VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1336155
Sex: M
Age: 14
State:

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

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

Lab Data:

Allergies: None

Symptom List:

Symptoms: Fatigue started 3 hours after shot. Woke up with bad fatigue the next morning, muscle aches, and headache. Headache has persisted. Treating with Ibuprofen

Other Meds: None

Current Illness: None

ID: 1336156
Sex: M
Age: 31
State: CO

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

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

Lab Data:

Allergies: None

Symptom List:

Symptoms: Insomnia

Other Meds: None

Current Illness: None

ID: 1336157
Sex: M
Age: 36
State:

Vax Date: 05/07/2021
Onset Date: 05/18/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Full body urticaria beginning on stomach and rapidly progressing to large area across stomach and back. Hives subsided and have resurfaced for several days across arms legs face torso . Over the counter antihistamine Allegra in combination with Benadryl at night and steroid pack initiated.

Other Meds:

Current Illness:

ID: 1336158
Sex: F
Age: 58
State: PA

Vax Date: 04/01/2021
Onset Date: 05/01/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List:

Symptoms: Swollen lymph node right clavicle

Other Meds: None

Current Illness: None

ID: 1336248
Sex: F
Age: 55
State: NE

Vax Date: 05/13/2021
Onset Date: 05/16/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Flu like symptoms, all over body aches, fever of up to 103.2 which has been ongoing for about 5 days now, loss of appetite, symptoms are finally subsiding.

Other Meds: Vit D 5000 iu, Vitamin B complex with 200 mg C

Current Illness:

ID: 1336249
Sex: F
Age: 42
State: MI

Vax Date: 05/01/2021
Onset Date: 05/21/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: Penicillin she'll fish and bactrim

Symptom List:

Symptoms: First shot gave me a tight chest and swollen throat right away day one about 40 minutes after receiving shot. That night I was woken up with burning ligament and tendon pain in my legs. This subsided after two days. Pain in all joints of foot, ankle, knees and elbows have been ongoing but not constant. The day after second shot tendons in thumbs on both hands became painful and popping. This hasn't went away and is constantly painful.

Other Meds: Tramadol

Current Illness: None

ID: 1336250
Sex: F
Age: 87
State: NY

Vax Date: 03/24/2021
Onset Date: 04/01/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: unknown

Symptom List:

Symptoms: severe joint pain, head aches, sweats

Other Meds: hydrocortisone, losartan, np thyroid

Current Illness: no

ID: 1336251
Sex: M
Age: 63
State: TX

Vax Date: 03/01/2021
Onset Date: 03/10/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: Lisiniprol, bees.

Symptom List:

Symptoms: Severe systemic arthritic reaction to all joints. Severity lasted 8 weeks, and although lessened, is still strong. Most effects in both shoulders, left elbow, left hand, both hips, both knees.

Other Meds: Bystolic 5mg, Atorvastatin 10 mg.Loratidine 10mg. Tylenol. Farxiga 5mg. Celebrex 200mg. Metformin ER 500mg 2x.

Current Illness:

ID: 1336252
Sex: F
Age: 49
State:

Vax Date: 05/19/2021
Onset Date: 05/20/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: chills and fever, migraine, nausea, fatigue

Other Meds:

Current Illness:

ID: 1336253
Sex: F
Age: 33
State:

Vax Date: 04/23/2021
Onset Date: 04/28/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Severe painful and heavy period, above and beyond what has been usual

Other Meds:

Current Illness:

ID: 1336254
Sex: F
Age: 40
State: NY

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

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

Lab Data:

Allergies: None

Symptom List:

Symptoms: Red Rash all over chest and neck

Other Meds: Lo Loestrin - birth control Spironolactone

Current Illness: None

ID: 1336255
Sex: F
Age: 22
State: GA

Vax Date: 05/17/2021
Onset Date: 05/18/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: N/A

Symptom List:

Symptoms: Woke up the morning after receiving the shot & felt fine, so I went to work. As the day went on, I got muscle aches and pains all through my body (especially in my left arm - the injection site - of course) and fatigue. It continually worsened throughout the afternoon and evening, despite bedrest and proper hydration, and I could barely sleep. However, the next morning I woke up just as I did the day before - no problems, feeling fine.

Other Meds: N/A

Current Illness: N/A

ID: 1336256
Sex: M
Age: 42
State: WI

Vax Date: 05/17/2021
Onset Date: 05/18/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List:

Symptoms: Swollen upper arm (below injection site) developed around 9 pm, Tuesday, May 18, 2021 and has not resolved. Large, pinkish, red patch developed around 5 am on Thursday, May 20, 2021 and has not resolved. I rested and took ibuprofen, with no results. Vaccine administrator stuck the needle at an angle, which likely caused much of the prolonged swelling.

Other Meds: None

Current Illness: None

ID: 1336257
Sex: F
Age: 47
State:

Vax Date: 03/14/2021
Onset Date: 03/20/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List:

Symptoms: Menstrual cycle changed: I got my period ahead of time, with very heavy bleeding. My period was always normal, in terms of amount, time, etc. At first, I didn't think of it was related to vaccine. However, after the second dose (on 4/11/2021) , same thing happened again: I got my period in shorter cycle, and the bleed was very heavy, running pure blood (didn't see tissue in) and drag for ~10 days, I basically had to bed rest to let it stop.

Other Meds: None

Current Illness: None

ID: 1336258
Sex: M
Age: 38
State: KY

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

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

Lab Data:

Allergies: Unknown

Symptom List:

Symptoms: pt received second dose of pfizer vaccine and within ten minutes started feeling dizzy and nauseated, sweating and feeling as though having a panic attack. Pt had syncope episode and ammonia inhalant used and pt non responsive. 911 called and pt monitored. Once pt placed on stretcher pt became more responsive and was able to state name and todays date, bp 109/62 p73 @ 15:48 / bp 109/74 p 88 @ 15:52. Pt verbal and states he is feeling better, states he has not had much to drink today and has been mowing today. EMS on scene and pt leaves clinic with EMS.

Other Meds: Unknown

Current Illness: Unknown

ID: 1336259
Sex: F
Age: 92
State: OR

Vax Date: 02/02/2021
Onset Date: 05/20/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies: Sulfa drugs

Symptom List:

Symptoms: Anaphylaxis

Other Meds: Sertraline (100mg @ 1/day), albuterol sulfate, NyQuil sleepeeze (1 dose at bedtime), NyQuil cold & flue (daytime, max. 1 dose per 6 hrs as directed during the day), fexofenadine HCI 180 mg (1/day, 7 doses in last 10 days).

Current Illness: Bronchitis/rhinitis,

ID: 1336260
Sex: F
Age: 36
State: OH

Vax Date: 05/01/2021
Onset Date: 05/18/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium

Other Meds:

Current Illness:

ID: 1336262
Sex: F
Age: 23
State: VA

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1336264
Sex: M
Age: 39
State: MD

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)

Other Meds:

Current Illness:

ID: 1336265
Sex: F
Age: 63
State: AZ

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Urinated on herself-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Immediately after vaccination she started to feel "awful" and unable to describe exactly what was wrong. She was lightheaded, shaky and dizzy. She lost consciousness for about 1-2 minutes and paramedics were called. Once consciousness was regained, she lied down and started to feel better. She continued to lie down until paramedics showed up and assessed her. She was feeling better and was not taken to the hospital.

Other Meds:

Current Illness:

ID: 1336266
Sex: F
Age: 59
State: CA

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Site: Pain at Injection Site-Severe, Systemic: limited shoulder range of motion-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

Other Meds:

Current Illness:

ID: 1336274
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: I got my shots and my arm hurt so much; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient 1st dose of Shingles vaccine and his/her arm hurt so much for days. For tolerance of 2nd dose refer case US2021AMR106809, reported with same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR106809:same reporter

Other Meds:

Current Illness:

ID: 1336279
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SUSPICION OF FLUID LEAK INTO EARS; DECREASED LUNG FUNCTION; LOSS OF PERIPHERAL VISION; NUMB LEGS; DIFFICULTY WALKING ACROSS THE ROOM/UNSTEADY GAIT; DIARRHEA; SHORTNESS OF BREATH; EXTREME VERTIGO; WEAK LEGS; HEADACHE/OCCIPITAL HEADACHE; ARTHRALGIA; SORE ARMS; MYALGIA; FATIGUE; FOGGY HEADED; ANAPHYLAXIS; FEVER; This spontaneous report received from a physician concerned a 30-year-old patient The patient's height, and weight were not reported. The patient's concurrent conditions included attention deficit hyperactivity disorder (ADHD), asthma, and milk allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry date were unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. The batch number was not reported has been requested. No concomitant medications were reported. On 10-APR-2021, within 30 minutes of vaccination, the patient developed anaphylaxis with no airway compromise, hives, swelling of limbs, face and administration site. The patient could not get immediate treatment for about an hour and then received Benadryl (diphenhydramine hydrochloride). On an unspecified date, in APR-2021, the patient experienced fever with a temperature of 100s (unit not provided). On 11-APR-2021, the hives started to go down with Benadryl treatment but it was not completely gone. On the same day, the patient experienced headache/occipital headache, arthralgia, sore arms, myalgia, fatigue and was foggy headed. On 12-APR-2021, the patient experienced shortness of breath, difficulty walking across the room (unsteady gait), extreme vertigo, diarrhea, numbness of legs and weakness of legs. It seemed like the patient was exhibiting symptoms of coronavirus disease (COVID-19). On 14-APR-2021, she eventually went to the emergency room (ER). The patient was tested for COVID-19 (swab test) and titres but both were negative. On an unspecified date, in APR-2021 (within 5 days of start of symptoms), a magnetic resonance imaging (MRI) without contrast was done and it did not show any blood clot, and D-dimer test was negative. The physician suspected a fluid leakage into the patient's ear and wanted to know if adenovirus from vaccine could be implicated. The patient was prescribed meclizine, but it did not help. On an unspecified date, a pulmonary function test (PFT) was done which showed decreased lung function. The patient also had steroid (unspecified) for 4 days. On an unspecified date, in MAY-2021 (about 8 days before report), the patient started to lose peripheral vision and her vertigo escalated. It was reported that the patient was due for an MRI on 12-MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arms, fatigue, foggy headed, myalgia, arthralgia, shortness of breath, difficulty walking across the room/unsteady gait, extreme vertigo, diarrhea, weak legs, fever, headache/occipital headache, loss of peripheral vision, anaphylaxis, numb legs, suspicion of fluid leak into ears and decreased lung function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520835-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness: ADHD; Asthma; Milk allergy

ID: 1336280
Sex: M
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: ACCIDENTALLY ADMINISTERED TWO DIFFERENT COVID 19 VACCINES; This spontaneous report received from a health care professional concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1816027, and expiry: UNKNOWN) .5 ml, administered on 07-MAY-2021 10:00 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 07-MAY-2021 10:00, the subject experienced accidentally administered two different covid 19 vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidentally administered two different covid 19 vaccines was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.

Other Meds: MODERNA COVID-19 VACCINE

Current Illness: Abstains from alcohol

ID: 1336281
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SORE THROAT; SHORTNESS OF BREATH; MYALGIA; FATIGUE; HORRIFIC HEADACHE; HORRIBLE PAIN IN CHEST LIKE HEART ATTACK; BONE WRACKING DRY COUGH; METALLIC TASTE IN MOUTH; FELT DIZZY; FELT LIKE HIT BY DUMP TRUCK; BODYACHE; NOT FEELING WELL; AGITATED; URINATING A LOT; BILATERAL EARACHE; WAS TOO SICK; HEART RATE WENT UP TO MORE THAN 80 BPM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 66.7 kilograms, and height was not reported. The patient's past medical history included tachycardia, atrial fibrillation, left periorbital ecchymosis, dry eyes, trouble focusing, headache, nausea on right side of chest, felt like gas bubble and emesis, possible post concussion symptoms, voice hoarse/raspy voice, chronic laryngitis, flare up of hemorrhoid, constipated over a weekend, increased heart rate, nontoxic uninodular thyroid goiter, atherosclerosis of aorta, fatigue, papillary thyroid cancer, right thyroid lobectomy, deep vein thrombosis, gerd, melanoma of skin, dyspnea, deep vein thrombosis, sinus pain, tooth pain, treatment non compliance, pharyngitis, stroke, vertigo, and influenza like illness, and concurrent conditions included non-smoker, no alcohol use, asthma, cerebral palsy, qt prolonged, chest pain when tired, diabetes mellitus, chronic kidney disease stage 3, hypertension, congenital nystagmus, hearing loss, hypothyroidism, and diabetes, and other pre-existing medical conditions included the patient had no history of abuse or illicit drug usage. The patient was previously treated with phenoxymethylpenicillin, guaifenesin for sore throat, calcium carbonate, famotidine, simeticone, promethazine, cefalexin, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination, salbutamol, ciclesonide, and polymyxin for red eyes; and experienced drug allergy when treated with atenolol, ciprofloxacin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 04-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included disopyramide phosphate. On 10-MAR-2014, Laboratory data included: Factor V Leiden mutation (NR: not provided) negative, and Prothrombin mutation G20210A (NR: not provided) HET Abnormal, coagulation. On APR-2021, the subject experienced heart rate went up to more than 80 bpm. On APR-2021, the subject experienced agitated. On APR-2021, the subject experienced urinating a lot. On APR-2021, the subject experienced bilateral earache. On APR-2021, the subject experienced was too sick. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced not feeling well. On 04-APR-2021, the subject experienced metallic taste in mouth. On 04-APR-2021, the subject experienced felt dizzy. On 04-APR-2021, the subject experienced felt like hit by dump truck. On 05-APR-2021, the subject experienced horrible pain in chest like heart attack. On 05-APR-2021, the subject experienced bone wracking dry cough. On 05-APR-2021, the subject experienced horrific headache. On 09-APR-2021, the subject experienced fatigue. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced sore throat. On 20-APR-2021, the subject experienced shortness of breath. On 20-APR-2021, the subject experienced myalgia. Laboratory data included: Anion gap (NR: not provided) 10 mEq/L, B-type natriuretic peptide (NR: not provided) 64 pg/dL, BUN (NR: not provided) 26 mg/dL, Blood pressure (NR: not provided) 214/91 mm Hg, Body temperature (NR: not provided) 97.8 F, CO2 (NR: not provided) 26 mEq/L, Chloride (NR: not provided) 102 mEq/L, Creatinine (NR: not provided) 0.92 mg/dL, Differential white blood cell count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) more than 60 mL/min, Glucose (NR: not provided) 328 mg/dL, Hematocrit (NR: not provided) 42.9 %, Hemoglobin (NR: not provided) 14.9 g/dL, Lab test (NR: not provided) Normal (no blood clots/thrombocytopenia), MCV (NR: not provided) 91 fL, Nucleated red cells (NR: not provided) 0 kilo per microliter, Oxygen saturation (NR: not provided) 98 %, Pain scale (NR: not provided) 1 (units unspecified), Platelet count (NR: not provided) 190 kilo per microliter, Potassium (NR: not provided) 4 mEq/L, Pulse rate (NR: not provided) 81 beats per minute, RBC count (NR: not provided) 4.73 million per microliter, Respiratory rate (NR: not provided) 18 (units unspecified), Sodium (NR: not provided) 138 mEq/L, Troponin I (NR: not provided) more than 0.02 ng/dL, WBC count (NR: not provided) 7.3 kilo per microliter, and X-ray (NR: not provided) Aortic atherosclerosis. Treatment medications included: hydralazine. On 20-APR-2021 17:34, Laboratory data included: Blood pressure (NR: not provided) 190/100 mm Hg, Body temperature (NR: not provided) 36.6 degree celsius, Glasgow coma scale (NR: not provided) Eye opening:4, Verbal response:5, Motor Response: 6, Total Coma Score:15, Oxygen saturation (NR: not provided) 97 %, Pulse rate (NR: not provided) 74 bpm, and Respiratory rate (NR: not provided) 16 (units unspecified). On 28-APR-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: estradiol, levothyroxine, paracetamol, verapamil hydrochloride, salbutamol, diphenhydramine hydrochloride/lidocaine/nystatin, budesonide/formoterol, guaifenesin, benzonatate, chlorhexidine gluconate, ipratropium, aciclovir, fluticasone, montelukast, hydralazine hydrochloride, fluticasone propionate/salmeterol xinafoate, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth on 05-APR-2021, felt dizzy on 20-APR-2021, felt like hit by dump truck on 16-APR-2021, was too sick, and shortness of breath, and horrific headache on 19-APR-2021, had not recovered from bone wracking dry cough, horrible pain in chest like heart attack, sore throat, and bilateral earache, and the outcome of heart rate went up to more than 80 bpm, myalgia, not feeling well, fatigue, urinating a lot, agitated and bodyache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious

Other Meds: NORPACE

Current Illness: Abstains from alcohol; Asthma; Cerebral palsy; Chest pain (for 30 years); Chronic kidney disease stage 3; Congenital nystagmus; Diabetes; Diabetes mellitus; Hearing loss; Hypertension; Hypothyroidism; Non-smoker; QT prolonged

ID: 1336282
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/21/2021
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Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via social media (press) via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, Expiry: Unknown) dose was not reported, 1 in total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was tested positive for covid after vaccination (confirmed covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000179465. The suspected product quality complaint has been confirmed to be voided: this is a duplicate record of 90000179465 forwarded this case to PQV management review to void. PQV management approval - confirmed no PQC was identified within the reported complaint reported. complaint is approved for void based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210526804-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

ID: 1336283
Sex: F
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 05/21/2021
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Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had tested negative for multiple antibody tests (confirmed immunological vaccine failure). According to reporter, the patient received vaccination 10 weeks ago. The reporter believed that the patient did antigen test for immunoglobulin G (IgG) and immunoglobulin M (IgM) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179671. The suspected product quality complaint has been confirmed to be not voided, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210529730-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1336284
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/21/2021
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Symptoms: RARE BLOOD CLOTTING DISORDER; This spontaneous report was received concerning 4 adult female(18-48 years) patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown exp: unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date within one to three weeks of vaccination, the patient experienced rare blood clotting disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare blood clotting disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210530468;-covid-19 vaccine ad26.cov2.s- Rare blood clots. This event is considered Un assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1336285
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/21/2021
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Symptoms: ASYMPTOMATIC COVID-19; This spontaneous report received via a company representative from online news articles, concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose and anatomical vaccination site were not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request the batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced asymptomatic covid-19. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210530878, 20210533998, 20210534001, 20210533999.

Other Meds:

Current Illness:

ID: 1336286
Sex: M
Age:
State: CT

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/21/2021
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Symptoms: ITCHING ON ARM; SOME REACTION; RASH ON ARM; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 14-MAY-2021 was received on 14-MAY-2021 and concerned a 69 year old male. The patient's weight was 106.59 kilograms, and height was 185 centimeters. The patient's pre-existing medical conditions included the patient did not had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced itching on arm. On MAY-2021, the subject experienced some reaction. On MAY-2021, the subject experienced rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on arm, rash on arm, and some reaction. This report was non-serious.

Other Meds:

Current Illness:

ID: 1336287
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/21/2021
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Symptoms: FAINTED; This spontaneous report received from a patient via a company representative concerned a 19 year old male of an unknown ethnicity and race. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: Unknown) dose was not reported, 1 total administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On the same day, the patient fainted (syncope) after vaccination. The patient woke up later and did not had to go to the hospital, however someone had to drive patient home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 06-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210535593-COVID-19 VACCINE AD26.COV2.S-fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1336288
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/17/2021
Rec V Date: 05/21/2021
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Symptoms: TIREDNESS; TINGLING FACE FOR 5 MINUTES; CLOSING OF THROAT ABOUT 5 MINS BUT AIRWAY CLEAR; TONGUE SWELLING FEW MINUTES; HOT FACE; HIGH BLOOD PRESSURE; HIGH HEART RATE; FEVER; This spontaneous report received from a pharmacist concerned a 56-year-old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis reaction to flu shot, and concurrent conditions included hypertension, hypocholesteremia, and migraines. The patient was previously treated with Lisinopril, Atorvastatin, Zonisamide for migraine, Tizanidine for muscle pain related to migraine, Promethazine, Ketorolac, Trazodone for sleep, Influenza vaccine (Flu shot); and experienced drug allergy when treated with Epinephrine for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered 01 total, on 17-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, about 15 minutes after vaccination, the patient experienced tingling face for 5 minutes, closing of throat about 5 mins but were airway clear, tongue swelling for few minutes, hot face, high blood pressure, high heart rate, and fever, was given Benadryl (diphenhydramine hydrochloride) 50mg IM (intramuscular) to right arm after 30 mins of vaccination. On 18-May-2021, the patient experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling face for 5 minutes, closing of throat about 5 mins but airway clear, tongue swelling few minutes, hot face, high blood pressure, and high heart rate on 17-MAY-2021, and had not recovered from fever, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210535640-COVID-19 VACCINE AD26.COV2.S-Tingling face for 5 minutes, closing of throat about 5 mins but airway clear, tongue swelling few minutes, hot face, and high heart rate . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20210535640-COVID-19 VACCINE AD26.COV2.S-High blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. V0 20210535640-COVID-19 VACCINE AD26.COV2.S-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Hypertension; Hypocholesteremia; Migraine

ID: 1336289
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/21/2021
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Symptoms: ARM HURT; This spontaneous report received from a patient and concerned a 42 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurt was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1336290
Sex: F
Age:
State: NJ

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

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Symptoms: LOW PLATELET COUNT; BLACK AND BLUES; This spontaneous report received from a concerned a 6 decade (age of patient (in late 50's early 60's) old female. The patient's weight, height, and medical history were not 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, consumer called to report that the patient got the vaccine and approximately 10 days later patient had black and blues and low platelet count. Patient was hospitalized and was still hospitalized on the day of reporting. Patient got a steroid and plasma treatment was used to successfully elevate platelets. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the black and blues and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210535373.; Sender's Comments: V0: 20210536558-JANSSEN COVID-19 VACCINE-Low platelet count, black and blues. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1336291
Sex: F
Age:
State: WI

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 05/21/2021
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Symptoms: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAY-2021, the subject experienced partial dose administered. The action taken with covid-19 vaccine was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1336292
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 05/21/2021
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Symptoms: ELEVATED BLOOD SUGAR LEVEL 446; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included the patient reported that he has 128-138 mg/dL as normal range for blood sugar. The patient was previously treated with prednisone for drug used for unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, 15 minutes after having lunch the patient experienced elevated blood sugar level 446 mg/dL. She reported that she had meatballs, butter noodles, and angel fruit cake with cabbage, also for beverage had ice-tea with no sugar. Laboratory data included: Blood sugar abnormal (NR: not provided) 446 mg/dL. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood sugar level 446 mg/dL. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210537343-Covid-19 vaccine ad26.cov2.s - Elevated blood sugar level 446. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.

Other Meds:

Current Illness: Diabetic

ID: 1336293
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 05/17/2021
Rec V Date: 05/21/2021
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Symptoms: FEEL STRONG IN THE MORNING; DIFFICULTY SLEEPING; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergy to chloroquine (difficulty sleeping, itching, fast heartbeat). The patient experienced drug allergy when treated with chloroquine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 04-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 17-MAY-2021, the subject experienced difficulty sleeping. On 18-MAY-2021, the subject experienced feel strong in the morning. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty sleeping, and the outcome of feel strong in the morning was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Diabetes (controlled with medications.); Hypertension (controlled with medications.); Non-smoker

ID: 1336294
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/21/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: FELT PAIN IN ALL OF JOINTS; NAUSEA TO THE POINT THAT COULD NOT EAT DINNER; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included back injury, back surgery, previous car accident, and rare case of chicken pox in mouth, and concurrent conditions included herniated disks, nerve damage, and low cholesterol level, and other pre-existing medical conditions included medical anomaly, high pain threshold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced felt pain in all of joints. On MAY-2021, the subject experienced nausea to the point that could not eat dinner. On MAY-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea to the point that could not eat dinner, felt pain in all of joints and soreness at injection site was not reported. This report was non-serious.

Other Meds:

Current Illness: Herniated disc; Nerve damage

ID: 1336295
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/16/2021
Rec V Date: 05/21/2021
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Symptoms: INNER LEFT ANKLE FELT HOT TO TOUCH; LEFT LEG PAIN; BULGING VEIN ON LEFT LEG; This spontaneous report received from a consumer concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced bulging vein on left leg. On 16-MAY-2021, the subject experienced left leg pain. On 19-MAY-2021, the subject experienced inner left ankle felt hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg pain, bulging vein on left leg, and inner left ankle felt hot to touch. This report was non-serious.

Other Meds:

Current Illness:

ID: 1336296
Sex: F
Age:
State: NJ

Vax Date: 02/15/2021
Onset Date: 03/01/2021
Rec V Date: 05/21/2021
Hospital: Y

Vax Type:
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Symptoms: Hospitalized with a major surgery/ Some blood leakage in brain; Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Brain operation in March 2021. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine). The patient was hospitalized on 01-Mar-2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) and PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. Patient had received the first dose of the Moderna Covid-19 vaccine and ended up being hospitalized in March with a major surgery that involved some blood leakage in brain. Patient had essentially missed the second Moderna Covid-19 dose scheduled in mid-March and at the time of reporting patient was about 90 days after receiving the first Moderna Covid-19 vaccine. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up received on 11-May-2021 Updated the Reporter, patient information and serious event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1336297
Sex: M
Age: 74
State: PA

Vax Date: 04/01/2021
Onset Date: 04/08/2021
Rec V Date: 05/21/2021
Hospital:

Vax Type:
Manufacturer:
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Allergies:

Symptom List:

Symptoms: Hallucination; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucination) had not resolved. No concomitant medications were provided. No treatment drugs were reported. It was reported that patient refuses to see a doctor and says that everyone else is crazy. Company comment: Limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09 May 2021 included no new information.; Sender's Comments: Limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1336298
Sex: M
Age: 75
State: AZ

Vax Date: 03/20/2021
Onset Date: 04/17/2021
Rec V Date: 05/21/2021
Hospital: Y

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Symptoms: Brain embolism; Missed second dose (51 days since first dose); Feeling a little weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL ARTERY EMBOLISM (Brain embolism) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced CEREBRAL ARTERY EMBOLISM (Brain embolism) (seriousness criteria hospitalization, medically significant and life threatening). On 09-May-2021, the patient experienced ASTHENIA (Feeling a little weak). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (51 days since first dose)). The patient was hospitalized until 08-May-2021 due to CEREBRAL ARTERY EMBOLISM. On 08-May-2021, CEREBRAL ARTERY EMBOLISM (Brain embolism) had resolved. At the time of the report, ASTHENIA (Feeling a little weak) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed second dose (51 days since first dose)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products included cholesterol medication, high blood pressure medication, anxiety medication, allergies medication, and medication for brain embolism. Company comment:This case concerns a 51-year-old male who experienced cerebral artery embolism and asthenia and missed second dose (51 days since first dose) (missed dose). Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events of cerebral embolism and asthenia, a causal relationship cannot be excluded. The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 51-year-old male who experienced cerebral artery embolism and asthenia and missed second dose (51 days since first dose) (missed dose). Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events of cerebral embolism and asthenia, a causal relationship cannot be excluded. The event of missed dose is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1336299
Sex: M
Age: 37
State: OH

Vax Date: 04/13/2021
Onset Date: 04/26/2021
Rec V Date: 05/21/2021
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Symptoms: Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On 07-May-2021, BELL'S PALSY (Bell's Palsy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Patient stated, he was given 2 medications of unknown names for treatment of bells palsy and symptoms gone way after a week of taking those meds. 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. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event start date, stop date and outcome updated. Vaccine given date updated.; Sender'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: 1336300
Sex: F
Age:
State: OH

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/21/2021
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Symptoms: acute anaphylactic shock; A.fib; blurry vision; swollen lips; Numbing sensation in her hands and lips; tingling sensation in her hands and lips; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (acute anaphylactic shock) and ATRIAL FIBRILLATION (A.fib) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ANAPHYLACTIC SHOCK (acute anaphylactic shock) (seriousness criterion medically significant), ATRIAL FIBRILLATION (A.fib) (seriousness criterion medically significant), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips). At the time of the report, ANAPHYLACTIC SHOCK (acute anaphylactic shock), ATRIAL FIBRILLATION (A.fib), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment for the events included diphenhydramine, metoclopramide, ketorolac, prochlorperazine and prednisone. The patient was advised not to receive the second dose of vaccine by her healthcare provider. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1336319
Sex: F
Age: 68
State: RI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 05/21/2021
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Allergies: NKA

Symptom List:

Symptoms: L arm sore x 3 days p # 1 injection L arm still painful after 14 days w/in 1 day L arm weak, throbbing unuseful. About 4-10 days after injection L arm unstable due to pain + profound weakness, Pain radiated to L shoulder and L neck trapezius + c spine. no relief ibuprofen, acetaminophen naproxen ( not taken until 7 days later did not want to blunt immune response). after 14 days L neck no longer painful, L arm pain improving. 2/26/21 - improving 1/19 - #1 1/20 - 1/23 sore arm 2/11 L arm weak, painful worsening daily max almost not usable 2/26 beginning to feel less pain + weakness - improving

Other Meds: Synthroid 137 mg daily Diltiazem 180 mg daily ER preparation Duloxetine 60 mg daily Sulfasalazine 1gm bid Folic acid 1 mg twice daily Methotrexate 20 mg once per week Hydroxychloroquine 400 mg daily Quetiapine 50 mg HS Timolol 0.5%

Current Illness: NONE

ID: 1336327
Sex: F
Age: 42
State: HI

Vax Date: 01/08/2021
Onset Date: 01/16/2021
Rec V Date: 05/21/2021
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Allergies: NONE

Symptom List:

Symptoms: Right EAR PAIN, NUMBNESS,TINGLING,BURNING TO HEAD, EAR , CHEEK, TOUNGE,(RIGHT SIDE) LIPS

Other Meds: NONE

Current Illness: NONE

ID: 1336343
Sex: F
Age: 77
State: TN

Vax Date: 01/25/2021
Onset Date: 02/03/2021
Rec V Date: 05/21/2021
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Symptoms: shot-1/25/21 Reaction started 2/3/21 Headache, arm swelling , rash spred From Shoulder to elbow. Soreness in chest + arm. as of 2/10/21 arm still red and not feeling good. Tired all the time hard to breath when in a hurry

Other Meds:

Current Illness:

ID: 1336459
Sex: F
Age: 51
State: PA

Vax Date: 04/06/2021
Onset Date: 05/03/2021
Rec V Date: 05/21/2021
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Allergies: MorphineHives / Urticaria

Symptom List:

Symptoms: Coordination Progress Note RN (Registered Nurse) COVID 19 Initial Patient Assessment Ordering Prescriber has completed required FDA EUA elements. COVID-19 Positive Result Date (and on chart/file): 05/05/2021 Start of Symptoms Date: 05/03/2021 Meets Criteria: ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease Reviewed present symptoms with patient. Congestion in head and chest, drainage, body aches, cough Purpose of Infusion Assessment: Can you tell me why you are receiving this infusion? Reviewed by Physician 1. Date/Time of Infusion: 5/10/2021 . Location of Infusion: A city: Come to address and while in your car, contact the Center to register over the phone from your vehicle. Once you are registered, you will be directed to the entrance and a nurse will be down to meet and assist you to the suite and infusion room ead congestion, Sinus congestion, sore throat, Mild Cough

Other Meds: Nervous Cervicalgia Chronic pain disorder Headache(784.0) Meningioma Other specified hemiplegia and hemiparesis affecting dominant side Atypical angina Respiratory Obstructive sleep apnea Circulatory Coronary artery disease Essential

Current Illness:

ID: 1336460
Sex: M
Age: 67
State: WA

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 05/21/2021
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Symptoms: Pt arrived to observation complaining of "a little short of breath" and "a little dizzy". VS within normal limits. EMS contacted and pt. cleared by EMS.

Other Meds:

Current Illness:

ID: 1336461
Sex: M
Age: 35
State: IN

Vax Date: 05/19/2021
Onset Date: 05/20/2021
Rec V Date: 05/21/2021
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Allergies: None

Symptom List:

Symptoms: Suffered from chills,nausea,fatigue,fever,headache,body ache.

Other Meds: Paxil,klonopin,fiber supplement,multivitamin

Current Illness: None

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm