VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

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

ID: 1161216
Sex: M
Age: 21
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Patient has anxiety over needles. He felt woozy after receiveing the vaccination so sat for quite awhile with a cold compress. He felt better after awhile and felt ready to leave. I called him an hour later to see how he was feeling and he said he felt completely fine.

Other Meds:

Current Illness:

ID: 1161217
Sex: M
Age: 58
State: TX

Vax Date: 03/29/2021
Onset Date: 04/02/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Anxiety, Dyspnoea

Symptoms: After having Covid vaccine for 4 days. Hives appear all over my body (chest, back, arms, legs, stomach).

Other Meds: Simvastatin; Levocetirizine

Current Illness: None

ID: 1161218
Sex: F
Age: 72
State:

Vax Date: 03/06/2021
Onset Date: 03/08/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: Codeine, Doxycycline, Sulfa, Contrast Media

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

Symptoms: Calf swelling and pain.

Other Meds: Pravastatin, Rivaroxaban

Current Illness:

ID: 1161219
Sex: F
Age: 50
State: FL

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: Codeine, Flexeril, Tetracycline, Amoxicillin, Penecillin, Sulfa, Percaset

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: at about 8 am I awoke very stuffy, mild headache and extreme body aches. By 10 am I had a fever of 98.9. I had extreme exhaustion all of the day. The following day I developed soft stool which went away. I took tylenol every 4 hours alternating it with Ibuprophen.

Other Meds: Aimovig, Gabapentin, Divaproex

Current Illness: Salmonella

ID: 1161220
Sex: F
Age: 28
State: AZ

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies: nucynta, cephalexin

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

Symptoms: Patient received vaccine at 9:10 am. Went to get a coffee, came back and stood in line, sat back down. At 9:25 am, called pt to counter to receive covid vaccination record card and id and she stated feeling dizzy. technician and pharmacist went out to assist, Pharmacist caught her as she passed out, technician pushed chair under her. We dragged chair into counseling room so that she could lay down on carpeted area. She was coherent - directed tech who to call, was able to describe how she felt (dizzy, nauseas).. She passed out for few seconds only. Ambulance was called when she was not feeling better. Ambulance arrived at 9:40am and left with patient at 9:53am. First bp taken 117/73, second bp upon sitting was 80/60 - at which point the paramedics recommended she be seen at hospital

Other Meds: Buprenorphine 8mg, ashlynia, hydrocodone/acetaminophen 5/325, atenolol 50mg, gabapentin 800mg, lisinopril hctz 20-12.5, sertraline 100mg, aripiprazole 10mg (newly started 6 days prior), albuterol inhaler.

Current Illness:

ID: 1161221
Sex: F
Age: 68
State: CO

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: Benadryl causes extreme agitation.

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

Symptoms: Low fever (99F), chills & constant shivering, dizziness, headache, mild nausea - all started about 12 hours after injection and lasted about 4 hours. It was difficult to get out of bed and walk without holding on to something. The next morning mild headache, tiredness, and weakness remained. Fever, shaking, dizziness returned the second evening but in milder form. Very sore arm started night of injection, gradually subsided over a few days.

Other Meds: Alendronate sodium;Escitalopram

Current Illness: None

ID: 1161222
Sex: F
Age: 83
State: NY

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

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

Lab Data:

Allergies: no known

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Patient received her Janssen COVID 19 vaccine at approximately 12:22pm and then was instructed to wait 15 minutes to be observed for adverse reactions. At the end of of her 15 minute observation approximately 12:37 she reported she was experiencing pounding in her ear.

Other Meds: Synthroid 137mcg, Torsemide 10mg, Sertraline 50mg, Losartan 50mg

Current Illness:

ID: 1161223
Sex: F
Age: 34
State: TX

Vax Date: 03/01/2021
Onset Date: 03/30/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: aloe vera, strawberries, and sumatriptan

Symptom List: Pharyngeal swelling

Symptoms: fever, chills, cold sweats, headache, body aches -- Tylenol and Avil

Other Meds: levothryoxine, phentrime, buproprion

Current Illness: Covid in February 2021

ID: 1161224
Sex: F
Age: 81
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Vaccine squirting outside needle hub. None in pt. Another dose given

Other Meds:

Current Illness:

ID: 1161225
Sex: F
Age: 42
State: CA

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

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

Lab Data:

Allergies: None

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Patient stated having dizziness and a ?wave of heat? sensation Patient turned car AC on and provided with water, patient stated symptoms resolved Patient seen by medical team , refused medical transport and signed AMA form

Other Meds: None

Current Illness:

ID: 1161226
Sex: M
Age: 47
State: VA

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Tinnitus I have an appointment with ENT next month.

Other Meds: None

Current Illness: None

ID: 1161227
Sex: F
Age: 56
State: MI

Vax Date: 03/17/2021
Onset Date: 03/24/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: Aspirin penicillin erythromycin

Symptom List: Rash, Urticaria

Symptoms: Red swollen itchy 3" circle at injection spot started 1 week after first dose. Lasted approx 48 hours

Other Meds: Synthroid

Current Illness: None

ID: 1161228
Sex: F
Age: 35
State: NE

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

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

Lab Data:

Allergies: CECLOR

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

Symptoms: Patient felt like she was going to faint, so we helped her move from the chair to the floor, bp was normal, 02 sat was 100, normal pulse, patient. Called 911 to have patient evaluated at the ER. Mother called after leaving the ER to say patient had a panic attack. According to mother ER physician advised the patient that she did not have a reaction to the Vaccine but had a panic attack. Mom stated that she thought she had grown out of having anxiety around needles etc.

Other Meds:

Current Illness:

ID: 1161229
Sex: F
Age: 52
State: PA

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

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

Lab Data:

Allergies: n/a

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

Symptoms: Numbness in hands, mouth, and head. Palpitations. Coughing. Couldn't open mouth. Tightness of chest and throat.-- around 10:00 am 2 benadryl 25 mg tabs, epipen in right thigh. was transferred to hospital at 10:30 am

Other Meds: n/a

Current Illness: n/a

ID: 1161230
Sex: F
Age: 60
State: OK

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Rapid heartbeat in short bursts for 5-30 seconds at a time. Got worse toward evening. Clocked at 140 beats per minute when it went long enough I could measure it. Same thing the next day.

Other Meds: Metoprolol, euthrox, eliquis, iron, vitamin d, omega 3, zinc, selenium, multivitamin, b complex.

Current Illness: None

ID: 1161231
Sex: M
Age: 63
State: WI

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 04/02/2021
Hospital: Y

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

Lab Data:

Allergies: No Known Drug allergies per patient

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

Symptoms: The patient stated he felt fine the day he received the vaccine. However, starting the day after, he developed dizziness, achiness and a headache. These symptoms progressively worsened over the course of several days. On day 6 after receiving the vaccine, the patient stated his right leg started dragging and he had a difficult time functioning. The patient drove himself to the ER where he collapsed. A bleed in the brain was subsequently discovered and the patient underwent surgery, where he spent 3 days in the ICU. The patient was later discharged. As of today, the patient states he has resumed normal function

Other Meds: Patient stated he is on a blood thinner (patient would not specify which one), metformin, atorvastatin and "blood pressure" medications

Current Illness: None reported by patient

ID: 1161232
Sex: F
Age: 30
State: TX

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Fever of 102.2, Nausea, Vomiting, Chills, Fatigue, Muscle Aches. Eventually went away after 24 hours.

Other Meds: None

Current Illness: None

ID: 1161233
Sex: F
Age: 65
State: WA

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: Allergies Gluten (Hives..) Wheat amide-type local anesthetics (Hives) ester-type local anesthetics (Hives) inhalation anesthetics (Hives..)

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Basic Information Chief Complaint Palpitations began at 0940 today, Hx SVT, received second dose of Moderna vaccine yesterday History of Present Illness 65F with hypothyroidism and hx of SVT, who presents with palpitations. She has had palpitations reportedly since childhood and has documented SVT on cardiac monitor in 3/2017. At baseline she has palpitations 1-4x per month, but she has had more frequent palpitations since receiving the COVID vaccine earlier this month. 2nd COVID dose yesterday. Today her palpitaitons lasted 1.5 hours prompting her to present to ED. She is asymptomatic aside from palpitations. No lightheadedness, syncope, chest pain, SOB, N/V, diaphoresis. No leg swelling. She is able to walk around while having palpitations. She does not take rate control agents or anticoagulation. She has plans to see her ARNP for outpatient cardiac monitoring in mid April.

Other Meds: Home 5-HTP 100 mg oral capsule, 100 mg= 1 cap(s), PO, Every Bedtime AR-Encaps, 2 tablets po prn pain Biomins II, 2 capsules po BID biotin 1000 mcg oral tablet, 5000 mcg= 5 tab(s), PO, Daily Calcium and Magnesium oral tablet, 1 tab(s),

Current Illness:

ID: 1161234
Sex: F
Age: 54
State:

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: Amoxycillin

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: 7 hours after vaccination took place, I developed a headache and then became really cold. I got colder and colder and then started to shiver and couldn't stop. My husband reported that I was really hot. I continued to shake for about 2 hours when I finally fell asleep. The next day, I continued to have a headache and lacked energy. I still felt I had a temperature but not as extreme as overnight. I took paracetamol every 4 hours to combat the feeling of being unwell and had frequent lie-down breaks. I woke up today feeling well enough to go about my household chores whilst still feeling unwell. I still feel quite tired and have a slight temperature. After my evening meal, I had an upset stomach which led to diarrhoea.

Other Meds: 20mg Simvastatin

Current Illness: General cold symptoms prior to taking vaccination.

ID: 1161235
Sex: F
Age: 77
State: MN

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

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

Lab Data:

Allergies: Oral Medications and food allergies

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

Symptoms: Gave the Vaccine at 12:42 client waited 18-20 minutes stood up to walk back to apartment and stated that she was not feeling well and sat back down. Stated that she was feeling short of breath and was not seeing clearling. Writer instructed Office support to call 911. Client continued to have heavy breating and pulse was weak at about 30 beats per minute. Gave epinephrine injection in Right thigh and EMS arrived. Client increased respirations and heart rate increased.

Other Meds: unknowen

Current Illness: None known

ID: 1161236
Sex: F
Age: 67
State: CO

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: None that I know of

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

Symptoms: Severe side effects began at midnight (after the 2nd dose was received at 3:45 in the afternoon) that included headache, fever, chills, fatigue, nausea, joint pain, and muscle pain that lasted over 6 hours. Phoned triage nurse who set me up with an alternating regimen of ibuprofen and acetaminophen. Muscle & joint pain subsided quickly. Fever & chills left were next to go . Headache, fatigue & nausea stuck around until the afternoon (almost 24 hours after the vaccination) .

Other Meds: Metrocream; multi vitamin, B12;, Glucosamine MSM; fish oil, calcium w/vit D , Biotin,, Vitamin C, Vitamin D, Vitamin E

Current Illness: None

ID: 1161237
Sex: M
Age: 58
State: PA

Vax Date: 03/26/2021
Onset Date: 03/31/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies: Poison ivy.

Symptom List: Unevaluable event

Symptoms: 1 day after vaccination - chills, fever, headache. 5 to 7 days after vaccination - inguinal lymphadenopathy and penile edema (Physician description)

Other Meds: amlodipine, apixaban, fish oil tablets, fluticasone nasal spray.

Current Illness: None

ID: 1161238
Sex: F
Age: 52
State: SC

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

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

Lab Data:

Allergies:

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

Symptoms: Patient developed swelling and redness from the injection site down to the wrist of the left arm. This occurred within 10 minutes of injection and was resolved with 50 mg of benadryl within 12 minutes after administration. All symptoms resolved and patient was counseled on signs of anaphylaxis. Patient was observed for 15 additional minutes prior to being dismissed with husband.

Other Meds:

Current Illness:

ID: 1161239
Sex: F
Age: 35
State: WI

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

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

Lab Data:

Allergies: Bactrim

Symptom List: Injection site pain, Pain

Symptoms: Symptoms started upon wakening the morning after getting the Moderna vaccine. Symptoms include a headache, nausea, fever/chills, and pain at injection site. Vitals stable.

Other Meds: Atorvastatin 10 mg HS, Insulin isophane (NPH) SQ 4 units AM/PM,

Current Illness:

ID: 1161914
Sex: U
Age: 72
State: VA

Vax Date: 04/04/2016
Onset Date:
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-APR-2016, the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1161916
Sex: F
Age:
State: NE

Vax Date: 04/21/1994
Onset Date: 05/01/1994
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she started having seizures / still currently gets seizures; This spontaneous report as received from a patient's mother refers to a currently 28-year-old female patient. Her concurrent conditions included hypothyroidism. The patient's concomitant therapies included methsuximide (CELONTIN), levetiracetam(KEPPRA) and "Selbatol". There was no information regarding her medical history. The patient had none drug reactions or allergies. On an unknown date, the patient was was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis, without any reactions. On 21-APR-1994, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot# 1603W has been verified to be not valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (dose, route of administration and expiration date were not reported) for vaccination. On the same date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis. On 01-MAY-1994, the patient started having seizures. She still currently got seizures and was taking seizure medications. The patient did not have seizures prior to taking the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient sought medical attention on an unknown date. The reporter stated that she reported this in the past (initial version was not found). The outcome of seizure was reported as not recovered. The causality assessment between the events and the suspect therapies was not provided. Upon internal review, the event of seizures was determined to be medically significant.

Other Meds: CELONTIN; KEPPRA

Current Illness: Hypothyroidism

ID: 1161917
Sex: F
Age: 66
State: IL

Vax Date: 11/18/2020
Onset Date: 11/01/2020
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: swelling, warmth and redness from shoulder to elbow of left arm; swelling, warmth and redness from shoulder to elbow of left arm; swelling, warmth and redness from shoulder to elbow of left arm; This spontaneous report was received from a 66-year-old non-pregnant female patient, who was referring to herself. She has no pertinent medical history and no drug reactions/allergies. On 18-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliter, intramuscularly (strength, lot number and expiry date were not reported) for prophylaxis. Concomitant vaccinations included flu shot given on the same day. On an unspecified date in November 2020 (approximately 5 hours after receiving the suspect vaccine), the patient experienced swelling, warmth and redness from shoulder to elbow of left arm. The events lasted for several days. No treatment was given to the patient. No lab diagnostics/tests were performed. The patient did not seek medical attention. On an unknown date (reported as couple of days after), the patient recovered from the events. The relatedness between the events and the suspected vaccine was not reported.

Other Meds:

Current Illness:

ID: 1161921
Sex: F
Age:
State: TN

Vax Date: 03/01/2018
Onset Date:
Rec V Date: 04/02/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: her heart went back into afib one; feeling tired; numbness in her hands and fingers; tingling in her hands and fingers; lower back pain on the right side/lower back starts to hurt sometimes; weakness in legs/legs are weak; shortness of breath; feeling off; black eye; This is an initial solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer. This 79-year-old female patient was involved in a patient support program. The patient received apixaban. The report describes a case of fatigue (feeling tired), hypoaesthesia (numbness in her hands and fingers), paraesthesia (tingling in her hands and fingers), back pain (lower back pain on the right side/lower back starts to hurt sometimes) and muscular weakness (weakness in legs/legs are weak). The occurrence of additional non-serious events is detailed below. The patient's past medical history included High frequency ablation and Hospitalisation. In March 2018, the patient started apixaban (Oral), (unspecified dose, twice a day). On an unknown date, the patient experienced fatigue (feeling tired), hypoaesthesia (numbness in her hands and fingers), paraesthesia (tingling in her hands and fingers), back pain (lower back pain on the right side/lower back starts to hurt sometimes), muscular weakness (weakness in legs/legs are weak), dyspnoea (shortness of breath) and feeling abnormal (feeling off). The action taken with apixaban (Oral) was unknown. At the time of the report, fatigue, hypoaesthesia, paraesthesia, back pain, muscular weakness, dyspnoea and feeling abnormal outcome was unknown. For apixaban (Oral), the reporter did not provide any causality assessments. Patient received apixaban for the indication of Atrial fibrillation. The consumer reported that in Mar-2018 during a trip with her daughter, she began feeling tired and her legs hurt. When she returned home, she was hospitalized and diagnosed with Atrial Fibrillation. Follow-up (18Mar2021): This is a follow-up solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer license party for apixaban. This 79-year-old female patient was involved in a patient support program. The patient received APIXABAN. The report describes a case of ATRIAL FIBRILLATION (her heart went back into afib one). The occurrence of additional non-serious events is detailed below Co-suspect products included Covid-19 Vaccine. The patient's past medical history included High frequency ablation and Hospitalization. Concurrent medical conditions included AFib. In March 2018, the patient started APIXABAN (Oral), (unspecified dose, twice a day). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seriousness criterion medically significant), FATIGUE (feeling tired), HYPOAESTHESIA (numbness in her hands and fingers), PARAESTHESIA (tingling in her hands and fingers), BACK PAIN (lower back pain on the right side/lower back starts to hurt sometimes), MUSCULAR WEAKNESS (weakness in legs/legs are weak), DYSPNOEA (shortness of breath), FEELING ABNORMAL (feeling off) and EYE CONTUSION (black eye). The patient was treated with Surgery (heart monitor) for Atrial fibrillation. The action taken with APIXABAN(Oral) was unknown. At the time of the report, ATRIAL FIBRILLATION, FATIGUE, HYPOAESTHESIA, PARAESTHESIA, BACK PAIN, MUSCULAR WEAKNESS, DYSPNOEA, FEELING ABNORMAL and EYE CONTUSION outcome was unknown. The patient stated that she had the coronavirus Pfizer vaccine and a few days later she had a black eye. The patient was concerned about this because she takes Eliquis so she asked a healthcare professional for advice they then informed her that the vaccine had caused her black eye. She was told that she cannot miss her second vaccine and that she might have to stop Eliquis. Patient was concerned about having to stop and had some questions. The patient reported that, she had been on Eliquis for a while and she had been doing just fine. She recently took the Pfizer Covid vaccine and a week or two later she developed a "black eye". She described the color around her eye as eggplant purple. She remembered her mother would have blood vessels burst around her eye, so at first, she thought nothing of it. She said the day before yesterday she went with her daughter while she got the Moderna Covid vaccine. She asked the nurse administering her daughters Moderna Covid vaccine if the Pfizer vaccine could cause black eyes. The patient said the nurse did some research and told her the the Pfizer vaccine was known to cause hemorrhaging, and that the vaccine caused the black eye. The nurse told the patient she should go to her HCP as soon as possible and get blood work done. The patient did not say anything else was abnormal about her blood work. She told the HCP what happened to her eye after she was given the Pfizer Covid vaccine. The HCP told her that no matter what the patient should get the second Pfizer vaccine, even if she had to stop the Eliquis for a few days. The patient said she did not want to stop the Eliquis because she has been doing wonderful on the medication and did not think the Eliquis was the cause of the black eye. She said she will have a talk with her normal primary care doctor as well as her cardiologist. The patient said she rather not get the second covid then stop the Eliquis. The patient started Eliquis two years ago after her heart went into "full afib" she had an ablation procedure and they shocked her heart three times to get it back into rhythm. Since starting the Eliquis the patient said her heart went back into afib one time. She wore a heart monitor and her heart went back into sinus rhythm on its own. She also mentioned that her HCP prescribed her a diuretic but she said she has a terrible reaction to it. She was prescribed the diuretic to help with the swelling around her ankles. She said the diuretic was also to help "keep congestion from her heart". The diuretic makes her feel "terrible" so her HCP allows her to cut the pill in half or quarters and take as needed to keep swelling down. She said the diuretic makes her feel faint and she even passed out one time while walking in the mall. She said she has not taken it in a while. The patient said she had a lot of allergies to medications, to many to list. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Prothrombin time: 16.2 seconds. For APIXABAN(Oral), the reporter did not provide any causality assessments. Patient received apixaban for the indication of Atrial fibrillation. The consumer reported that in Mar-2018 during a trip with her daughter, she began feeling tired and her legs hurt. When she returned home, she was hospitalized and diagnosed with Atrial Fibrillation. The strength of Eliquis was 5 mg. Most recent follow up information received on 18-Mar-2021 from Non-Health Professional incorporated above includes : New events added, lad data, concomitant drugs and narrative updated.; Sender's Comments: BMS Medical Evaluation Comment: This 79-year-old patient had atrial fibrillation after therapy with apixaban. Elderly age and underlying atrial fibrillation can be associated with increased risk of arrhythmias and based on the absence of etiological plausibility; the reported event is considered not related to apixaban.

Other Meds: POTASSIUM; CHLORTALIDONE; VITAMINS NOS; PROBIOTICS NOS

Current Illness: AFib

ID: 1161925
Sex: F
Age: 67
State: FL

Vax Date: 08/25/2020
Onset Date:
Rec V Date: 04/02/2021
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Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Bilateral Sensorineural Hearing Loss; Bilateral Tinnitus; Right ear pain; Pressure on ears; This case was reported by a lawyer and described the occurrence of sensorineural hearing loss in a 56-year-old female patient who received Herpes zoster (Shingrix) for muscle pain. The initial information was received on 31 March 2021 via medical record (case is now medically confirmed). The current condition includes Nonsmoker, Patient suffered with Bilateral Sensorineural Hearing Loss and Bilateral Tinnitus. The patient was used Shingrix 0.5 ml via Intramuscular route on 27 August 2020. According to MR patient had odynophagia (pain while swallowing) Patient was reported since August 25 had series of adverse effects includes loss hearing and tinnitus, later she experienced terrible pressure on her ear.

Other Meds:

Current Illness: Pre-diabetes

ID: 1161927
Sex: F
Age:
State: UT

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

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Symptom List: Nausea

Symptoms: SWOLLEN THROAT; HEART RACING; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 220 kilograms, and height was 54 inches. The patient's past medical history included hormone replacement therapy, and concurrent conditions included thyroid disorder, anxiety, depression, arthritis, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies or history of drug abuse or illicit drug usage. The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: Unknown) dose not reported, on 04-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that the patient was on unspecified hormone replacement therapy medication, thyroid medication, a blood thinner ,antianxiety and antidepressant medications, pre diabetes medications, and arthritis medication. On 04-MAR-2021, the subject experienced swollen throat and heart racing and was admitted to emergency room. On 04-MAR-2021, the subject also experienced headache. No further information provided. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-MAR-2021, and had not recovered from swollen throat, and heart racing. The reporter assessed the events as related to COVID-19 vaccine AD26.COV2.S This report was serious (Hospitalization Caused / Prolonged) for swollen throat and heart racing.; Sender's Comments: Swollen throat, headache and heart racing . This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness: Abstains from alcohol; Anxiety; Arthritis; Depression; Hormone replacement therapy; Non-smoker; Thyroid disorder

ID: 1161928
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
Hospital:

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Symptom List: Injection site pain

Symptoms: CHEST TIGHTNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol use (socially), no smoking, and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021;11:00 am, into left arm, for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced chest tightness and shortness of breath. Patient complained of chest tightness which began approx. 2 min after injection. Patient also stated that he had to breathe slowly and "not heavy", and felt short of breath. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient had not recovered from chest tightness, and shortness of breath. This report was serious (Other Medically Important Condition).; Sender's Comments: Chest tightness, and shortness of breath. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness: Alcohol use (Socially); Nonsmoker; Pollen allergy

ID: 1161929
Sex: U
Age:
State: MN

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
Hospital:

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

Symptoms: VOMITING; SEVERE SHAKING; HIGH HEART RATE; FEVER OVER 100.2; This spontaneous report received from a health care professional . The patient's weight, height, and medical history were not reported. It was not asked if the patient had any allergies. It was unknown if the patient consume alcohol, smoke and if there was any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 04.45 pm, vaccination site not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced vomiting, severe shaking, high heart rate, and fever over 100.2. Patient was given injection around 4.45 pm on 05-MAR-2021 and adverse events of severe shaking, fever over 100.2, high heart rate and vomiting started about 45 minutes ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, severe shaking, and fever over 100.2, and the outcome of high heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Vomiting, severe shaking, high heart rate, and fever over 100.2.. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161930
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 03/05/2021
Rec V Date: 04/02/2021
Hospital:

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

Symptoms: INCREASED HEART RATE; BREATHING INCREASE; This spontaneous report received from a patient concerned an 85 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 08:40 am, into left arm, for covid-19 prevention. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the patient experienced increased heart rate and breathing increase. Patient had covid screening a couple of days ago and it was negative. Patient reported that she got the shot at about 20 minutes to 9 am today and was fine till after dinner around 1:30 and her heart rate increased by 10 beats per minute (bpm) and she had increased breathing. Patient wanted to know if that was a bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and breathing increase on 05-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: Increased heart rate, and breathing increase. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161931
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
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Symptom List: Tremor

Symptoms: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021, vaccination site was not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced fever. Patient reported that she received the covid vaccination last night around midnight. Next morning patient started to have a fever. Patient was referred to seek medical advice from health care practitioner as patient asked what she should take for fever, as health care practitioner know her medical history. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: Pyrexia. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1161933
Sex: M
Age:
State: UT

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
Hospital:

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Symptom List: Erythema, Pruritus

Symptoms: DIFFICULTY BREATHING; FAST HEARTBEAT; DIZZINESS; WEAKNESS; WEIRD FEELING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to Left Arm for covid-19 vaccination. No concomitant medications were reported. On 06-MAR-2021 (at night), the patient experienced difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. Symptoms have not worsened or improved since onset. The patient stated that "he doesn't feel that bad, but feels weird, like he is in the water." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling (outcome also reported as unknown). This report was serious (Other Medically Important Condition).; Sender's Comments: Difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161934
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 03/05/2021
Rec V Date: 04/02/2021
Hospital:

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Allergies:

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

Symptoms: FEVER; HEART RATE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route and batch number: Unknown) dose was not reported, administered on 05-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced fever and heart rate increased. Her heart rate was115 beats per minute even at rest. Treatment medications included paracetamol for fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart rate increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Fever and heart rate increased. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161936
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/02/2021
Hospital:

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

Symptoms: PASSED OUT; LIGHT HEADED; SHIVERING; HARD TIME REGULATING ITS TEMPERATURE; SENSITIVE SKIN; This spontaneous report received from a female of unspecified age reporting on self via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sensitive skin. On an unspecified date, the patient stated that the side effects for her were bad but short lived, got light headed and passed out in her kitchen, if she felt light headed, sat or lay down so she could not fall, her body also had a hard time regulating its temperature (temperature regulation disorder). The patient was shivering uncontrollably for about an hour, and then overheated very quickly under all blankets. On 11-MAR-2021 the patient mentioned that her skin feel sensitive, otherwise she was fine. She got the shot yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, was recovering from shivering, and sensitive skin, the outcome of passed out and temperature regulation disorder was not reported. The reporter considered the causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder as related. Company causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder was possible This report was serious (Other Medically Important Condition).; Sender's Comments: 20210322217-JANSSEN COVID-19 VACCINE-Passed out. This event is considered unassessable. 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: 1161937
Sex: F
Age:
State: NV

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

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Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: SEIZURE; FLU LIKE SYMPTOMS (CHILLS, HIGH TEMPERATURE, FEELS HOT,STUFFY NOSE); This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported. On MAR-2021,On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which is subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine, including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210322863-Covid-19 Vaccine Ad26.Cov2.S-Seizure. This event is considered Unassessable. 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: 1161938
Sex: M
Age:
State:

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

Vax Type:
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Allergies:

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

Symptoms: UNABLE TO ACHIEVE OR MAINTAIN AN ERECTION; FEMINIZATION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S)(suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in MAR-2021, the patient was unable to achieve or maintain an erection as well as feminization (making him 5'3" and giving him small hands). The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of the unable to achieve or maintain an erection and feminization was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review, the following information was amended: outcome was updated from possible to not reported in narrative. Null flavor unknown selected for batch no.; Sender's Comments: v1: Version created to amend outcome in narrative. 20210324270-Covid-19 vaccine ad26.cov2.s-Erectile dysfunction. This event is considered unassessable. 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: 1161939
Sex: U
Age:
State: VA

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: FAINTING; LOSS OF CONSCIOUSNESS; HYPOTENSION; This spontaneous report received from a health care professional concerned multiple patients. Initial information was processed along with the additional information received on 17-MAR-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The nurse reported on 11-MAR-2021. two patients had hypotensive episodes and fainted in clinic. On 11-MAR-2021, the patients experienced loss of consciousness. On an unspecified date, the patients had fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of consciousness, hypotension and fainting was not reported. The reporter provided causality between covid-19 vaccine ad26.cov2.s and loss of consciousness, hypotension, fainting was possible. This report was serious (Other Medically Important Condition).; Reporter's Comments: This case contains multiple patients.; Sender's Comments: V0: 20210324277- Covid-19 vaccine ad26.cov2.S- loss of consciousness, hypotension, fainting. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds:

Current Illness:

ID: 1161941
Sex: M
Age:
State: LA

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 04/02/2021
Hospital:

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Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: FELT BILATERAL LUNG CONGESTION; BILATERAL SIDE PAIN; VOMITING; DIFFICULTY BREATHING; PAIN WHEN BREATHS; FEVER OF 100 F; FATIGUE; MISSED WORK TODAY; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain), vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration). Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210325415- Covid-19 vaccine ad26.cov2.S- bilateral lung congestion. This event is considered unassessable. 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: 1161942
Sex: M
Age:
State: AR

Vax Date:
Onset Date: 03/09/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: RASH ON ARMS AND HANDS; EXTREME PAIN IN BOTH HANDS AND ARMS; SEIZURE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is not on any medication and has no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. patient got the Janssen Covid shot on March 9th Tuesday and then experienced headache started same day and Wednesday10th march, took Tylenol and headache recovered, then seizure on 11th mar, went to the ER and spoke to the doctor on reporting day. consumer also started patient experiencing rash and extreme pain on both arms and hands on reporting day 12th mar and getting worse. On 09-MAR-2021, the subject experienced headache Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and headache, and had not recovered from rash on arms and hands, and extreme pain in both hands and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210325468 - Covid-19 Vaccine Ad26.Cov2.S - Seizure. This event is considered Unassessable. 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: 1161944
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: FEELS BAD; Initial information received on 03-MAR-2021 was processed with additional information received on 09-MAR-2021. The case was reassessed as serious based upon new information received on 09-MAR-2021. This spontaneous case was received from a patient and concerned a 76 year old female. The patient's weight was reported as 90 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received treatment with COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported; the Company is unable to perform follow-up to request batch/lot numbers), dose was not reported for prophylactic vaccination on 02-MAR-2021. The concomitant medications included macitentan and apixaban. On 03-MAR-2021, the patient reported feeling bad after taking the COVID shot and was considering going to the hospital. On an unspecified date in MAR-2021, the patient was hospitalized. No details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels bad was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210108619.; Sender's Comments: V0 A 76-year-old female patient reported feeling bad next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of administration not reported) for prophylactic vaccination. The patient's concurrent conditions included pulmonary arterial hypertension. concomitant medications, and details of the event were not reported. On an unspecified date the patient was hospitalized. This case has insufficient information to make a meaningful medical assessment.

Other Meds: ELIQUIS; MACITENTAN

Current Illness: Pulmonary arterial hypertension

ID: 1161946
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DEHYDRATED/ DIZZY SPELLS IN MORNING; VERTIGO; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 238 pounds, and height was 155.7 centimeters. The patient's concurrent conditions included abstains from alcohol, non-smoker, and cholesterol, and other pre-existing medical conditions included no known allergy and no history of drug abuse. 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 09-MAR-2021 13:00 at left arm for prophylactic vaccination. The batch number was not reported in follow-up information. Concomitant medications included atorvastatin to control cholesterol. On 10-MAR-2021, the patient experienced vertigo. On 12-MAR-2021, the patient was dehydrated (dizzy spells) in morning. And patient took IV treatment for dehydration. Laboratory data (dates unspecified) included: Blood test (NR: not provided) all good. It was reported that the patient was not ill at the time of vaccination. The patient did not have pre-existing acute illness 30 days prior to vaccination. The patient did not have history of hospitalization in last 30 days prior to vaccination. The patient did not have any family history of any disease (relevant to vaccination) or allergy. It was also stated that the product was properly stored from receipt to administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, and the outcome of dehydrated/ dizzy spells in morning was not reported. This report was serious (Other Medically Important Condition). Additional information was received as follow-up 30/MAR/2021. The following information was updated and incorporated into the case narrative: Patient demographic (height, weight, age), medical history, lab test, reporter (contact), concomitant medication, event of dehydration/dizzy spell in morning and administered IV treatment for dehydration.; Sender's Comments: V1 20210327793-covid-19 vaccine ad26.cov2.s.-Dehydration. This event is considered unassessable. 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: ATORVASTATIN

Current Illness: Abstains from alcohol; Blood cholesterol abnormal; Non-smoker

ID: 1161947
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: STROKE; BLINDNESS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested On MAR-2021, the subject experienced stroke. On MAR-2021, the subject experienced blindness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blindness was not reported. The reporter did not report causality between covid-19 vaccine ad26.cov2.s and stroke ,blindness .Company causality between covid-19 vaccine ad26.cov2.s and stroke and blindness was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210331088-Covid-19 vaccine ad26.cov2.s-Stroke , Blindness. 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: 1161948
Sex: M
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: SEIZURE; This spontaneous report received from a consumer concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, after administration of vaccine the patient started having a seizure and ended up going to hospital (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210333412 - JANSSEN COVID-19 VACCINE Ad26.COV2.S - Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161949
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 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 not reported, batch number: UNKNOWN, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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: 1161950
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: BLOOD SUGAR LEVEL INCREASED; VOMITING 10 TIMES; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included type-1 diabetes for last 32 years, taking insulin Humalog 15 iu bd and Lancetan 40 iu once daily, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use, no alcohol consumption and no smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609) dose was not reported, frequency 1 total, administered on 20-MAR-2021 09:00 for prophylactic vaccination on right arm. Concomitant medications included insulin lispro for type 1 diabetes, and plantago major extract. Blood Sugar level was tested on (Saturday) March 20, 2021 with test result 86, (Sunday) March 21, 2021 with test result 79 and 106 and (Monday morning at 7 am) March 22, 2021 with test result 286 On 22-MAR-2021, the patient experienced blood sugar level increased. On 22-MAR-2021, the patient experienced vomiting, chills, nausea and headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the nausea, vomiting, headache, chills and blood sugar level increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210342051-COVID-19 VACCINE AD26.COV2.S - Blood Sugar Level Increased. 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: MEDICAL HISTORY.

Other Meds: LANCETAN; HUMALOG

Current Illness: Abstains from alcohol; Diabetes mellitus insulin-dependent (Type-1 Diabetic for last 32 yearsTaking Insulin Humalog 15 IU BD and Lancet 40 IU Once Daily); Non-smoker

ID: 1161951
Sex: U
Age:
State: NM

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTERED VACCINE OUT OF TEMPERATURE RANGE; This spontaneous report received from a pharmacist concerned multiple 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 admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The reporter stated that, on 22-MAR-2021, they administered 2 doses of product to the 2 patients at their facility, However these 2 doses was exposed at the room temperature for more than 2 hours recommended (10-15 mins past the recommended 2 hours) (administered vaccine out of temperature range). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine out of temperature range was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210343668-covid-19 vaccine ad26.cov2.s-administered vaccine out of temp range. 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: 1161952
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: WAS NOT ABLE TO WALK; NEUROLGICAL PROBLEMS WITH HIS LEGS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight was 90.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin. On an unspecified date, the patient experienced possible reaction to the Covid vaccine, patient was not able to walk and neurolgical problems with his legs. The patient was hospitalized since 14-MAR-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neurolgical problems with his legs and was not able to walk was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210132481, 20201218555, 20201109402, 20201033394, A-NJ2017-162166, A-US2016-145072, A-NJ2016-130161, A-US2015-129188, A-US2014-94192, A-US2019-188952 and A-NJ2014-109450.; Sender's Comments: V0: 20210343964-COVID-19 VACCINE AD26.COV2.S - Was Not Able To Walk, Neurological Problems With His Legs. 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: WARFARIN

Current Illness: Primary pulmonary hypertension

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am