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

ID: 1039519
Sex: F
Age: 75
State: NE

Vax Date: 02/04/2021
Onset Date: 02/10/2021
Rec V Date: 02/18/2021
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: Benadryl -- horrific dreams, sleepy

Symptom List: Dysphagia, Epiglottitis

Symptoms: Redness and swelling, warmth in the area of injection site and stinging, itching, and burning pain (like an insect bite) 6 days following vaccination. Symptoms lasted about 4-5 days. Application of ice on the affected area, which helped the area feel better. Then on the evening of February 17, the signs and symptoms reappeared.

Other Meds: Aspirin 81 mg once a day Bydureon 1mg/0.65 mL once weekly Calcium 600 + D3 600mg Calcium - 200 unit capsule once daily CBD oil 1 drop under the tongue PRN Colesevelam 625 mg; 3 tablets BID Furosemide 40 mg; qAM PRN Lamictal 200 mg QPM Lexap

Current Illness: Sick for at least a week, fever for 3 days about 10 days before the vaccine.

ID: 1039520
Sex: F
Age: 34
State: VA

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
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: Clindamycin

Symptom List: Anxiety, Dyspnoea

Symptoms: Patient came back to pharmacy two days after she received the vaccine and admitted that immediately after receiving the vaccine, her heart was racing and she was having feelings of swollen throat and tongue. However, at the time, she did not say anything and went home after 30 minutes of observation. After the vaccine, her arm was first sore and a couple of days later, the soreness turned into an itching. The itch is local around injection site on left arm. Potential allergic reaction, lasting for days post injection.

Other Meds: none

Current Illness: n/a

ID: 1039521
Sex: M
Age: 73
State: CA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
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: Penicillin

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

Symptoms: Day after injection I woke up feeling achy all over muscle and joints, tired, slight fever

Other Meds: Multivitamins, potassium, Tamusin, metformin, atavastatin, buphrin

Current Illness: None

ID: 1039522
Sex: F
Age: 45
State: IL

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Hx of allergies to avalox, dog dander, latex, pollen, trees weeds and ragweed.

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Pt complained of general malaise, hives were noted on upper extremity after 20 min in observation. Pt also have consistent systolic elevated BP readings >200

Other Meds: Patient reports no medication or supplements

Current Illness: No reported illnesses one month prior to vaccine.

ID: 1039523
Sex: F
Age: 66
State: KS

Vax Date: 01/29/2021
Onset Date: 02/06/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Contrast dye in CT scan dye Fluoroquinolones Codeine in Tylenol 3

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

Symptoms: Day 8 post vaccination in upper right arm I awoke to a pink itchy blotch around the injection site - approximately 2 by 2 inches. Over the course of the day the blotch grew in size and in itch intensity and became sore, warm to the touch and somewhat hardened.. After reading about "Covid arm" in online sources, I treated with topical steroid cream. The blotch continued to increase in size on the following day but decreased somewhat in intensity. Final size approximately 5 inches long and 3 inches wide. Third day blotch was improved and continued to improve daily. Itching was much diminished. By Day 6 blotch could still be seen but was non-reactive. Today is Day 14 and I can still see a telltale sign of the original blotch but is totally non-reactive. I did contact my primary care MD and sent photos of issue. She suggested I report. Nurse followed up with phone call regarding recommendations for second dose.

Other Meds: Lisinopril, Hydrochlorothiazide, Progesterone, Cholestyramine Magnesium, Vitamin B Complex, Vitamin B12, Vitamin C, Vitamin D, Ubiquinol, Zinc Fish Oil, Curcumin, Rhodiola, NAC, Alpha Lipoid Acid, Digestive Enzymes, Probiotic, Astragalus, C

Current Illness: None

ID: 1039524
Sex: F
Age: 27
State: AK

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: At 8 pm the day I had the shot I started having a headache and muscle aches on both hips. The following day I was nauseous, light-headed, had a headache, muscle aches around my hips, pain at injection site, and was weak. I passed out for an unknown amount of time around 11 am that Sunday. I was unable to eat more than two pieces of pilot bread, but I kept drinking water and was hydrated. I kept rolling around trying to get comfortable, but the muscle pains in my hips would not let me until I used a heating pd. The following day I was weak, but no longer as nauseous or have as bad a headache. On Tuesday, I was able to get up, but both arms felt very weak and it was a strain to carry my bag and computer. Wednesday I was still very tired, but more like myself. No symptoms today February 18.

Other Meds: advil

Current Illness:

ID: 1039525
Sex: F
Age: 72
State: GA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Error: Wrong Dose of Vaccine - Too High

Other Meds:

Current Illness:

ID: 1039526
Sex: M
Age: 27
State: FL

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 02/18/2021
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: Approximately two hours after injection, slight discomfort and soreness about 2 inches in radius below the the injection site, but not at the point of contact. Movement of the upper arm produced some levels of pain, but nothing noteworthy. It was uncomfortable to sleep on, though, so that was avoided. Lower arm unaffected. The following morning, the pain was immediately noticeable and made using the arm a severely difficult task. It was painful to move the forearm above stomach level, and essentially impossible to do any sort of heavy lifting with it. Pain relieving medication such as aspirin and ibuprofen helped in a minimal capacity, and was ultimately irrelevant in the healing process. These symptoms lasted the entirety of the day after the injection and most of the following day as well, subsiding mostly in the evening. Today (Thursday, third full day after), all pain and soreness/dullness are entirely gone. The second full day was easily the most intense in terms of pain.

Other Meds:

Current Illness:

ID: 1039528
Sex: M
Age: 22
State: NY

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Gluten. Casein. Soy

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Developed fever at 4 am. Single dose of Tylenol worked to bring down fever. No further doses needed. Fever did not return. Next day after shot had slight runny/stuffy nose.

Other Meds: Risperidone. Prozac. Vitamin D

Current Illness: none

ID: 1039529
Sex: F
Age: 70
State: NY

Vax Date: 02/09/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
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: none

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Patient stated everything was ok until 2/17/2021 when the injection site became warm. swollen and painful. No other reactions were reported by patient

Other Meds: none

Current Illness: none

ID: 1039530
Sex: F
Age: 62
State: IN

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Penicillin Codeine Erythromycin Iodine Tetracycline Seafood/Shellfish

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

Symptoms: Swelling of tongue, medicinal taste, burning in nostrils following the vaccination. Next day headache, confusion in speech and thinking, constricted breathing in throat and chest, fatigue.

Other Meds: Levothyroxine Meloxicam Escitalopram Bupropion Diazepam Pravastatin Oxycodone-Acetaminophen Centrum Silver Vitamin D3 Ocuvite Lutein and Antioxidants

Current Illness: None

ID: 1039531
Sex: F
Age: 38
State: NE

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 02/18/2021
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: Nine

Symptom List: Rash, Urticaria

Symptoms: I woke with extreme chills. I had a low grade temp of 99.6, when I got up for work. I went to work. When I got there I started to sweat intensely. This cycle happened throughout the day. I went to bed at 8:30pm and woke up the next day at 9, feeling back to normal.

Other Meds: None

Current Illness: None

ID: 1039532
Sex: F
Age: 34
State: CA

Vax Date: 02/07/2021
Onset Date: 02/07/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: NKDA

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

Symptoms: Covid19 Moderna Vaccine: throat itching, facial flushing, "cotton ball" in throat, left chest tightness, diphenhydramine at 2:07pm, reclined, 30 mins observation. resolved

Other Meds:

Current Illness:

ID: 1039533
Sex: M
Age: 53
State: OH

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Error: Wrong Patient (documentation in EMR)

Other Meds:

Current Illness:

ID: 1039534
Sex: F
Age: 44
State:

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
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: Dizziness,spinning, P83, 97% O2. 122/82

Other Meds:

Current Illness:

ID: 1039536
Sex: F
Age: 70
State: NJ

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 02/18/2021
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: Any fruit with edible skin

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

Symptoms: Tingling and numbness in right hand

Other Meds: Mercaptopurine, mesalamine, vita d, b complex, Omega 3, Preservision vitamin for eyes

Current Illness: None

ID: 1039537
Sex: F
Age: 66
State: IN

Vax Date: 02/10/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
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: septra DS; Cefzil; Amoxil

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

Symptoms: No adverse effects on day of vaccine or days following. Today, 2/18/2021 feel swelling and warm to the touch at injection site

Other Meds: Prem-Pro .45-1.5 mg; D3 25 mcg; calcium 1200 mg; Centrum Silver multi vitamin

Current Illness: none

ID: 1039538
Sex: F
Age: 66
State: WA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: ciprofloxacin: planter fascitis, neuritis reaction, contrast m

Symptom List: Ear pain, Hypoaesthesia

Symptoms: per patient report: "103.5 fever with heart rate of 100-120s. Farmer's Lung activated with profound coughing. O2 sats went transiently low to 85 but mostly 91-92%. Became very unsteady on feet, requiring support of walls, furnishings and counters. Horrible chiari headache with bad nausea Neuropathy in BLE flared, legs were buzzing and I was getting intense spasms of bilateral feet and ankles that made it hard to use them. Visual decline Passed out twice cold in the bathroom [found myself in bathroom, when "I came to"] In bed for 3 days except to use the restroom and make tea. Could not attend to any other ADLs. Injection site red from shoulder to elbow, swollen and itchy with axillary lymph swelling". Symptoms

Other Meds: Vit D3, Mg, K2, CoQ10, B complex

Current Illness: no

ID: 1039539
Sex: F
Age: 69
State: CA

Vax Date: 02/09/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Septra.

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Site of Moderna vaccine started slightly itching, 2/16/21. 2/17/21, after 4 mile run, same site are severe itch. Felt seizable lump. When looked, area very swollen (size of half golf ball), very red and rashy.

Other Meds: Focus Factor (brain); Omega-3 Fish Oil; B12: Flaxseed Oil; Lutein & Zeaxanthin (vision); probiotic; Turmeric.

Current Illness:

ID: 1039540
Sex: F
Age: 66
State: FL

Vax Date: 02/11/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Bactrim

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

Symptoms: 6 days after the 2nd vaccine suddenly my upper arm is very sore and hurts to move it. No pain at all until 6 days after the 2ndshot.

Other Meds: Calcium, Multi-vitamins, Atenolol

Current Illness: none

ID: 1039542
Sex: F
Age: 21
State:

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 02/18/2021
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: Patient did not receive the vaccine at our hospital, but reporting since she presented to the ED. Patient presents to ER. Reports is a student teacher through school and received Moderna COVID19 vaccine yesterday. States that she started having high heart rate today, between 120-160. On presentation, patient's heart rate was elevated, measuring from 110-160 in the ER. Patient also had 103F oral temperature. Patient denies taking any other medication. Patient ultimately had to have labwork and imaging done. Will give tylenol for fever and NS bolus. Labs imaging to include CBC, CMP, Mg, lactic acid, TSH/Free T4, UA, urine preg, CXR, and EKG. EKG with sinus tachycardia and S1Q3T3 pattern. CXR without evidence of acute cardiopulmonary process. D dimer 640. Mg 1.6, Na 133, K 3.4. TSH/T4 unremarkable. UA with trace leukocyte esterase. Given EKG findings and elevated d-dimer, will obtain CT w contrast to rule out PE. CT does not show evidence of acute PE. Patient is afebrile and stable for discharge. Discussed with patient that symptoms are likely due to inflammatory reaction following the COVID vaccine. Recommend symptomatic treatment at home and activity as tolerated.

Other Meds: None

Current Illness:

ID: 1039543
Sex: M
Age: 82
State: MA

Vax Date: 02/05/2021
Onset Date: 02/10/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: sulfasalazine

Symptom List: Unevaluable event

Symptoms: rash appeared on torso day 5, diffuse blanching, slightly itchy, progressed, covering entire back by day 5 post vaccination.

Other Meds: none

Current Illness: none

ID: 1039544
Sex: F
Age: 73
State: NV

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/18/2021
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: penicillin, sulfa, ciprofloxacin, erythromycin

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

Symptoms: Rash started over chest, scalp, neck, and groin area

Other Meds: Famotidine, levothyroxine, atorvastatin, Vitamin D3, metoprolol tartrate, and irbesartan-hydrochlorathiazide

Current Illness: None

ID: 1039545
Sex: F
Age: 58
State: MO

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/18/2021
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: penicillin metformin

Symptom List: Injection site pain, Pain

Symptoms: The Department came to the work place to give COVID19 vaccines. Approximately 4 hours after receiving the 1st dose of the COVID vaccine, the patient/staff c/o feeling dizzy / double vision/ headache . her Blood pressure was high / blood sugar wnl she was becoming sluggish lungs were clear she was sent out to ED via EMS . She reported to this RN after the event that she was kept in the hospital until just before 2:00 am where they had her on IV fluids to bring her BP down.

Other Meds: Trulicity Lipitor 10 mg Terbinafine for toe amlodipine 20 mg albuterol PRN

Current Illness: none reported

ID: 1039546
Sex: F
Age: 40
State: VA

Vax Date: 02/10/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
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: Injection site pain, Menorrhagia

Symptoms: Swelling at the injection site Redness Itching Warm in that area

Other Meds: Blood pressure medicine Prozac

Current Illness: None

ID: 1039547
Sex: F
Age: 65
State: CA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
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: Patient feels heart rate increased or pacing, dizziness and tightness on throat a little bit then went away. Vital signs 110/78 mmHg, 78bpm, 98% O2 RA, 18 cpm #21. pt was sent home

Other Meds:

Current Illness:

ID: 1039548
Sex: M
Age: 60
State:

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
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: penicillins

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: 60 y/o male presents to UC and reports itching rash on scrotum and swelling of both hands after he had the COVID vaccine two days ago. Patient denies chest pain, SOB, fever, chills, difficulties swallowing, testicular pain or other complaints or issues at this time.

Other Meds: Amlodipine, fluoxetine, hydrochlorothiazide, mirtazapine, naproxen

Current Illness:

ID: 1039549
Sex: F
Age: 74
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: latex, methylisothiazolinone, synthetic fragances: skin

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: 4 hrs after vaccination, noticed a buzzing in my rt ear - tinnitus, constant since. It may be in both ears, but predominantly the rt ear

Other Meds: Nattokinase, Lutein, B-12, Omega-3, Melatonin,

Current Illness: very wet cough, especially upon waking

ID: 1039550
Sex: F
Age: 67
State: CA

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/18/2021
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: Developed rash on left arm and torso. Also developed headache, fatigue, and body aches on 2/10-2/12/21.

Other Meds:

Current Illness:

ID: 1039551
Sex: F
Age: 57
State: LA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Penicillin, ants, and latex

Symptom List: Nausea

Symptoms: Patient received COVID-19 Moderna 2 or 2 in series yesterday; then neck pain began next morning. Neck and back stiff and tender with doll ache severe at 10 out of 10 associated symptoms nausea headache fatigue and malaise chills. Treatment includes 1000 mg of Tylenol every six hours PRN, nonpharmacological methods including heating pad, rest in adequate fluid intake, instructed to return to clinic if symptoms worsen or become stagnant, if not resolved in one week, obtain x-ray and refer to oncology for history of pleomorphic adenoma tumor in neck

Other Meds: PANTOPRAZOLE 40 mg daily; ONDANSETRON 8 mg every 8 hours as needed; levothyroxine 112 mcg twice daily METFORMIN 500 mg twice daily. ESCITALOPRAM 20 mg daily. BUSPIRONE 7.5 mg three times daily. POTASSIUM CHLORIDE 20 mEq daily

Current Illness: None

ID: 1039552
Sex: M
Age: 72
State: MA

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Injection site pain

Symptoms: Body Rash

Other Meds: Amlodipine and Atorvastatin

Current Illness: None

ID: 1039553
Sex: F
Age: 61
State:

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies: Latex

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

Symptoms: Within 1 hour after 2nd dose of COVID vaccine had a strange sensation in R eye socket, but initially didn't think much of it. Then over next few hours, began having spreading Right sided face numbness, back of head, neck. Denies difficulty speaking or swallowing. Presented to ER. Resolved after a few hours. CT head unremarkable. Later that evening, severe chills, headache, arm soreness, fatigue. Fatigue persisting 6 days later.

Other Meds: Levothyroxine

Current Illness:

ID: 1039554
Sex: F
Age: 70
State: IL

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/18/2021
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: Kiwi, Codeine, environmental

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

Symptoms: Next day fever (102) chills headache. Gone by midday 2/13/21

Other Meds: Bedesinide, claritan, zertec, magnesium, vitamin D

Current Illness: None

ID: 1039555
Sex: F
Age: 31
State: KY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/18/2021
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: None

Symptom List: Tremor

Symptoms: 6 hours after receiving the vaccine l went to shower and noticed chicken pox like blister on my torso from my underwear line to my bra line. They were mostly located on my sides are were in a vertical pattern. I have initial pictures I can share if needed.

Other Meds: None

Current Illness: None

Date Died: 02/14/2021

ID: 1039597
Sex: M
Age: 63
State:

Vax Date: 01/30/2021
Onset Date: 02/14/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Death Narrative: Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: "due to sepsis (related to bed sores) and aspiration pneumonia"

Other Meds:

Current Illness:

ID: 1039871
Sex: U
Age:
State: MO

Vax Date: 09/07/2016
Onset Date:
Rec V Date: 02/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: zoster related pneumonia; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated Alternatively, on or about 07-SEP-2016, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the inoculation, the patient was treated for zoster related pneumonia and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of varicella zoster pneumonia and ill-defined disorder were not recovered. The reporter considered varicella zoster pneumonia and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, varicella zoster pneumonia was determined to be a medically significant event.

Other Meds:

Current Illness:

ID: 1039872
Sex: U
Age:
State: WV

Vax Date: 09/18/2017
Onset Date:
Rec V Date: 02/18/2021
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: stroke; severe urinary tract infection; cardiovascular issues; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 63-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) used: severe urinary tract infection, cardiovascular issues and stroke. The outcome of cerebrovascular accident, urinary tract infection and cardiovascular disorder were not reported. The reporter considered cerebrovascular accident, urinary tract infection and cardiovascular disorder to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, cerebrovascular accident was determined to be a medically significant event.

Other Meds:

Current Illness:

ID: 1039880
Sex: F
Age:
State:

Vax Date:
Onset Date: 12/01/2020
Rec V Date: 02/18/2021
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: immunodeficiency; Dry eyes aggravated; eye prosthesis insertion; eye pain; Plugs placed in eyes; mammogram abnormal; Head exploding; felt head exploding / headache was severe/ Headache aggravated; low grade fever; eye inflammation; Psoriasis flare-up/ hands Psoriasis / knee Psoriasis; stress; Psoriasis on nails; Butterfly rash; rosacea; This case was reported by a consumer via other manufacturer and described the occurrence of immunodeficiency in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis. Co-suspect products included adalimumab (Humira) solution for injection in pre-filled pen for psoriatic arthritis and levothyroxine sodium (Synthroid) tablet for thyroidectomy. The subject's past medical history included thyroid operation (had Thyroid surgery in 1986), eye dryness (had dry eyes), headache (had headache), heart rate increased (had Heart rate increased), hypertension (had hypertension), asthma (had asthma), knee replacement (had Knee replacement), fatty liver (had fatty liver diseases), c-section (had C section), liver enzyme abnormal (had unstable liver enzyme), pain in hip (had hip pain), pruritus, crawling sensation of skin (had ants crawling on skin due to codeine allergy), breathing difficult (had breathing issue due to sulpha allergy), rash (hexachlorophene allergy manifested by rash) and eye burns (inveltys allergy manifested by burned eyes). Previously administered products included codeine (had codeine), Loteprednol etabonate (received inveltys(Loteprednol etabonate)), HEXACHLOROPHENE (received hexachlorophene), BACTRIM (had bactrim), FLAGYL (received flagyl) and PLAQUENIL. Concurrent medical conditions included drug allergy (had allergy to codeine, hexachlorophine, Bactrim, Flagyl and inveltys.) and sulfonamide allergy (had sulpha allergy). Concomitant products included salbutamol sulphate (Albuterol), fluticasone propionate (Flovent), carvedilol, amlodipine besilate (Norvasc), amlodipine, montelukast sodium (Singulair), piroxicam, caffeine + ergotamine tartrate (Cafergot), cefixime (Flexeril (Cefixime)) and hydrocodone bitartrate + paracetamol (Norco). On an unknown date, the patient received Flu Seasonal QIV Dresden, Humira (subcutaneous) 40 mg at an unknown dose and frequency and Synthroid (oral) at an unknown dose and frequency. In December 2020, unknown after receiving Flu Seasonal QIV Dresden and an unknown time after starting Albuterol and Flovent, the patient experienced eye inflammation (serious criteria other: Other Medically Imp Condition), butterfly rash (serious criteria other: Other Medically Imp Condition), rosacea (serious criteria other: Other Medically Imp Condition), psoriasis flare-up (serious criteria other: Other Medically Imp Condition), stress (serious criteria other: Other Medically Imp Condition) and nail psoriasis (serious criteria other: Other Medically Imp Condition). On 28th December 2020, the patient experienced low grade fever (serious criteria other: Other Medically Imp Condition). On 31st December 2020, the patient experienced headache (serious criteria other: Other Medically Imp Condition) and exploding head syndrome. On an unknown date, the patient experienced immunodeficiency (serious criteria GSK medically significant and other: Other Medically Imp Condition), mammogram abnormal (serious criteria other: Other Medically Imp Condition), dry eyes aggravated (serious criteria other: Other Medically Imp Condition), eye prosthesis insertion (serious criteria other: Other Medically Imp Condition), eye pain and punctal plug insertion. The subject was treated with excedrin (nos) (Excedrin), ibuprofen (Advil), ibuprofen, paracetamol (Tylenol) and macrogol + propylene glycol (Systane). The action taken with Humira was unknown. The action taken with Synthroid was unknown. On an unknown date, the outcome of the eye inflammation, butterfly rash, rosacea, psoriasis flare-up, stress, nail psoriasis, low grade fever, headache, exploding head syndrome, immunodeficiency, mammogram abnormal, dry eyes aggravated and eye pain were recovered/resolved and the outcome of the eye prosthesis insertion and punctal plug insertion were unknown. It was unknown if the reporter considered the immunodeficiency, eye inflammation, headache, low grade fever, mammogram abnormal, butterfly rash, rosacea, dry eyes aggravated, psoriasis flare-up, stress, nail psoriasis, eye prosthesis insertion, eye pain, punctal plug insertion and exploding head syndrome to be related to Flu Seasonal QIV Dresden. Additional details were provided as follows: The patient had medical history of left quad rupture with repair, partial total knee repalcement and ACL repair. The age at vaccination was not reported. The patient performed mammogram in 2020 with breast tissue dense and something was found in the right breast around the nipple or areolar. on an unknown date, the patient experienced low immunity. in 2019, the patient experienced plugs palced in eyes and worsened dry eyes. in 2020, the patient experienced abnormal mammogram. in December 2020, the patient experienced eye inflammation, stress out, butterfly symptom or rosacea to face and psoriasis flare on right knee and both hands and nails. on 28th December 2020, the patient experienced low grade fever. on 31st December 2020,the patient experienced worsened headache/felt head explode. The reporter's causality for the event(s) of plugs palced in eyes was not provided. The reporter's causality for the event(s)of abnormal mammogram, eye inflammation, low immunity, stress out, butterfly symptom or rosacea to face onset in december 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache or felt head explode with humira 40mg/0.8ml(adalimumab) was no reasonable possibility. The reporter stated that there was no reasonable possibility that the events of plugs palced in eyes, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in december 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode are related to humira 40mg/0.8ml(adalimumab). The reporter stated that the events of abnormal mammogram and eye inflammation were not assessable. The reporter stated that there was a reasonable possibility that the event of low immunity is related to humira 40mg/0.8ml(adalimumab). The reporter's causality for the event(s) of plugs palced in eyes, abnormal mammogram, low immunity, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode was not provided. The reporter's causality for the event(s) of eye inflammation with synthroid(levothyroxine) was no reasonable possibility. The reporter stated that there was no reasonable possibility that the events of plugs palced in eyes, abnormal mammogram, eye inflammation, low immunity, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode were related to synthroid(levothyroxine).

Other Meds: Albuterol; Flovent; CARVEDILOL; NORVASC; AMLODIPINE; SINGULAIR; PIROXICAM; CAFERGOT; FLEXERIL (CEFIXIME); NORCO; HUMIRA; SYNTHROID

Current Illness: Drug allergy (had allergy to codeine, hexachlorophine, Bactrim, Flagyl and inveltys.)

ID: 1039881
Sex: F
Age: 71
State: FL

Vax Date: 01/13/2021
Onset Date: 01/19/2021
Rec V Date: 02/18/2021
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: Angioedema; A spontaneous report was received from a physician concerning a 71-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced angioedema of lip, mostly upper, part of lower, and into cheeks. The patient's medical history included angioedema. Concomitant product use was not provided by the reporter. On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient woke up with angioedema of the lip, mostly upper, part of lower, and it went into cheeks. Patient reported the same thing happened to her a fewyears ago with no known cause. Treatment for the event included a shot of prednisone and oral prednisone. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event angioedema of lip, mostly upper, part of lower and into cheeks was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient with a significant medical history of angioedema, who experienced a serious unexpected event of angioedema. The event occurred approximately 6 days after first dose of mRNA-1273, lot # 039K20A. Treatment for the event included a shot of prednisone and oral prednisone. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's prior medical history of angioedema may have been contributory.

Other Meds:

Current Illness:

ID: 1039882
Sex: F
Age: 34
State: WA

Vax Date: 01/14/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
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: Patient received the second dose 1 week before due date; A spontaneous report was received from a nurse concerning a 34 year old, female patient who received Moderna's COVID-19 vaccine and the patient received the second dose 1 week before due date (21 days after first dosage). The patient's medical history was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number: 031K20A) on 14-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second dose of mRNA-1273 (Batch number: 042L20A) on 04-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received the second dose 1 week before due date (21 days after first dosage). Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not unknown. The outcome for the event Patient received the second dose 1 week before due date was considered resolved on 04-Feb-2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 042L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1039883
Sex: F
Age:
State: NY

Vax Date: 01/06/2021
Onset Date: 02/03/2021
Rec V Date: 02/18/2021
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: Needle was loose; vaccine drip on arm; vaccine drip on arm; A spontaneous report was received from a health care provider concerning a 30 year old, female patient who received less than 2nd dose of Moderna Vaccine on (03Feb2021) because syringe leaked a few drops. This HCP did not administer the doses. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 06/Jan/2021. On 03Feb2021, approximately one month later, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. Nurse stated that needle was loose and full dose was not given because she noticed part of the vaccine that dripped out onto patients arm. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event, Needle was loose and vaccine drip on arm was considered resolved on an unreported date.; Reporter's Comments: This case concerns a 30 year old female patient who received second dose of the vaccine and experienced vaccine drip on arm due to needle being loose. There were no reported adverse events in this case of syringe issue and exposure via skin contact.

Other Meds:

Current Illness:

ID: 1039884
Sex: F
Age: 67
State: TX

Vax Date: 12/28/2020
Onset Date: 01/22/2021
Rec V Date: 02/18/2021
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: Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration, lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting. The patient's medical history was not provided. Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium. The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder. Treatment information for the events was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable. The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: ZEGERID [OMEPRAZOLE]; PROZAC; PROPRANOLOL; COLESTIPOL; BABY ASPIRIN; CALCIUM

Current Illness:

ID: 1039885
Sex: M
Age: 42
State: NY

Vax Date: 12/29/2020
Onset Date: 01/27/2021
Rec V Date: 02/18/2021
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: Face was paralyzed; A spontaneous report was received from a consumer concerning a 42-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis. The patient's medical history was not reported. Concomitant medication history was not provided. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient woke up to find that his face was paralyzed. The patient went to the urgent care center and they referred him to the emergency department at the hospital. After numerous tests they diagnosed him with Bell's Palsy. Treatment for this event included prednisone and doxycycline. Action taken with mRNA-1273 in response to this event was not reported. The outcome for the event, facial paralysis, was unknown.; Reporter's Comments: 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

Other Meds:

Current Illness:

ID: 1039886
Sex: F
Age: 66
State: NY

Vax Date: 01/06/2021
Onset Date: 02/02/2021
Rec V Date: 02/18/2021
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: Showing signs of hyperthyroidism; A spontaneous report was received from a consumer concerning a 68-year-old, female patient who received Moderna's COVID-19 vaccine and developed signs of hyperthyroidism. The patient's medical history was hypothyroidism. No relevant concomitant medications were reported. On 06 Jan 2021, patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) injection for the prophylaxis of COVID-19 infection. On 02 Feb 2021, within 28 days of receiving vaccine, patient had a six-month checkup that showed signs of hyperthyroidism when patient has history of hypothyroidism. The patient's healthcare professional consent was obtained. Treatment for the event was not provided. Action taken with the event was not reported. The outcome of the event, signs of hyperthyroidism, was considered ongoing.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. However, the patient's history of hypothyroidism may confound causality assessment. Further information has been requested.

Other Meds:

Current Illness:

ID: 1039887
Sex: F
Age:
State: MA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/18/2021
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: Anaphylactic reaction; Burning sensation in eyeballs; Wheezing; Rales; Airways were closing; Can't breathe; A spontaneous report was received from a consumer concerning a 22-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction, burning sensation in eyeballs/abnormal sensation in eye, wheezing, rales, airways were closing/obstructive airways disorder, and can't breathe/dyspnoea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Feb 2021, within 5 minutes prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, within 5 minutes after receiving her second dose of vaccine, the patient reported a burning sensation in her eyeballs, followed by wheezing and rales in her lungs. She was given epinephrine and taken to the emergency room via an ambulance. She was given a second dose of epinephrine. Her airways were closing and she could not breathe. She was given a steroid, diphenhydramine, H2 antagonist and albuterol. Consent given for follow up calls. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, anaphylactic reaction, burning sensation in eyeballs, wheezing, rales, airways were closing, and can't breathe, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1039888
Sex: U
Age:
State: FL

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
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: three 16 year old patients received their first dose of the Moderna vaccine; A spontaneous report was received from a pharmacist concerning three 16 year old patients who were administered a COVID vaccine at an inappropriate age. The patient's medical histories were not provided. Concomitant medication details were not provided On an unreported date, the patients received their first of two planned doses of mRNA-1273 (Batch numbers: 039K20A, 011L20A, 013L20A) some time between 11/Jan/2021 and 21/Jan/2021 intramuscularly for prophylaxis of COVID-19 infection. On an unreported date, three 16 year old patients were administered a COVID vaccine at an inappropriate age. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The event was considered resolved on an unreported date.; Reporter's Comments: This report refers to a case series of three (3) individual 16-year-old patients who each experienced the nonserious unexpected event of 'PT Product administered to patient of inappropriate age' for the first dose of mRNA-1273 (mRNA-1273 lots # 039K20A, 011L20A, 013L20A), with no associated adverse events in any patient. Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1039889
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/18/2021
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: arm pain; sleepless night; This is a spontaneous report from a non-contactable adult female consumer reported for herself that: A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced arm pain and sleepless night. The patient received no treatment. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1039890
Sex: M
Age:
State: HI

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
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: This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot: unknown, brand: Pfizer), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Pfizer product) at single dose for COVID-19 immunisation. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination or not. It was unknown whether the patient been tested for COVID-19 since the vaccination or not. It was reported that this was the second shot. The patient described muscle aches and a fever the night of the shot (on an unspecified date in Jan2021) and into the next day. It was unknown whether the patient received treatment for the adverse event or not. No seriousness criteria were reported for events. The outcome of the events was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1039891
Sex: F
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: UTI; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at an unspecified age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. In Jan2021, after the vaccination, the patient experienced a UTI (urinary tract infection). Treatment for the event UTI included sulfamethoxazole/trimethoprim (BACTRIM). The outcome of the event UTI was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1039892
Sex: M
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received on the left arm BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on the left arm on 01Feb2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL [IBUPROFEN]) and pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]). On 02Feb2021 02:00 AM, the night following the vaccination patient had headache and sore arm. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a workplace clinic. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the events was recovered on an unspecified date.

Other Meds: TYLENOL; ADVIL [IBUPROFEN]; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]

Current Illness:

Total 2021 VAERS Injuries: 0

Page last modified: 03 October 2021 5:28pm