalized weakness in bilateral lower extremities. Was sent to the ER and discharged

Other Meds:

Current Illness:

ID: 0918924
Sex: F
Age: 35
State: VT

Vax Date: 12/24/2020
Onset Date: 12/31/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Penicillin, Sulfa. Have reactions to raw fruits and vegetables including apples, peaches, pears, pears, snap peas, almonds (w/ skin)

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: red hot rash appeared 1 week after received vaccine. it was slightly itchy. Rash grew slightly on 2nd day but decreased in redness, still hot. Third day size and redness decreased as well as temperature. 4th day gone.

Other Meds: Gummy Multivitamin

Current Illness: none

ID: 0918925
Sex: F
Age: 0
State: WI

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

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

Lab Data:

Allergies: unable to determine

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Patient had some dizziness and flushing post vaccine administration, but she declined calling the rapid response team. This resolved within 5 minutes without intervention. Closely monitored for 30 minutes.

Other Meds: none per pt

Current Illness: denies

ID: 0918926
Sex: F
Age: 40
State: NY

Vax Date: 12/19/2020
Onset Date: 12/29/2020
Rec V Date: 01/04/2021
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: On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of dexterity. It improved somewhat over the next 45 minutes, but I continue to have loss of sensation in all 10 fingertips, worse in both thumb and 5th digits.

Other Meds: Magnesium, Vit D, Acetyl L-Carnitine, Probiotic, Flonase

Current Illness: None

ID: 0918927
Sex: F
Age: 39
State: KS

Vax Date: 12/15/2020
Onset Date: 12/16/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Nausea, chills, arthralgia/myalgia, low-grade fever: all symptoms began 16 hours after vaccine and subsided within 24 hours of vaccine.

Other Meds: Synthroid Adderall XR Vitamin D2

Current Illness:

ID: 0918928
Sex: F
Age: 64
State: OH

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/04/2021
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, quinolones

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

Symptoms: Anxiety attack lasting 2 hours,. Took some benadryl and wellbutrin. Within 40 minutes calmed down enough, until the next day started feeling shaky and anxious again..called Dr. at home. She says to take my wellbutrin in the morning as well as my evening dose and benedryl every 4 hours. Has been good since then.

Other Meds: Ability 5 mg daily, wellbutrin 150 mg daily

Current Illness: None

ID: 0918929
Sex: F
Age: 21
State: IL

Vax Date: 12/26/2020
Onset Date: 12/27/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Sulfa drugs

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

Symptoms: Fever greater than 100 degrees F, full body muscle aches, chills, sore throat, tender armpit (left)- 12/27/2020 (all day) Itchy, blanched, swollen, hard, warm patch on left arm 4.5" x 3" with surrounding redness and tender armpit- 01/02/2021- present

Other Meds: Sprintec (birth control), Methimazole, Ferrous sulfate

Current Illness: N/A

ID: 0918930
Sex: M
Age: 1
State: IL

Vax Date: 12/07/2020
Onset Date: 12/07/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Minimum interval from last dose not met

Other Meds:

Current Illness:

ID: 0918931
Sex: F
Age: 59
State: CA

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 01/04/2021
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: Contrast dye

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

Symptoms: Patient received the covid vaccine on 12/30/2020. Tolerated the vaccine without problem. c/o new onset of "stomach pain" at the RLQ. Unable to walk starting on Jan 3rd. Pain persists today. Denies fever, HA, Dizziness, cough, nausea, vomiting, diarrhea, or constipation. She has reached out to her rheumatologist. She noticed the pain occurred after she self administered the Taltz injection on 12/31/2020. She is concerned about the drug-to-drug interactions with the vaccine. Covid test on 12/23/2020 was negative.

Other Meds: MTX, levothyroxine, Taltz inj, folic acid, Lisinopril

Current Illness:

ID: 0918932
Sex: F
Age: 51
State: KS

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/04/2021
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: Floroquinolines Dilaudid Steroids Tramadol

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

Symptoms: My arm was so sore I could not hardly move it, starting approx. 6 hours after injection. Now 5 days after injection still quite sore. Entire upper arm, approx. 7"x4" area erythema and hot to touch (even through clothing). Redness started a couple hours after injection. Now 5 days after vaccine red area is approx. 3"x3". At injection site, approx. 1"x1" hard bump that is still present 5 days after vaccine Area of upper arm where injection given, severe itching, which continues now 5 days after vaccine. Approx 9 hours after injection and continuing for approx. 36 hours, body aches and joint pain. I took Tylenol and Benadryl for 48 hours after vaccine reaction first noted.

Other Meds: Gabepentin Tizanidine Phenergan Prilosec OTC Meloxicam Isosorbide

Current Illness: Non

ID: 0918933
Sex: F
Age: 50
State: WI

Vax Date: 12/26/2020
Onset Date: 12/31/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Patient received a dose of vaccine that may be less than fully effective due to storage at room temperature for more than 12 hours

Other Meds:

Current Illness:

ID: 0918934
Sex: F
Age: 40
State: NY

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Woke up during the night (12/24) with a sore throat, felt like it was closing and called 911. Did not go to ER. took Benadryl with relief. Injection site hot with an extremely sore arm the first day which is better now. Fatigue, achy all over persists taking tylenol and ibuprofen for symptoms.

Other Meds:

Current Illness:

ID: 0918935
Sex: F
Age: 33
State: NE

Vax Date: 01/02/2021
Onset Date: 01/03/2021
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Pineapple

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

Symptoms: Rash on chest, neck and arms Nausea, loss of appetite Severe Headache Extreme Fatigue

Other Meds: Prenatal Vitamin

Current Illness: None

ID: 0918936
Sex: F
Age: 54
State: TN

Vax Date: 12/23/2020
Onset Date: 01/01/2021
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: none

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

Symptoms: Injection site became very red, swollen, hot to the touch and soreness returned 10 days after vaccination. Called my healthcare provider and he prescribed Cephalexin 500 MG to be taken three times a day for seven days. Three days after starting antibiotic treatment, redness and swelling were gone along with the fever in the arm. Healthcare provider suggested I not take the second dose. I would like an opinion from your facility.

Other Meds: clonazapam

Current Illness: none

ID: 0918937
Sex: F
Age: 30
State: OH

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Unevaluable event

Symptoms: Pain at the injection site

Other Meds: Prenatal Iron Vitamin D

Current Illness: None

ID: 0918938
Sex: F
Age: 28
State: AZ

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/04/2021
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: amoxicillin

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

Symptoms: pt began to feel tingling in her left arm and her throat. she felt tightness in the throat and voice was hoarse. she felt ligh headed like she might pass out but did not pass out. she felt chest discomfort with deep breath.

Other Meds: depo shot

Current Illness: none

ID: 0918939
Sex: F
Age: 21
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Prozac, nickel

Symptom List: Injection site pain, Pain

Symptoms: Low grade fever, chills, head ache, body aches

Other Meds: Zoloft, Microgestin

Current Illness: None

ID: 0918940
Sex: F
Age: 33
State: PA

Vax Date: 12/28/2020
Onset Date: 01/02/2021
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: no known allergies

Symptom List: Injection site pain, Menorrhagia

Symptoms: I am currently experiencing a swollen lymphnode in my left armpit which is the same arm that I received the vaccine in. This first presented around 11:00pm on Saturday 01/02/2021. I received my first dose of the moderna covid-19 vaccine on 12/28/2020. I did look on Moderna's website for further reaction information and it states that 4% of their test group reported this same symptom 5 to 7 days after first injection.

Other Meds: Junel birthcontrol

Current Illness: no illness

ID: 0918941
Sex: F
Age: 43
State: NY

Vax Date: 12/19/2020
Onset Date: 12/25/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.

Other Meds:

Current Illness:

ID: 0918942
Sex: F
Age: 30
State: NY

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: First day, shooting pain up the back of the arm. Next day noticed a firm lump 2" from injection site, tricep area with redness and swelling, tenderness and pain all at inj. site. Marked for size and by 12/26 the lump, redness, swelling had increased in size. Tylenol with no relief, applied heat to lump made it worse. Took Benadryl x 3 doses and symptoms are much improved. Headache on 12/25-12/26, Fatigue x 3 days, muscle pain in shoulders/neck.

Other Meds:

Current Illness:

ID: 0918950
Sex: F
Age: 41
State: LA

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.

Other Meds:

Current Illness:

ID: 0918952
Sex: F
Age: 43
State: LA

Vax Date: 12/23/2020
Onset Date: 12/27/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.

Other Meds:

Current Illness:

ID: 0918953
Sex: F
Age: 56
State: LA

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.

Other Meds:

Current Illness:

ID: 0918964
Sex: F
Age: 68
State: FL

Vax Date: 11/07/2020
Onset Date: 11/01/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: lost peripheral vision; vascular spasms which could be impacting blood flow to the optic nerve; Loss of vision in both eyes for approximately 10 seconds; Pinpoint vision with straight lines / narrowing of vision like pinpoint straight black lines or black straws then everything went black; 3 or 4 episodes of memory loss; ice cold sensation around her head; head felt strange; low voltage electricity going through her head / felt like a knife stabbing on the left side of her head and then on the right side of the head; chickenpox can lie dormant in the termporal lobe of the brand / Shingrix may have disturbed that.; headache; Body aches; Sore, aching arm; This case was reported by a nurse via call center representative and described the occurrence of loss of vision in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles in the early 2000s, between 2004-2006.). Previously administered products included Zostavax. On 7th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling cold, feeling abnormal, head discomfort and chickenpox. On 8th November 2020, the patient experienced memory loss. In November 2020, the patient experienced headache and general body pain. On 11th December 2020, the patient experienced loss of vision (serious criteria GSK medically significant) and abnormal vision. On an unknown date, the patient experienced peripheral vision defective and spasms. On 11th December 2020, the outcome of the loss of vision was recovered/resolved. On an unknown date, the outcome of the pain in arm, general body pain and abnormal vision were recovered/resolved and the outcome of the headache and memory loss were not recovered/not resolved and the outcome of the feeling cold, feeling abnormal, peripheral vision defective, spasms, head discomfort and chickenpox were unknown. The reporter considered the loss of vision, pain in arm, headache, general body pain, memory loss and abnormal vision to be related to Shingrix. It was unknown if the reporter considered the feeling cold, feeling abnormal, peripheral vision defective, spasms, head discomfort and chickenpox to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Patient had shingles in the early 2000s, between 2004-2006. Patient received Zostavax in 2011. It was reported that patient received the second dose of Shingrix on 7th November 2020 and experienced sore, aching arm (occurred the same day and lasted approximately 3-4 days),severe headache (began day second dose received on 11/7/2020 and was ongoing), body aches (began day of second dose, on 11/7/2020), 3 or 4 episodes of memory loss(began the day after receiving the second dose, on 11/8/2020. Last occurrence on 12/20/2020) Patient also experienced pinpoint vision with straight lines (occurred a week prior to 12/18/20), and loss of vision in both eyes for approximately 10 seconds (occurred a week prior to 12/18/20). HCP suggested that symptoms were related to Shingrix. It was also stated that patient experienced vision loss she initially felt like there was a low voltage electricity going through her head.and lost peripheral vision also regarding forward vision, she experienced a narrowing of vision like pinpoint straight black lines or black straws then everything went black,all of this all lasted about 10 seconds in total. Patient also felt heard strange. Patient did some testa like CT scan of her brain with and without contrast dye and it came back negative and had a CT scan with contrast dye of her carotid and it came back negative. She was cleared by Cardiac and she was having an MRI with contrast dye. On 7th November 2020 patient also experienced an ice cold sensation around her head which lasted for maybe a week or less, on same night felt like a knife stabbing on the left side of her head and then on the right side of the head. Physician mentioned she could be having vascular spasms which could be impacting blood flow to the optic nerve and also mentioned that chickenpox can lie dormant in the termporal lobe of the brand and that Shingrix may have disturbed that. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0918965
Sex: F
Age: 16
State: MI

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Penicillin, IV contrast, Amoxicillin

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

Symptoms: Patient received 2nd dose of Bexsero and after she left the building and was at home she began to vomit.

Other Meds:

Current Illness:

ID: 0918966
Sex: F
Age:
State: IL

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was "102 something", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.

Other Meds:

Current Illness: MS

ID: 0918967
Sex: F
Age:
State:

Vax Date: 12/16/2020
Onset Date: 12/17/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day (17Dec2020). She is scheduled to take her second dose on 20Jan2021. The patient wanted to know what Pfizer recommendations are. Outcome of the event was unknown. That information on the lot/batch number has been requested.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination and the event onset.

Other Meds:

Current Illness:

ID: 0918968
Sex: F
Age: 54
State: NY

Vax Date: 12/23/2020
Onset Date: 12/31/2020
Rec V Date: 01/04/2021
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: Ceclor, sulfa, Lorabid, Ultram, parafon forte, honey

Symptom List: Erythema, Pruritus

Symptoms: (L) increased arm soreness, sl. redness resolved after 2 days, Dec 31st swelling redness @ site 1/2 dollar size. progressed to saucer size over weekend of 1/1 - 1/3 Less swelling, increased redness and size

Other Meds: Bisoprolol 2.5 mg po qd, Tricor 145mg po qHs, vit D 2000 IU QD, Protonix 20mg po qd, carafate 1gm po

Current Illness: decreased cold symptoms early in Dec COVIDE

ID: 0918969
Sex: F
Age:
State: IL

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.

Other Meds: VYVANSE; LEXAPRO; BRIVIACT

Current Illness:

ID: 0918970
Sex: F
Age:
State: MA

Vax Date: 12/21/2020
Onset Date:
Rec V Date: 01/04/2021
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: Chills; fever; fatigue; tiredness; nausea; Little bit of vomiting; This case was missing the following minimum criteria: there is unspecified event. Upon receipt of follow-up information on (22Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP reporting for herself. A 51-year-old female patient received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced the following symptoms chills, fever, fatigue, tiredness, nausea, little bit of vomiting, the outcome of all the reported events was unknown. The patient stated that before receiving the vaccine, she was in contact with her husband who discovered to be positive to COVID 19. The patient is now concerned because she does not know if the symptoms she is experiencing are caused by the vaccine or by the illness.

Other Meds:

Current Illness:

ID: 0918971
Sex: M
Age:
State: PA

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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: chills; fever; bodyaches; fatigue; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 24Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ej1685), via intramuscular in left arm on 22Dec2020 14:45 at first single dose, via intramuscular in left arm on 22Dec2020 15:00 at second single dose (pending to clarify), for COVID-19 immunisation. Medical history included COVID-19, high blood pressure (BP) and high cholesterol and myocarditis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. 24 hours after receiving the first vaccine (23Dec2020 16:00), the patient experienced chills fever body aches and fatigue. The events were non-serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered in Dec2020.

Other Meds:

Current Illness:

ID: 0918972
Sex: F
Age:
State:

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 01/04/2021
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: Headache; Fatigue; The patient received BNT162B2 and was lactating; The patient received BNT162B2 and was lactating; This is a spontaneous report from a contactable healthcare professional reporting for herself and her baby. This is the maternal report. A 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EH9899) intramuscular, on 16Dec2020 at 10:00, in right arm, for COVID-19 immunisation. No other vaccine was given within 4 weeks before. The patient was breastfeeding. Allergies to medications, food, or other products: no. The patient had no COVID before vaccination. Concomitant medications included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), vitamin D and calcium. The patient was lactating and on 17Dec2020 her baby seemed to have had an upset stomach, she had trouble sleeping and spit up a few times which was abnormal for her. On 17Dec2020 the patient experienced headache and fatigue which both resolved with lasting effects on an unspecified date in Dec2020. Treatment included paracetamol (TYLENOL). Since the vaccine she had had a headache daily. The events required physician office visit. COVID was not tested after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020511585 baby case

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYR; VITAMIN D [COLECALCIFEROL];

Current Illness: Breast feeding

ID: 0918973
Sex: F
Age: 33
State: ME

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/04/2021
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: nausea and vomited x 1 the morning after receiving the vaccine

Other Meds:

Current Illness:

ID: 0918974
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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: being tested positive; being tested positive; felt very sick; congestion; This is a spontaneous report from a contactable other healthcare professional (patient herself). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt very sick and that's not her normal. The patient felt great after getting the vaccine she hadn't felt that in a while. Today (23Dec2020) the patient had this congestion and 4 -5 people came back positive post covid-19 vaccination on unknown date. All of them sent home after being tested positive. The patient just someone to keep track, she just wanted Pfizer to know. She didn't have any problems, she was working COVID patients. They had a lot new cases. She just didn't feel 100%. The patient wanted to know if it's safe for her to get the second dose after being tested COVID positive post vaccination. The outcome of events was unknown.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the reported events and vaccination with BNT162B2. Additional information regarding therapy vaccination date, lot number and investigation results will aid in comprehensive assessment of the case.

Other Meds:

Current Illness:

ID: 0918975
Sex: F
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she reported on 18Dec2020 got vaccine later that day tested positive; she reported on 18Dec2020 got vaccine later that day tested positive; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 18Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. She reported on 18Dec2020 got vaccine later that day tested positive with outcome of unknown. She asked can she still receive the 2nd dose of the vaccine or should she repeat the vaccination series. The patient underwent lab tests and procedures which included Sars-Cov-2 test: positive on 18Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. 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:

Current Illness:

ID: 0918976
Sex: U
Age:
State: IL

Vax Date: 12/18/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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: received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Device Type: Vial), intramuscularly on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive on 23Dec2020. PharmD asked if it's possible to administer Bamlanivimab to a patient who received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive. Pharmacist mentioned that as Bamlanivimab was an EUA drug, they cannot go outside of the recommendations, and given that no information was available about its use after a dose of the COVID-19 vaccine, it is possible that Bamlanivimab may not be administered. Explained Pfizer MI is unable to provide a direct recommendation, was referred to the patient's Docton for guidance: Before receiving the next dose of the COVID-19 vaccine, and to clarify if Bamlanivimab should be administered. The outcome of events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported tested positive 5 days after COVID-19 vaccine is considered related to the administration of BNT162B2.

Other Meds:

Current Illness:

ID: 0918977
Sex: M
Age:
State: NY

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: PCR test positive for COVID-19 but no signs of COVID-19; PCR test positive for COVID-19 but no signs of COVID-19; This is a spontaneous report from a contactable physician reporting for himself. A 70-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 17Dec2020 at 09:00 AM, at single dose, for Covid-19 immunisation. Medical history included hypertension, high cholesterol, benign prostatic hyperplasia, drug allergy and food allergy all from unknown date and unknown if ongoing. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient received unknown medications within 2 weeks of vaccination. Historical vaccine included typhoid vaccine (unknown trade name) on unknown date and the patient experienced drug allergy. The day after vaccination with bnt162b2, on 18Dec2020 at 04:00 PM, the patient experienced PCR test positive for COVID-19 but no signs of COVID-19. The patient did not receive any treatment as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included: COVID-19 PCR test positive (18Dec2020), nasal swab positive (18Dec2020). Outcome of the event was unknown. The information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 PCR test positive and suspected lack of efficacy due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. 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:

Current Illness:

ID: 0918978
Sex: M
Age:
State: NC

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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: Harder to breathe; Heaviness on Chest; Hot Feeling in back of throat behind nose and down throat; Hot Feeling in back of throat behind nose and down throat; This is a spontaneous report from a contactable health professional, the patient. A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 23Dec2020 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported; however, there were no other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Dec2020 at 15:00, the patient experienced a hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe. The patient was treated for the hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe with 50 mg of oral diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe were resolved on Dec2020. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0918979
Sex: M
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: 8min after injection, felt dry mouth; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; This is a spontaneous report from a non-contactable Physician (Patient). A 36-year-old male Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at 12:45 PM at single dose (vaccine location was Left arm) via unknown route of administration for unknown indication. Medical history included Psoriasis and concomitant medications were not reported. There were no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 8min after injection on 18Dec2020, Patient felt dry mouth, BP was checked, SBP was 160s, Heart rate (HR) 110s. He Felt a little dizzy and some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline). Patient received Benadryl 25mg IV as treatment. Patient did have covid prior vaccination and did not have covid tested post vaccination. Patient went to Emergency Room Visit. The outcome of the events was recovered on 18Dec2020. No follow-up attempts are possible. Information about lot/batch number could not be requested.

Other Meds:

Current Illness:

ID: 0918980
Sex: M
Age:
State: AL

Vax Date: 12/19/2020
Onset Date: 12/25/2020
Rec V Date: 01/04/2021
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: guillain barre syndrome; stroke; left thigh burning; Left b/l gluteal burning/bilateral gluteal burning; paresthesia; mid back burning; right side burning / right thigh burning; b/l hand numbness/bilateral hand numbness; left facial numbness; b/l foot numbness/bilateral foot numbness; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 19Dec2020 at single dose for prevention. Medical history included none. There were no concomitant medications. Caller states, he received the covid vaccine 19Dec2020 and on 25Dec2020 he was experiencing left facial numbness, b/l foot numbness, b/l hand numbness on 26Dec2020, right side burning on 28Dec2020, Today (29Dec2020) he has had left thigh burning, and Left b/l gluteal burning and paresthesia. No motor issues and no tendon issues, all intact. Also had mid back burning on 28Dec2020 that comes and goes. He has heard that there is a described neuropathy with the virus and/or with the vaccine and wants more information on that. Curious if anyone has anything similar? and makes mention of possible Gillian Barre Syndrome. States that he has had a potential reaction. He had his dose on 19Dec2020. On 25Dec2020 he developed left facial numbness, then later that day he developed bilateral foot numbness. On 26Dec2020, he developed bilateral hand numbness, on 28Dec2020 he developed right thigh burning, and today (29Dec2020) he has developed left thigh burning, and bilateral gluteal burning and paresthesia. States that he has been kind of freaking out about it. He doesn't have any motor issues. States that he heard that there is a described neuropathy with the virus, but not with the vaccine, is that true? The left facial numbness resolved on either 26Dec2020 or 27Dec2020. States that the symptoms were concerning because it could have been a stroke. States his symptoms were moderate. States that due to the bilateral foot and hand numbness, he had a LP, brain and spine MRI, and blood work done on 26Dec2020. All came back completely normal. When asked about causality, caller states that it makes the most sense for his symptoms to be caused by the vaccine due to his age and the fact that all his testing was completely normal. Reporter seriousness for left facial numbness, bilateral foot numbness, bilateral hand numbness, right thigh burning, left thigh burning and bilateral gluteal burning and paresthesia: Medically significant. The outcome of the event left facial numbness was recovered in Dec2020. The outcome of the events guillain barre syndrome, stroke and mid back burning was unknown. The outcome of the other events was not recovered.; Sender's Comments: Based on the temporal relationship the association between the reported serious adverse events with BNT162b2 can not be fully excluded. 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:

Current Illness:

ID: 0918981
Sex: F
Age:
State:

Vax Date: 10/12/2020
Onset Date: 10/12/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Vaccine exposure during pregnancy; Partial placenta previa; This observational study case, received on 30-Oct-2020 from other health professional and concerned a 28-year-old, female, pregnant subject of body weight: 133 lbs, height: 63.3 inches and body mass index (BMI): 23.3, enrolled in a prospective observational safety study. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. The subject's past medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness, nexium and famotidine both for acid reflux. The subject's concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. The subject's obstetrical history included one previous pregnancy with one full term live birth. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal or paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 24-Jun-2020. The subject's estimated delivery date (EDD) was reported as 31-Mar-2021 and corrected estimated date of delivery (CEDD) was reported as 01-Apr-2021. The type of pregnancy was singleton. On 25-Aug-2020, the ultrasound revealed no MCM. On 02-Sep-2020, the counsyl chromosome 13, 18, 21 plus sex chromosome analysis and ultrasound revealed no MCM. On 12-Oct-2020, at approximately 15 weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100253284. On the same day, the maternal serum alpha fetoprotein screening (MSAFP/Serum marker) revealed borderline elevation for spina bifida and it was unknown if MCM was noted. On 20-Oct-2020, the MSAFP/Serum marker - repeat revealed no MCM. On 03-Nov-2020, the ultrasound revealed partial placenta praevia and fluid collection near left kidney related to baby. On 01-Dec-2020, the ultrasound revealed MCM: lymphangioma of foetus. The outcome of the event 'placenta praevia' was not reported. The reporter did not provide a causality assessment. The event of 'placenta praevia' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. This case is linked with case 202008416, due to the corresponding baby case. Additional information received from other health professional on 21-Dec-2020 with additional document received on 29-Dec-2020: Two additional lab tests added. Placenta praevia added as event and case was upgraded from non-serious to serious. Fluid collection near left kidney related to baby and lymphangioma noted as baby case opened. The narrative was amended accordingly. Company comment: A 28-year-old, female, pregnant subject experienced placenta praevia approximately 28 days after administration of Afluria QIV. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. Concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. Causality is assessed as not related due to chronological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: Company comment: A 28-year-old, female, pregnant subject experienced placenta praevia approximately 28 days after administration of Afluria QIV. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. Concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. Causality is assessed as not related due to chronological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.

Other Meds: DEXILANT; CIMETIDINE; CITALOPRAM; PHENERGAN [PROMETHAZINE]; ZOFRAN [ONDANSETRON]; SUCRALFATE

Current Illness: Acid reflux (oesophageal); Anxiety; Morning sickness

ID: 0918982
Sex: F
Age: 37
State: GA

Vax Date: 12/28/2020
Onset Date: 01/02/2021
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: sulfa

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

Symptoms: Left arm large golf ball size knot, tender, red, itchy, stiffness in arm

Other Meds: nuva ring

Current Illness: none

ID: 0918985
Sex: M
Age: 49
State: CA

Vax Date: 12/16/2020
Onset Date: 12/19/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.

Other Meds: Metformin, Valsartan, Adderall, Asprin, Testosterone Enanthate, Anastrozole.

Current Illness: Had skin infection and took antibiotics 2 weeks prior

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm