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: 1413597
Sex: F
Age: 38
State: TX

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: Maybe Benadryl

Symptom List: Dysphagia, Epiglottitis

Symptoms: 1. Day 1 -- Immediately started feeling dizziness, weakness and sickness. I can not think clearly. My body was cold. Too weak and dizzy to walk. I stayed in a bed for about 40 minutes. Couldn't drive, At that night I had pains all over my body. 2. Day 2 -- Still felt dizzy and had mild allergic reaction: my eye areas were reded, swallowed a little and itchiness on my eyes and around them. See floats. Still couldn't drive cos of the dizziness. 3. Day 3 -- Still feeling dizzy and tired. Floats are almost gone.

Other Meds: No

Current Illness:

ID: 1413598
Sex: F
Age: 71
State: CA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 06/21/2021
Hospital: Y

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

Lab Data:

Allergies: Narcotics (N &V)

Symptom List: Anxiety, Dyspnoea

Symptoms: 20 min. after delivery of 1st Moderna vac. I experienced chest pressure and pain lasting 30-45 sec. For 5 days after that 1st event I experienced increased chest pain and pressure upon exersion. The pain/pressure eventually felt in throat, jaw and head area. After 5 days my Dr. sent me to ER where I had numerous tests. It was determined that I had a left artery that was 99% occluded. I had 2 stents placed. and was hospitalized for 4 days. Prior to the vac., I was symptom free.

Other Meds: Methotrexate, Folic Acid, Nabumetone, Amlodipine, Omeprazole DR, Goli Nutrition Apple Cider Vinegar Gummies

Current Illness: Rheumatoid Arthritis

ID: 1413599
Sex: M
Age: 34
State: OR

Vax Date: 06/15/2021
Onset Date: 06/18/2021
Rec V Date: 06/21/2021
Hospital: Y

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: None

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

Symptoms: He had fever and muscle aches 1-2 days post vaccine but on day 3 post vaccine he got chest pain and was found to have elevated troponin c/w myocarditis. cardiac MRI pending.

Other Meds: multivitamin and Claritin daily

Current Illness: None

ID: 1413600
Sex: F
Age: 54
State: CA

Vax Date: 04/06/2021
Onset Date: 05/13/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: N/A

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Vaccine dose 1 on 4/6/21, 2 on 4/27/21. 1-Symptoms of Graves disease possibly experienced around end of April/begin May 2021-Graves disease flare detected by elevated T3, T4 and suppressed TSH levels on 5/17/21, in treatment with methimazole. 2-Herpes simplex/cold sore on the lip, treated with valacyclovir, resolved. 3-Tinnitus experienced around 4/20/21, not resolved.

Other Meds: Vit D

Current Illness: N/A

ID: 1413601
Sex: F
Age: 28
State: GA

Vax Date: 04/19/2021
Onset Date: 05/17/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: Erythromycin

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

Symptoms: Joint pain and swelling - multiple trips to the ER - chest pain Prescribed peroxicam, prednisone

Other Meds: Lexapro Prednisone Ketorlac

Current Illness:

ID: 1413602
Sex: M
Age: 27
State: CA

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 06/21/2021
Hospital: Y

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: none

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

Symptoms: Patient reported having intermittent shortness of breath shorty after the second covid vaccine and it is progressing over 1 month without reducing. Patient got admitted to our hospital and found by cardiologist to have cardiomyopathy with ejection fraction 15-20%, dilated ventricles with unknown etiology beside recent covid vaccine.

Other Meds: none

Current Illness: obesity

ID: 1413603
Sex: F
Age: 20
State: FL

Vax Date: 04/12/2021
Onset Date: 04/26/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: After about a week or less following each shot of the COVID-19 vaccine, my menstrual cycle began to experience SEVERE irregularities. As someone who has been on the same birth control for many many years (brand/type is NORG-EE oral contraceptives), with no previous issues and an extremely regulated cycle, the effects I experienced were far from normal. My periods came a week early, and lasted for the entirety of the rest of the cycle (totaling 2 weeks of bleeding). The bleeding was extremely heavy containing intense and large clotting for the entirety of the period. Aside from losing a tremendous amount of blood, I have experienced heavy cramping in the lower abdomen and lower/mid back regions both during these periods and even sometimes when I am not bleeding at all. These side effects coupled have caused me to feel fatigued to the point of feeling like I needed to pass out, and due to this I adopted to taking iron supplements daily during the irregular bleeding (chelated iron, 18 mg capsules as recommended). As a result of this concerning symptom, I scheduled a visit to see my primary OBGYN, and was told that this is a common issue that they have been seeing following patient vaccinations. It is my hope that my periods will be regular this month, but for now I am unsure that this issue has resolved.

Other Meds: Birth Control- NORG-EE

Current Illness: No other illnesses aside from dermatological conditions (guttate psoriasis)

ID: 1413604
Sex: F
Age: 47
State: TX

Vax Date: 06/12/2021
Onset Date: 06/16/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Pharyngeal swelling

Symptoms: Rash, bumps on neck, arms, legs

Other Meds: Claritin, Flonase

Current Illness: None

ID: 1413605
Sex: F
Age: 42
State: PR

Vax Date: 06/18/2021
Onset Date: 06/19/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: NONE

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Thirst; Chills; Fever; Generalized muscle aches (with greater intensity in legs and back); tiredness; and pain, swelling, redness, and hardening in the arm (injection area).

Other Meds: NONE

Current Illness: No

ID: 1413606
Sex: M
Age: 23
State: UT

Vax Date: 06/17/2021
Onset Date: 06/19/2021
Rec V Date: 06/21/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Heart attack

Other Meds:

Current Illness:

ID: 1413607
Sex: M
Age: 41
State: CA

Vax Date: 02/03/2021
Onset Date: 06/14/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Shingles - herpes zoster, Day -1 itching. Day 1 rash in right lumbar region. Day 2 rash spread further, urgent care, start of treatment with acyclovir. Day 3 spread slowed down, blistering. Day 4 blisters start to dry off. Currently Day 7, further improvement, hypersensitive skin in the right lumbar region.

Other Meds: None

Current Illness: None

ID: 1413608
Sex: M
Age: 55
State: MT

Vax Date: 05/21/2021
Onset Date: 05/27/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: Sulfa Aspirin NSAIDs Topiramate SSRI?s

Symptom List: Rash, Urticaria

Symptoms: Rash at the injection site appeared approximately 1 week after the shot at an initial size of approximately 2? in diameter. Within a a it increased to a size of approximately 4? by 8?. Also pumps started appearing on left leg on the shin. After 3 weeks a rash has spread to both the left and right inner side of elbows and to the top of the right foot while the injection site has almost completely healed. Treatment has consisted of antihistamines and triamcinolone cream .5% on the rash.

Other Meds: Belbucca Propranolol Colestipal Cyclopinzaprine Relpax Prevacid

Current Illness:

ID: 1413609
Sex: F
Age: 36
State: CA

Vax Date: 02/04/2021
Onset Date: 02/17/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: My first dose of the vaccine was on Jan 15, 2021, my second dose on Feb. 4th, 2021. Two weeks after my second dose I broke out in a rash over my entire face, neck, and upper chest. My face became red, hot, swollen, I had a burning sensation, and severe itching. Since then I have had the same rash recur monthly in the same manner (total of 5x now). I don't have any food or drug allergies and have never had an allergic reaction to anything. I treat the rash with benadryl, which I have to take consistently over two days until the rash begins to disappear.

Other Meds: None

Current Illness: None

ID: 1413610
Sex: F
Age: 63
State: CT

Vax Date: 04/01/2021
Onset Date: 04/03/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Pulsatile Tinnitus, First developed 2 days after second vaccination. Went to see an ENT doctor, he gave me hearing test, mine came out to have normal hearing, he prescribed me to take steroids for 6 days, it did not improve the symptoms. Then he ordered the MRI, the MRI report showed no major concern. Then I went to see doctor for second opinion? he reviews the MRI images on the computer for us to see together, MRI was fine, he said there's nothing he could do, there's no cure for tinnitus. Then he mentioned he had other patients came to see him for tinnitus, those were all happened after the vaccination.

Other Meds: Alprazolam, Propranlol, Letroxole, duloxetine

Current Illness: None

ID: 1413611
Sex: M
Age: 17
State:

Vax Date: 06/20/2021
Onset Date: 06/20/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: Denied

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

Symptoms: patient is a 17yo male who experienced a syncopal event approximately 10 minutes after receiving his first dose of the Pfizer covid-19 vaccine. while sitting in the observation area with his mother, patient began to feel light headed and nauseous. patient was assisted to yoga mat on ground with lower extremities elevated. Per pt and mother, patient has a significant history of anxiety, and also becoming light headed and nauseated, in association with medical procedures, specifically when involving needles. patient's mother also reports patient has "passed out" previously when he experienced a hypoglycemic episode. Patient reports only having eaten a cookie and a slice of bread for the entire day. Upon initial assessment, no acute distress noted, AOx4, verbal, able to make needs know, and answers questions appropriately. Respiration even and unlabored, lung sound clear to auscultation. after approx <1 minute, noted progressive decreased level of consciousness, patient was minimally responsive for <15 seconds. Noted patient with significant diaphoresis, patient skin and lips were slightly pale & intact. Respiration remained even and unlabored, lung sound clear to auscultation. no sx/sx of allergic reaction. patient's mother Denied any significant past medical history, or allergies. Patient was assessed while laying on yoga mat on ground with bilateral lower extremities elevated, in observation area. Physical examination and past medical history obtained simultaneously. Initial vital signs @ 1845 95/32 hr 49 O2sat 99% rr17. Patient started to regain consciousness after <15 seconds, with progressive alertness. After approx 1 minute patient was AOx4, verbal and able to make needs known. Patient was provided with a gatorade drink, and encouraged to finish entire drink. Continued to observe patient for an additional 30 minutes. No acute distress noted throughout that time. Respiration remained even and unlabored, lung sound clear to auscultation. denies dizziness, light headedness or other symptoms. Skin warm, dry and color appropriate for ethnicity. V/S@ 1853 111/51 hr 90 O2sat 99% rr18 , AOx4, no acute distress noted. @ 1900 Patient reported ?feeling better?, denied lightheadedness or nausea. V/S @ 1900 128/66 hr 92 O2sat 99% rr 18. Instructed patient's mother not to leave patient unattended for remainder of day, and encouraged oral hydration. Instructed to call 911 if experiencing return of initial symptoms, difficulty breathing or loss of consciousness. Educated patient and his mother on sx/sx of allergic reactions, and anaphylaxis. Encouraged patient to follow up with his PCP. patient and his mother expressed understanding of all instructions and education. V/S @ 1930 135/72 hr 83 O2sat 98% rr18, no acute distress noted, patient denied any symptoms at that time. Patient left home with mother @ 1930.

Other Meds: Denied

Current Illness: Denied

ID: 1413612
Sex: M
Age: 49
State: IL

Vax Date: 05/20/2021
Onset Date: 06/12/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Lingering pain at site of injection in left arm. Following initial pain lasting 3-4 days the pain returned on 23rd day following shot. Continuous pain ranging from dull to sharp, treated at home with ibuprofen/acetaminophen, and heat wraps. Today is day 32 since the shot and the pain is still present

Other Meds: None

Current Illness: None

ID: 1413614
Sex: F
Age: 57
State: TX

Vax Date: 06/18/2021
Onset Date: 06/19/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: High fever 103 unrelieved by tylenol, explosive headache, piercing eye pain, blurry vision, double vision, heart pain, kidney pain, muscle and joint pain.

Other Meds:

Current Illness:

ID: 1413615
Sex: F
Age: 25
State: GA

Vax Date: 06/11/2021
Onset Date: 06/12/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Ear pain, Hypoaesthesia

Symptoms: 10 hours after the vaccine: fever, chills, body ache, diarrhea, abdominal cramps, light headedness. Treatment: electrolytes and paracetamol. Symptoms resolved after 24hours 9 days after the vaccination: headache, fatigue Treatment: ibuprofen 10days after vaccination: fever 100.8, chills, body ache, skin sensitivity, fatigue, & mild headache. Treatment: Paracetamol

Other Meds: None

Current Illness:

ID: 1413616
Sex: M
Age: 32
State: NV

Vax Date: 04/07/2021
Onset Date: 05/12/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: None.

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Immediately after a whole blood donation, as I was walking from the donation chair to the waiting area I felt nauseous and lightheaded. Upon sitting in the waiting area I put my head down on a table and my vision began going dark. I was able to make eye contact with a phlebotomist who asked if I was okay, to which I could only shake my head ?no?. They rushed to me with ice packs and moved me back to the donation chair so I could sit in a recliner position. As I started to feel less faint they gave me apple juice, Oreos, and gordettos. I felt better within 30 minutes. The phlebotomist thought the reaction may have been due to a poor meal beforehand, which consisted of two litelife veggie dogs on white buns with ketchup, veggie chips, and cookies.

Other Meds: Occasionally Ibuprofen and Acetaminophen, for one week before the adverse event was taking a daily multivitamin, Kirkland brand, to increase blood iron content to meet the requirement for donating blood.

Current Illness: None.

ID: 1413618
Sex: F
Age: 23
State: NY

Vax Date: 06/15/2021
Onset Date: 06/17/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cough Body aches Fatigue Laryngitis Trouble breathing

Other Meds:

Current Illness:

ID: 1413619
Sex: F
Age: 46
State: CA

Vax Date: 06/19/2021
Onset Date: 06/20/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: Sulfa

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

Symptoms: Fever Sweating Pain in muscles Pain in joints Skin feels hot and sensitive Dry mouth Headache Extreme Fatigue Tremors Inability to concentrate Shortness of breath Sore throat Impaired ability to work

Other Meds: Protonix Prozac

Current Illness: N/a

ID: 1413620
Sex: F
Age: 46
State: IL

Vax Date: 03/23/2021
Onset Date: 06/13/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies: Sulfa, strawberry, eggplant, kiwi

Symptom List: Unevaluable event

Symptoms: Dose 1:fatigue, arm stiffness Dose2: Major Fatigue, body ache, headache, Chills large swelling under right arm (lymph nodes) Breakthrough Covid infection (06/15/2021) after vaccine series

Other Meds: Amlodipine 5mg

Current Illness: -

ID: 1413632
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: PARTIAL DOSE OF VACCINE WAS ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose of vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose of vaccine was administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1413661
Sex: M
Age: 62
State: OH

Vax Date: 05/23/2021
Onset Date: 05/23/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: VARIVAX was administered intramuscularly instead of subcutaneously; VARIVAX was administered when Shingrix was the intended vaccine; This spontaneous report as received from a nurse practitioner referring to a 62 years old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported. On 23-MAY-2021, the patient was supposed to received his second dose of varicella zoster vaccine rge (cho)(SHINGRIX). However, on that day, he was given varicella virus vaccine live (oka/merck) (VARIVAX) instead (wrong product administered). In addition, the patient was given varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly instead of subcutaneously (incorrect route of product administration) (strength, dose and lot # not reported; expiration date reported as 23-JAN-2022; indication: prophylaxis). It was reported that the lot number and expiration date for the sterile diluent (manufacturer unknown) were T006519 and 31-OCT-2022 (strength and dose not reported; route: intramuscular) (incorrect route of product administration). No product quality compliance was reported.

Other Meds: STERILE DILUENT

Current Illness:

ID: 1413662
Sex: U
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: temperature excursion for PROQUAD and a dose was administered to a patient; no adverse event; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA))(PROQUAD) for prophylaxis (0.5 mL, lot # T018275 has been verified to be a valid number, expiration date was 23-NOV-2021; route of administration was not reported). The vaccine was exposed to a maximum temperature of 80 Fahrenheit for 23 hours totally, which was detected by data logger (product storage error). There was no previous temperature excursion. No other adverse events were reported.

Other Meds:

Current Illness:

ID: 1413663
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: my arm swelled and was red and I broke out in hives; my arm swelled and was red and I broke out in hives; my arm swelled and was red and I broke out in hives; This spontaneous report has been received from a female patient of unknown age via Pfizer. Pertinent medical history and concomitant medication were not reported. She was allergic to a lot of antibiotics. On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported). On an unknown date, the patient experienced a reaction to the varicella vaccine where her arm swelled and was red, she broke out in hives. She was not sure if the hives were all over the body or just the arm. The outcome of the events was not reported. The events were considered to be related to the vaccine by the reporter because she learned that there was neomycin in the varicella vaccine, and she was allergic to a lot of antibiotics.

Other Meds:

Current Illness: Allergic reaction to antibiotics

ID: 1413664
Sex: F
Age: 29
State: MO

Vax Date: 05/27/2021
Onset Date: 05/27/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: No other adverse event reported; a pregnant patient received GARDASIL 9; Information has been received from a registered nurse regarding a 29-year-old female pregnancy patient. The patient's drug reactions, allergies, and concomitant therapy were not provided. On 27-MAY-2021, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# T025367, expiration date 18-NOV-2022; strength, dose and route were not provided) for vaccine (vaccine exposure during pregnancy). The patient's gestion period was 28 weeks and 5 days. The last menstrual period was calculated as 07-NOV-2020 and estimated date of delivery was calculated as 14-AUG-2021. The pregnancy outcome was pending. The fetal outcome was unknown. No other adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025367; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1413665
Sex: M
Age:
State: GA

Vax Date:
Onset Date: 06/04/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: patient received 1 MMR vaccine as a child but did not receive second dose as recommended; Patient had no reported side effects; an expired dose of MMR-II was given; Information has been received from a medical assistant referring to a 46 years old male patient. Information about concurrent condition, concomitant medication and drug reactions/allergies was unknown by reporter. On an unknown date, when the patient was a child, he was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type unknown)(M-M-R II) (0.5 ml; strength, route, batch/lot number and expiration date were not provided) but did not receive second dose recommended (inappropriate schedule of vaccine administered). On 04-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (0.5 ml, second dose, intramuscular, lot # R030813, expiration date 24-OCT-2020) for immunity to measles, mumps and rubella for school (expired vaccine used). The vaccine administered had no previous temperature excursions. The patient had no reported side effects.

Other Meds:

Current Illness:

ID: 1413666
Sex: U
Age:
State: TX

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: no other AEs reported; concomitant administration of PROQUAD and VARlVAX; Information has been received from a nurse referring to a patient of unknown age or gender. Information about pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided. On 08-JUN-2021, the patient had concomitant administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 injection, lot #: T036735, expiration date: 28-APR-2022, therapy type: recombinant Human albumin (RHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (1 injection, lot #: S032357, expiration date: 14-OCT-2021) (both vaccines' strength and route were not reported) for prophylaxis (inappropriate schedule of product administration). The patient was not exhibiting any side effects. No other adverse events (AEs) reported.

Other Meds:

Current Illness:

ID: 1413667
Sex: M
Age: 64
State: WI

Vax Date: 10/06/2009
Onset Date: 12/15/2013
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Adverse Reaction or Side Effects Experienced: None; date of vaccination: 06-OCT-2009 and 15-DEC-2013; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2008USA002320), concerning to a 69-year-old male patient. On 06-OCT-2009 and 15-DEC-2013, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively (Inappropriate schedule of vaccine administered). No adverse reaction or side effects experienced.; Sender's Comments: US-009507513-2008USA002320:

Other Meds:

Current Illness:

ID: 1413668
Sex: U
Age:
State:

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: No additional AE reported; M-M-R II has been administered to a patient since the excursion occured; This spontaneous report was received from a nurse referring to a patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On 09-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of recombinant human albumin (rHA)) (M-M-R II) (strength, dose, route were unknown, lot # T007235, expiration date 27-FEB-2022) for prophylaxis since the excursion occurred. The temperature was 53 Fahrenheit degree for 1 hour and 15 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse event or product quality complaint was reported.

Other Meds:

Current Illness:

ID: 1413669
Sex: U
Age:
State: KY

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: no other AE; a dose of PROQUAD was administered after experiencing a temperature excursion.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On 06-APR-2021, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) (lot # t005404 was evaluated and changed to T005404 based interval rules, expiration date was reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021; strength and route were unknown) was administered for prophylaxis after experiencing a temperature excursion at 37.2 degrees Fahrenheit for 3 hours (product storage error). There was no previous temperature excursion. The call was due to digital data logger. No other AE occurred. No PQC.

Other Meds:

Current Illness:

ID: 1413670
Sex: F
Age: 66
State: IN

Vax Date: 10/01/2016
Onset Date: 10/01/2017
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via a Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2008USA003287), concerning to a 67-year-old female patient. In October 2016, October 2017, October 2018, October 2019, and October 2020, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively (Inappropriate schedule of vaccine administered).; Sender's Comments: US-009507513-2008USA003287:

Other Meds:

Current Illness:

ID: 1413671
Sex: U
Age:
State: KY

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Confirmed with customer that no other AE occurred; PROQUAD was administered after experiencing a temperature excursion; Information has been received from a nurse concerning a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 27-APR-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin (rHA)) (strength, route, lot# T005404 and expiration date expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021) for prophylaxis. This vaccine experienced a temperature excursion (incorrect product storage). The vaccine was stored in 37.2 Fahrenheit degrees (F) for 3 hours. There was no previous temperature excursion reported. Digital data logger was involved. The reporter confirmed no other adverse event (AE) occurred.

Other Meds:

Current Illness:

ID: 1413672
Sex: M
Age:
State: FL

Vax Date: 07/08/2020
Onset Date:
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: has not received their second dose in the series; This spontaneous report was received from a pharmacist and refers to a 41 years old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2020, the patient was the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. But the patient had not received the second dose in the series (inappropriate schedule of vaccine administered).

Other Meds:

Current Illness:

ID: 1413673
Sex: M
Age:
State: WA

Vax Date: 07/01/2020
Onset Date: 06/11/2021
Rec V Date: 06/21/2021
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: No additional adverse event or product quality concern; Patient received PROQUAD on 06/11/2021 and had received MMRII and VARIVAX in July of 2020; Information has been received from a nurse prescriber concerning a 5 years old male patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On ??-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot# and expiration date were unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route, lot# and expiration date were unknown) both for prophylaxis. On 11-JUN-2021, because the nurse prescriber was unaware of he had received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were unknown) 0.5 milliliter once for prophylaxis (wrong vaccine administered). No additional adverse event or product quality concern.

Other Meds:

Current Illness:

ID: 1413674
Sex: U
Age: 0
State: TX

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: no additional AE information reported; a temperature excursion on ROT ATEQ and product administered; This spontaneous report was received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 07-JUN-2021, the patient was vaccinated with singe dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported, lot # T033812, expiration date 29-DEC-2021) orally for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to a temperature of 47 Fahrenheit (F) for a time frame of 1 hour. No digital data logger was reported. There were no previous temperature excursions. No additional adverse event (AE) information was provided. This is one of the several reports reported by the same reporter.; Sender's Comments: US-009507513-2106USA003944: US-009507513-2106USA004087: US-009507513-2106USA004106: US-009507513-2106USA003971:

Other Meds:

Current Illness:

ID: 1413675
Sex: U
Age:
State: UT

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Caller notes no symptoms were reported. No additional AE's/PQC's reported; a temperature excursion that occurred on 5/27/2021 and notes (1) patient was given VARlAX on 6/10/2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 10-JUN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported, 1 dose, lot # T027299, expiration date was 12-AUG-2022) for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to a temperature of minus 11.8 degree Celsius for a time frame of 30 minutes, as recorded by the digital data logger (on 27-MAY-2021). There were no previous temperature excursions. No additional adverse event reported.

Other Meds:

Current Illness:

ID: 1413676
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: The PAP test came back positive for HPV Type 16; she was not sure if the vaccine involved was GARD ASIL or GARD ASIL 9; This spontaneous report was received from a nurse via a vaccine representative referring to a female patient of unknown age. The patient was not pregnant. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter. On unknown dates (reported as in patient's late 20s to early 30s), the patient received the 3 dose series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date, anatomical location and route of administration were unknown) for prophylaxis (reported as HPV prevention). It was reported that the patient was not sure if the vaccine involved was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product name confusion). On an unknown date (reported as recently), the patient had a papanicolaou (PAP) smear test performed. The PAP test came back positive for HPV Type 16. A colposcopy was performed on patient, which came back negative for HPV Type 16. The reporter was not aware of any error at the lab but was going to further investigate the discrepancy of results. It was reported that the patient had never been sexually active. No treatment was given for the event. The outcome of HPV test positive was unknown. The causality assessment between the event and suspect vaccine was not reported.

Other Meds:

Current Illness:

ID: 1413677
Sex: U
Age:
State: NM

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 06/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: No additional AEs; improperly stored administered GARDASIL 9; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 29-APR-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1691180, expiration date 15-NOV-2022, 0.5 milliliter) for prophylaxis (product storage error). Temperature excursion was 28.8 Fahrenheit degree for 2 hours and 35 minutes and 31.4 Fahrenheit degree for 0 hours and 15 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse event was reported. This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2106USA004138: US-009507513-2106USA003990 :

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1413678
Sex: U
Age: 0
State: TX

Vax Date: 06/05/2021
Onset Date: 06/05/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: No additional AE information reported.; temperature excursion; This spontaneous report was received from a medical assistant, referring to a 6-month-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported. On 05-JUN-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (single dose unspecified, lot # T033812, expiration date: 29-DEC-2021) orally for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour (product storage error). No previous temperature excursion was reported. No additional adverse event information reported.

Other Meds:

Current Illness:

ID: 1413679
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/21/2021
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: some neurological issues; This spontaneous report was received from a nurse practitioner concerning a female patient, who was her daughter's friend. No concurrent condition, medical history or concomitant therapy was reported. On an unknown date (reported as when the patient was younger), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and lot# were not reported) as prophylaxis. On an unknown date, the patient had some neurological issues (preferred term: nervous system disorder). The reporter believed the patient had fully recovered. However, the patient had to have one on one care. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable. The causality between the event of some neurological issues and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.

Other Meds:

Current Illness:

ID: 1413680
Sex: U
Age:
State: MI

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided. On 11-JUN-2021, the patient was vaccinated with incorrectly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (lot# was 1707457 or 1707460: lot# 1707457 has been verified to be a valid lot number, expiration date reported as 22-FEB-2022, but upon internal validation established as 23-FEB-2022; lot# 1707460 has been verified to be a valid lot number, expiration date reported as 13-MAR-2022, but upon internal validation established as 14-MAR-2022) (strength and dose were not reported) (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.

Other Meds:

Current Illness:

ID: 1413681
Sex: U
Age:
State: MI

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion. On 11-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA004356:

Other Meds:

Current Illness:

ID: 1413682
Sex: U
Age:
State: MI

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion. On 10-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA004356:

Other Meds:

Current Illness:

ID: 1413683
Sex: U
Age:
State: MI

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion. On 09-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA004356:

Other Meds:

Current Illness:

ID: 1413684
Sex: U
Age:
State: MI

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion. On 08-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA004356:

Other Meds:

Current Illness:

ID: 1413685
Sex: U
Age:
State: MI

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T005400, expiration date was reported as 11-AUG-2021 but upon internal validation established as 12-AUG-2021; lot # T028138, expiration date was reported as 14-FEB-2022 but upon internal validation established as 15-FEB-2022; lot # T025509, expiration date was reported as 22-JAN-2022 but upon internal validation established as 23-JAN-2022; lot # T025510, expiration date was reported as 22-JAN-2022 but upon internal validation established as 23-JAN-2022) underwent a temperature excursion. 11-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 7.3 Fahrenheit degrees (F) (6 F to 14 F) for 10 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA004356:

Other Meds:

Current Illness:

ID: 1413686
Sex: U
Age:
State: MI

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T003384, expiration date was reported as 27-JAN-2022 but upon internal validation established as 28-JAN-2022; lot # T007231, expiration date was reported as 26-FEB-2022 but upon internal validation established as 27-FEB-2022; lot # S023656, expiration date was reported as 29-JUL-2021 but upon internal validation established as 30-JUL-2021; lot # S039313, expiration date was reported as 03-DEC-2021 but upon internal validation established as 04-DEC-2021) underwent a temperature excursion. 09-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA004356:

Other Meds:

Current Illness:

ID: 1413687
Sex: U
Age:
State: MI

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies. It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 11-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2106USA004356:

Other Meds: VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm