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From the 4/30/2021 release of VAERS data:

Found 153,440 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 82 out of 1,535

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VAERS ID: 1251118 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Alaska  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dysgeusia, Dysmenorrhoea, Fatigue, Feeling abnormal, Heavy menstrual bleeding, Lymphadenopathy, Menstrual disorder, Nausea, Pain in extremity, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin d, c, e Multi vitamin Primrose oil
Current Illness: N/A
Preexisting Conditions: Dysplastic nevi (skin), acne, anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm pain, nausea, vertigo, extreme fatigue, fever (8 hours post vax, lasting 5 hours). Chills at same time as fever. Metallic taste in mouth day following immunization. Abnormal menstrual cycle (heavier, cramping), and shorter ovulation (only 9 days post- period start, versus usual 12). Swollen lymph nodes under arms. Brain fog (constant for two weeks following vaccine).


VAERS ID: 1251462 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Feeling abnormal, Flushing, Headache
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D3, Vitamin C, Multivitamin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 18 hours after shot -- began to have a headache, then 5 hours later (at 5pm) my face felt hot. I rarely have headaches. I checked my temperature, but it was in the normal range (98.3 degrees) I took Tylenol (2 pill), hydrated, ate dinner and slept. I felt ok the next day, just a little strange (hard to pinpoint issue ... but "off"). Took another 2-pill dose of Tylenol just in case.


VAERS ID: 1251577 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-02
Onset:2021-04-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood test, Joint swelling
SMQs:, Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Sulfa drugs
Diagnostic Lab Data: Blood tests taken on April 12th
CDC Split Type:

Write-up: Swelling of joints, especially knees and wrists but every joint in my body is sore. Started in my knees on April 9 then progressively got worse over the weekend. Saw doctor on Monday and they prescribed meloxicam. Went to er on Wednesday because condition wasn''t getting better and was in a lot of pain and they prescribed a steroid for 6 days. After 6 days and not feeling any better I contacted both the doctor and the er and never got a response. Very concerned at their lack of concern. Im not a doctor but I''m pretty sure you don''t just wake up with severe arthritis after never showing any symptoms? Really just need someone to assist me because I''m not getting better and its becoming extremely debilitating


VAERS ID: 1251779 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / N/A LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Cluster headache, Fatigue, Glycosylated haemoglobin decreased, Headache, Impaired work ability, Metabolic function test, Musculoskeletal chest pain, Myalgia, Pyrexia, Vitamin D decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: had labs - Dr sent me for a normal blood panel. I have received the results - the only findings were signs of possible of pre-diabetes which I never had heard - A1C level was low (email from doctor''s office). April 23, 2021: Dr. called after that - said it also showed Vit D level was very low - and he wanted me to start 2000 IU Vit D - which I have started. Will have follow up appt with Dr regarding these results.
CDC Split Type: vsafe

Write-up: That evening at 08:00 pm, I had chills, very slight fever (right under 100 degrees); fatigue. Saturday, I woke up without any of those symptoms but a terrible headache on Saturday morning - I had to go to work. It was severe enough for me to not go to work. Headache remained up until yesterday. The headache was pretty severe on Saturday, Sunday and I went to the doctor on Monday or Tuesday. I went because of the length of time of the headache. No meds were prescribed. They offered a brain scan which I decline based on the Dr''s explanation of what the scan really does. Dr told me to take Tylenol. It was a "cluster" headache - the right side of my head towards the low part of my neck. The headache was always at that location. Tylenol was enough to lower my headache from the moderate to a minor. I didn''t take much of it. I have not had a headache today for the first time since that Saturday. Muscle pain on my upper chest wall - it felt like I had been bench pressing - that symptom was on Wednesday and Thursday of last week (14th and 15th).


VAERS ID: 1251905 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Burning sensation, Computerised tomogram, Head discomfort, Magnetic resonance imaging, Myalgia, Pain of skin, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness: None
Preexisting Conditions: High cholesterol, tinnitis
Allergies: None know
Diagnostic Lab Data: Hospital ER for exam and CT, MRI and Bloodwork negative on April 20, 2021.
CDC Split Type:

Write-up: Burning and tingling pain on left side of head and face getting progressively worse. Hurts worse to move facial muscles or touch skin at area. No lesions.


VAERS ID: 1251931 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Allergies: Penicillins
Diagnostic Lab Data: Venous Ultrasound of right leg
CDC Split Type:

Write-up: Right peroneal vein DVT


VAERS ID: 1253980 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood magnesium, Blood pressure measurement, Blood test, Body temperature increased, Breast pain, Burning sensation, COVID-19, Diarrhoea, Dysphonia, Ear pain, Erythema, Feeling abnormal, Heart rate, Hyperglycaemia, Hyperhidrosis, Myalgia, Palpitations, Peripheral swelling, Red blood cell sedimentation rate
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN; FLUVOXAMINE; TRESIBA; VICTOZA; JANUVIA [SITAGLIPTIN]; LASIX [FUROSEMIDE]
Current Illness: Anxiety; Hypertension; Obesity; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Tick bite (The patient had a tick bite in November and was treated with unspecified antibiotics.); Comments: The patient was not pregnant at the time of report.
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Blood glucose; Result Unstructured Data: 258 (unit unspecified); Test Date: 20210412; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: 51 (unit unspecified); Test Date: 20210412; Test Name: Blood pressure; Result Unstructured Data: 157/95 mmHg; Test Date: 20210412; Test Name: Blood test; Result Unstructured Data: Negative; Test Date: 20210412; Test Name: Magnesium; Result Unstructured Data: Low; Test Date: 20210412; Test Name: Heart rate; Result Unstructured Data: 114 (unspecified unit); Test Date: 20210412; Test Name: Blood glucose; Result Unstructured Data: 230 (unit unspecified); Test Date: 20210412; Test Name: COVID-19; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210425219

Write-up: FELT RED STREAK UNDER ARM FROM SHOULDER; EAR PAIN ON RIGHT SIDE; HOARSE VOICE; LOOSE STOOLS; HYPERGLYCEMIA; SWEATING; LEFT BREAST BURNING; PALPITATIONS; LEFT ARMPIT BURNING; FELT RUN OVER BY A TRUCK; LEFT ARM SMELLS AND LOOKED LIKE AN AVACADO UNDER THE ARMPIT; TEMPERATURE 99.7-100.4; LEFT ARM DELTOID SORE/LEFT ARM SORE; This spontaneous report received from a patient concerned a 45 year female. The patient''s height, and weight were not reported. The patient''s past medical history included tick bite, and concurrent conditions included obesity, type 2 diabetes mellitus, hypertension, and anxiety. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 to left arm as prophylactic vaccination. Concomitant medications included fluvoxamine for anxiety, furosemide for hypertension, insulin degludec for type 2 diabetes mellitus, liraglutide for type 2 diabetes mellitus, sitagliptin for type 2 diabetes mellitus, and rosuvastatin. On 09-APR-2021, the patient experienced left arm smells and looked like an avacado under the armpit; she also felt run over by a truck. She had a temperature of 99.7-100.4 (unit unspecified) and had pain in left deltoid arm. On 10-APR-2021, the patient experienced palpitations, left armpit burning and left breast burning. On 11-APR-2021, the patient blood sugar was high 258 (unit unspecified) and experienced sweating and loose stools. On 12-APR-2021, the patient experienced ear pain on right side and had a hoarse voice. The patient had done lab tests at her physician''s office; her blood sugar was 230 (unit unspecified), had palpitations at 144 (unit unspecified) and blood pressure was 157/95 mmHg. She was tested negative for covid-19 and had a sedimentation rate of 51(unit unspecified); her magnesium was at low level. She also did an unspecified lab test for lyme disease and was negative. The patient was prescribed with Nystatin cream and nystatin powder and she also took paracetamol (Tylenol) with no relief. The patient felt that she had a red streak under her arm from her shoulder and was going back to her urgent care; she also called her endocrinologist regarding her hyperglycemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature 99.7-100.4 on 10-APR-2021, was recovering from left breast burning, left arm deltoid sore/left arm sore, sweating, and felt run over by a truck, had not recovered from left armpit burning, palpitations, hyperglycemia, ear pain on right side, loose stools, and left arm smells and looked like an avacado under the armpit, and the outcome of hoarse voice and felt red streak under arm from shoulder was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210425219 -COVID-19 VACCINE AD26.COV2.S-Hyperglycemia .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, UNDERLYING DISEASE


VAERS ID: 1254011 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Sluggishness
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had unspecified underlying conditions.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210444417

Write-up: SLUGGISH; POUNDING HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient had unspecified underlying conditions. 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-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 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced sluggish. On 10-APR-2021, the subject experienced pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding headache, fatigue and sluggish was not reported. This report was non-serious.


VAERS ID: 1255130 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-05
Onset:2021-04-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]
Current Illness: Allergy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021391222

Write-up: Right sided Bell''s Palsy Grade IV; This is a spontaneous report from a contactable physician. A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) intramuscular, administered in left arm on 15Mar2021 (at the age of 41-years-old) as SINGLE DOSE, dose and second dose was intramuscular, administered in left arm on 05Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 and ongoing allergies. Concomitant medication was Benadryl PRN for allergies. On 09Apr2021,the patient experienced right sided bell''s palsy grade iv. The patient underwent lab tests and procedures which included sars-cov-2 test was pending on 09Apr2021 Covid test type post vaccination done by nasal swab. Therapeutic measures were taken as a result of right sided bell''s palsy grade iv included Prednisone Taper and pain medication. The outcome of event was not recovered. Information about the Lot/batch number has been requested. ; Sender''s Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported event facial paralysis cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1255133 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic depression; Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021391286

Write-up: (name) had a seizure within 5 minutes or less of the first dose.; This is a spontaneous report from a contactable consumer or other non-HCP. A 16-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729) via an unspecified route of administration in Right Arm on 09Apr2021 00:30 as single dose for covid-19 immunization. Medical history included depression and seizure. The patient''s concomitant medications were not reported. On 09Apr2021 00:30, the patient had a seizure within 5 minutes or less of the first dose. Therapeutic measures were taken as a result of had a seizure within 5 minutes or less of the first dose. The outcome of event was recovering.


VAERS ID: 1255191 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Erythema, Hypotension, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FISH OIL; BENADRYL; ZYRTEC; MOTRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021392275

Write-up: She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0158), intramuscular, administered in left arm on 09Apr2021 16:30 as single dose for COVID-19 immunization. Medical history included 3 weeks of urticaria prior to vaccination. The patient has had no COVID history prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included fish oil; diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC); ibuprofen (MOTRIN), and an unspecified multivitamin. The patient previously took Amoxicillin and experienced drug allergies. After vaccine, the patient became very red, had dizziness, vomiting and diarrhea and hypotension on 09Apr2021. The events resulted in an emergency room/department or urgent care visit and hospitalization for 1 day. Treatment included epi, Benadryl, steroids, Pepcid, and fluid boluses. The outcome of the events was not resolved.


VAERS ID: 1255211 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Penicillin allergy (known allergies Yes allergic to penicillin only)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021392606

Write-up: Feeling Faint; Lightheadedness/dizziness; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EP7533, via an unspecified route of administration, administered in left arm on 07Apr2021 13:00 as single dose for Covid-19 immunisation. Medical history included Crohn''s disease, penicillin allergy. The patient was not pregnant at the time of vaccination. On 09Apr2021, the patient experienced feeling faint and lightheadedness/dizziness. No treatment information was provided. The outcome of the event was not recovered.


VAERS ID: 1255213 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6955 / 2 LA / OT

Administered by: Work       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Hypotension, Loss of consciousness, Oxygen saturation, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PROTONIX [OMEPRAZOLE]; LIPITOR [ATORVASTATIN CALCIUM]; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; AMLODIPINE BENAZEPRIL; CITALOPRAM; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: BP; Result Unstructured Data: Test Result:very low; Test Date: 20210409; Test Name: pulse ox; Result Unstructured Data: Test Result:99; Test Name: COVID test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: USPFIZER INC2021392644

Write-up: passed out/continued to drift in and out of conscientiousness; BP was very low; chest tightness; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via intramuscular route of administration on 09Apr2021 at 17:45 (at the age of 54 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stroke/heart attack from 2014 to an unknown date. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]); amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); citalopram; and clopidogrel. The patient previously took the first dose of BNT162B2 (lot number: EP6955) on 19Mar2021 (age: 54 years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. Patient had no known allergies. On 09Apr2021 at 18:00, after second vaccine was given, patient passed out. His wife was with him. He came to but continued to drift in and out of conscientiousness. His BP was very low, pulse ox 99. He also had chest tightness. Ambulance was called. He was stable till ambulance came and took him to hospital. The events resulted in emergency room/department or urgent care and hospitalization. Therapeutic measures were taken as a result of the events which included IV fluids, Tylenol and something was placed under his tongue for chest tightness. The patient had COVID test on an unspecified date with unknown results. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1255222 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9262 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Body temperature; Result Unstructured Data: Test Result:104; Comments: a fever of 104 last night; Test Date: 20210409; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC2021392781

Write-up: Fully vaccinated patient tested Covid-19 postive with full blown symptoms; Fully vaccinated patient tested Covid-19 postive with full blown symptoms; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EL9262) as a single dose; and dose 2 via an unspecified route of administration in the left arm on 09Feb2021 08:00 (Lot Number: EL1283) as a single dose for covid-19 immunisation. The medical history and concomitant medications of the patient were none. The patient was not diagnosed with covid-19 prior to vaccination. The patient has no known allergies. The patient did not have other vaccine in four weeks and did not have other medications in two weeks. The patient received the vaccine in a hospital. The patient reported that he was fully vaccinated on 09Feb2021. On Monday (05Apr2021), the patient mentioned that his two stepsons tested positive contracted it from their father that they saw on 01Apr2021. He further stated that his stepsons "interacted it house last week and they were tested positive Monday and Tuesday this week, this past week."He got tested on 09Apr2021 because he wanted to be safe for his restaurant employees and as a first responder. He was told he was positive. He mentioned that he had full blown symptoms and they said it''s unheard of they said I should report it. He got fever, congestion and cough. He further added that he had systems coughing, stuffy nose and a fever of 104 last night (09Apr2021) and shortness of breathe. The doctor''s office told him to reach out. This was very unusual. He inquired what do he do now, was he contagious, does he need 10-day quarantine even with the vaccine. The patient was Covid tested post vaccination with nasal swab rapid on 09Apr2021 with result of positive. It was reported that the treatment was unknown. The outcome of the events was unknown.


VAERS ID: 1255230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021392871

Write-up: anaphylactic shock and was transported to hospital ER/swollen lips and throat; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at a clinic. Medical history included allergic to penicillin and history of previous anaphylaxis reactions. The patient has no covid prior to vaccination. The patient''s concomitant medications were not reported. The patient previously took IV iron and experienced allergy. The patient received the vaccine at clinic and within 10 minutes, the patient experienced swollen lips and throat like anaphylactic shock and was transported to hospital ER. The patient received IV benadryl and Pepcid as treatment. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.


VAERS ID: 1255291 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021395010

Write-up: fainted; unconscious for a few minutes; This is a spontaneous report received from a contactable consumer (reporting on himself). A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration in in Arm Left on 09Apr2021 10:45 as single dose for COVID-19 immunization. The patient medical history was not reported and known allergies included Codeine, Abilify. The patient''s concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. Not tested COVID post vaccination. It was reported that 09Apr2021 11:00 patient fainted about a hour after getting home. Then the next day at approximately 2:45 she fainted again both times hitting the floor and laying unconscious for a few minutes. Patient had to go Emergency room and hospitalization for a few hours. The outcome of the events was recovered on an unspecified date. Information on the lot/ batch number has been requested.


VAERS ID: 1255345 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO; CLARITIN [CLARITHROMYCIN]; MELATONIN
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021397963

Write-up: There was blood in the stool and coming alongside the stool; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 08Apr2021 at 18:15 (batch/lot number: EW0153) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was not pregnant. The patient has no known allergies. Facility type vaccine was health clinic/facility. No other vaccine in four weeks. Concomitant medications included escitalopram oxalate (LEXAPRO), clarithromycin (CLARITIN) and melatonin; all taken for an unspecified indication, start and stop date were not reported. The patient experienced there was blood in the stool and coming alongside the stool on 09Apr2021 at 23:00 with outcome of not recovered. No treatment was received for the event. No Covid prior to vaccination and not Covid tested post vaccination.


VAERS ID: 1255472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Erythema, Rash macular, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021404037

Write-up: had immediate reaction of heavy chest; trouble breathing; tightness in her throat; Her blood pressure went up; her face was red; she had blotches on her arms; This is a spontaneous report received from Pfizer sponsored program COVAX SUPPORT. A contactable consumer (patient) reported a female patient of an unspecified age received BNT162B2 (BNT162B2) (Batch/Lot number was not reported), dose 1, intramuscularly on 09Apr2021 as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Apr2021 (reported as this morning), the patient had an immediate reaction of heavy chest, trouble breathing and tight in her throat following her first vaccination. Her blood pressure went up and her face was red and she had blotches on her arms. She stated she was immediately given Benadryl and took a hit from her inhaler and then was given another Benadryl. The patient stated they kept her there for 2 hours to make she would be alright. She stated the symptoms subsided but asked what she should do now. Clinical outcome of the events heavy chest, trouble breathing, tight in her throat, blood pressure went up, face was red and blotches on her arms was resolving. No follow up attempts are needed. No further information is expected.


VAERS ID: 1255476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: tested positive for COVID; Test Result: Positive
CDC Split Type: USPFIZER INC2021404173

Write-up: start feeling unwell after a few days, tested positive for COVID; start feeling unwell after a few days, tested positive for COVID; This is a spontaneous report from a contactable Nurse. A female patient of (3 decade) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unknown anatomical location on an unknown date at a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) for covid-19 immunisation. On 09Apr2021, patient start feeling unwell after a few days, tested positive for COVID. After the second dose, the patient started feeling unwell after a few days, tested positive for COVID, and a week after still tested positive for COVID. Event took place after use of product. The outcome of the events was unknown. Information on Lot and Batch number has been requested.


VAERS ID: 1255711 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Chills, Dyspnoea, Fatigue, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Sputum discoloured, Upper respiratory tract congestion, Wheezing, X-ray
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Peanut allergy (Known allergies: Peanuts)
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210415; Test Name: Nasal Swab; Test Result: Negative ; Test Name: X-rays; Result Unstructured Data: Test Result:normal
CDC Split Type: USPFIZER INC2021427502

Write-up: asthma acting up; fatigued; sore throat; congestion with green/brown mucus; congestion with green/brown mucus; chills; strong fever; started wheezing having slight asthma; couldn''t breathe; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included asthma and known allergies: peanuts. Concomitant medication included alprazolam, taken for an unspecified indication, start and stop date were not reported. On the First day of dose Friday 09Apr2021 9:00 am, patient felt fatigued only and it carried though until Monday night falling into Tuesday with a sore throat that kept getting worst so patient went for a COVID test and came back negative. Tuesday night patient self-medicated but was still feeling fatigued and woke up Wednesday fatigued as well as the extremely sore throat, congestion with green/brown mucus. Patient went to an urgent care got checked out and said this was a side effect. Later that night patient started getting the chills and came with a strong fever and started wheezing having slight asthma. Patient used rescue inhaler. Woke up Thursday morning, could not breathe due to asthma acting up and had not in 12 years. Patient used inhaler and it helped. Patient took a shower and had to cut it short because he could not breathe. He went and did a second COVID test and was negative. He also saw a doctor and took chest X-rays, said it was normal. Doctor said it was his asthma acting up most likely from the vaccine. Lab tests included Nasal Swab on 13Apr2021 and 15Apr2021 both were negative; X-rays on unknown date and was normal. It was reported that the events onset on 09Apr2021 at 12:00 pm. The events resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included asthma medication and steroid medication. Outcome of the events was resolving.


VAERS ID: 1255717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: covid-19 Test (Nasal swab); Test Result: Positive ; Comments: Wife tested positive as well
CDC Split Type: USPFIZER INC2021427949

Write-up: Wife tested positive as well; Wife tested positive as well; This is a spontaneous report from a non contactable consumer. A female patient of unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications was not reported. On 09Apr2021, the patient tested positive. The lab tests included PCR (Nasal swab), result: Positive on 09Apr2021. The outcome of the events was unknown. Follow-Up (14Apr2021): Upon follow up, new information included that the patient was vaccinated (first and second dose of vaccine was unknown.) No follow-up attempts are possible. No further information is expected.


VAERS ID: 1256117 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Epistaxis, Insomnia, Pain in extremity, Vision blurred
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Bloody nose Left leg / foot pain Entire left side of body not correct Chest pain Shortness of breath Blurred vision Can''t sleep


VAERS ID: 1256857 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Headache, Herpes zoster, Influenza like illness, Neuralgia, Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Effexor, Meloxicam, Estradiol, Medroxyproge, Vitamin D and B and fish oil.
Current Illness:
Preexisting Conditions: Lupus - Discoid
Allergies: Sulfa
Diagnostic Lab Data: CT scan to rule out blood clot. Blood work.
CDC Split Type:

Write-up: Had a headache within an hour, felt slightly flu-ish.. Developed a rash on my face on about day three. It kept getting worse and painful (swollen and near the eye) so I saw the doctor on April 16th. He treated me for shingles. The rash and pain was on the left side of my face and neck and in my hair. I felt better on about April 20th except the headache is still there and I still have nerve pain in my hair and one spot on the left side of my head, near my temple. It comes and goes.


VAERS ID: 1256906 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Fatigue, Heart rate increased, Sleep disorder, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: cashews, prednisone, bactrum, erythromycin
Diagnostic Lab Data: EKG blood panel troponin levels
CDC Split Type: VSAFE

Write-up: 4/9 vaccination. Twelve hours later, I had fast pulse over 130 BPM. Woke me up at night. My resting is at the low 60''s; normal. chest pain. I was so tired. Tried to go back to sleep. Kept having episode. I woke up husband and said we need to go to the ER. Ran tests. Referred to cardiologist. They gave me Tylenol and baby aspirin. *Went to ER 4/10 and 4/12 4/16 appt with cardiologist; 24 hour HR monitor. Waiting on results 4/26 Echocardiogram scheduled **Dr. (cardiologist)


VAERS ID: 1257193 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cold sweat, Dyspnoea, Fatigue, Feeling abnormal, Gait disturbance, Laboratory test, Limb discomfort, Muscle spasms, Muscle twitching, Pain, Pyrexia, Swelling, X-ray
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra, albuterol, Zomig, Emgality, Vitamins C and D, Magnesium, calcium, melatonion, zinc
Current Illness:
Preexisting Conditions: Asthma, allergies, eosinophilic esophagitis, chronic headache migraines
Allergies: Penicillin, cephalosporins, dairy, wheat, shrimp, clindamycin, septra, latex, bananas
Diagnostic Lab Data: Xrays and lab work have been done results have been with in normal limits
CDC Split Type:

Write-up: I woke up at 3 am Friday with cold sweats and body aches. Took 1000 mg Tylenol. Woke up again at 10:30 am to a fever still and this odd extremity feeling. Felt like I had a compression body suit on and weight of 50 pounds around my arms and legs, Mild shortness of breath. I felt like I was swollen but did not see any. I called my PCP and vaccine line and both nurses said go to the ER. I went to the ER they ran tests. The time of the ER I started getting leg cramping and spasming. Those symptoms continued to the weekend. On Sunday the weight and swelling feeling went away. I still had bad muscle cramping and swelling. I did telehealth on Tuesday with PCP and was given muscle relaxer which helped some throughout the rest of the week. Thursday night I have a temp pf 99.6 and went up to 100.6 on Friday morning. On Friday I became shortness of breath and fatigued. It became difficult to go up and down stairs or walking about 20 ft without difficulty breathing. I now have a lower right leg muscle twitch/spasm that comes and goes. I switched to a different PCP, he ran more blood work on Wednesday 4/21. And discussed the next steps for treatment and monitoring.


VAERS ID: 1257244 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Chest discomfort, Chest pain, Cough, Dysmenorrhoea, Dyspnoea, Fatigue, Immediate post-injection reaction, Injection site pain, Intermenstrual bleeding, Menstrual disorder, Menstruation delayed, Musculoskeletal stiffness, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Fertility disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Mushrooms
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1. Immediately following vaccination, pain at injections site, lasted 72 hours. 2. Twelve hours after vaccination - fatigue and muscle stiffness soreness in the lower back and legs, duration 12 hours. 3. Five days post vaccination, delayed onset of menstrual cycle. Spotting for 4 days when period was due. Severe cramps - unusual - waking up with pain and requiring pain relievers. Period began 5 days late. 4. Seven days post vaccination - chest tightness, with burning. Difficulty taking a deep breathe. Forced coughing while attempting to take a deep breath. This symptom is still persisting after nine days.


VAERS ID: 1257631 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Cough, Dysgeusia, Headache, Joint stiffness, Nasal congestion
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D,, 450 mg Wellbutrin, 20mg Celexa.
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Lactose
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Metallic taste right after injection. Two days later I had joint pain, headache with congestion and more use of my asthma inhaler. These are still on-going as well as tightness through the chest and shoulders. Some coughing.


VAERS ID: 1257879 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered, Syringe issue
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: No known illnesses
Preexisting Conditions: No known chronic conditions.
Allergies: No known Allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient did not receive entire dose of vaccine. Needle disconnected from the syringe, resulting in vaccine spillage. Unable, to contact patient to re-vaccinate. Staff responsible for incident has been retrained and educated.


VAERS ID: 1258647 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-26
Onset:2021-04-09
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram, Computerised tomogram, Full blood count, Headache, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multivitamin Daily omega fatty acid supplement
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: chem/CBC, CT and CTA
CDC Split Type:

Write-up: 04/19/2021 - 2 weeks post vaccine severe left sided headache and left sided visual disturbances - no previous history of migraines/ocular migraines


VAERS ID: 1258907 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-02
Onset:2021-04-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown which meds for those conditions
Current Illness:
Preexisting Conditions: High BP and high cholesterol
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pain all over her body, worse at night, has been worsening for the past week, notes a radiating pain that spreads and is much worse now than before has a pending appointment with a doctor tomorrow, no treatments at home Symptoms of muscle and body aches are subsiding gradually. Patient taking Benadryl and Tylenol as directed. Recommended to follow up with primary provider if symptoms worsen. I adv that given the onset time and duration may also be medical, especially if worsening rather than improving, agreed with dr visit given the current issues. Adv to try heating pad, can try any usual OTC pain relievers if desired as well according to recommended dosing. Adv to call back if issues worsen and we will FU on Wed. for outcomes of tomorrow''s PCP appointment and to see if more history can be gathered.


VAERS ID: 1259209 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Influenza like illness, Joint stiffness, Muscle tightness, Sleep disorder
SMQs:, Dystonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: supplements; calcium, magnesium, probiotic, melatonin
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: CT SCAN
CDC Split Type: VSAFE

Write-up: 4/9 vaccination About 5:30pm, I started to feel tight in neck and shoulders. Hour after that, felt flu like symptoms. Proceeded with chills that lasted all night long and into the next day. I could not sleep. One of the worse HA that lasted a few days. 4/14 Woke up thinking HA was gone. Still tired. 4/15 HA was back. Made appt on later date. met with PCM tele med.


VAERS ID: 1259704 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-02
Onset:2021-04-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Chest X-ray normal, Computerised tomogram thorax normal, Cough, Dyspnoea, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Percocet
Diagnostic Lab Data: Ultrasound done on leg April 23 rd. Blood test done on April 11th and April 23rd . Chest X-ray on April 11 th and cat scan on April 23rd
CDC Split Type:

Write-up: Went to er on April 11 th for cough and shortness of breathe they said nothing was wrong and sent me home. Did a virtual apt on 21st because my leg hurt and shortness of breathe. They told me to go see doctor in person . Went to Er April 23rd and was diagnosed with a massive blood clot in my lower right leg.they prescribed xarelto.


VAERS ID: 1260272 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-01
Onset:2021-04-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril Amlodipine Lipitor Fiber supplement Fish oil Melatonin
Current Illness: None
Preexisting Conditions: High blood pressure Cough Nodule of lung
Allergies: None
Diagnostic Lab Data: Ultrasound on 4/15 Advised to go to emergency room blood clot found Treated at ER and released
CDC Split Type:

Write-up: Soreness & lump in left lower thigh size of tic tac Swollen and sore left foot Diagnosed with ultrasound as superficial blood clot Heat applied and aspirin Still swollen


VAERS ID: 1260524 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Apathy, Blood test normal, Computerised tomogram normal, Confusional state, Decreased interest, Disturbance in attention, Dizziness, Dyslexia, Fatigue, Headache, Hypersomnia, Hypoaesthesia, Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Memory impairment, Nausea, Pain, Pain in extremity, Paraesthesia, Pyrexia, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Duloxetine, gabapentin, Adderall
Current Illness: N/A
Preexisting Conditions: ADHD, Depression, Anxiety
Allergies: Latex
Diagnostic Lab Data: CT Scan, IV Fluids, blood tests. Came out negative. 04/14/2021Hospital Follow-up visit, no tests 04/22/2021 Clinic
CDC Split Type:

Write-up: 04/07/2021 fatigue, low grade fever. 04/8/2021-04/14/2021 pain in injection site, fatigue, lack of interest, confusion, vision troubles, trouble understanding, nausea, dyslexia, dizziness, lightheaded, feeling of impeding doom, increased anxiety, headaches, body aches, leg pain, numbness, tingling, arm pain and numbness, face numbness. 04/14/2021 Severe headache with other symptoms described. ER visit helped severe headache. Fatigue, leg pain, confusion and oversleeping continues. Unable to wake up in the morning, consistently late to work or unable to work. Unmotivated, careless, lack of interest, unable to concentrate or function for normal daily activities. Constant Fog, repetitive headaches. Memory issues and unable to complete familiar job duties and other activities. I feel as if something broke in my brain, I just want to be me again. So far little improvement and symptoms getting worse i am afraid this will be permanent.


VAERS ID: 1260811 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Back pain, Burning sensation, Chills, Fatigue, Headache, Migraine, Pain, Parosmia, Pyrexia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine
Current Illness: None
Preexisting Conditions: Celiac disease
Allergies: Cats, dust mites
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever, chills, shakes, burning sensation, body and backache, headache day of vaccine. Migraine day 2. Muscle pain x 10 days. Fatigue Day of vaccine x7 days. Alteration of smell day of vaccine to current date.


VAERS ID: 1261020 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Chills, Discomfort, Eye irritation, Fatigue, Injection site erythema, Injection site mass, Injection site swelling, Muscle spasms, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: I DID NOT SEEK MEDICAL ATTENTION. I DO NOT HAVE A PRIMARY DOCTOR. I AM TOO NERVOUS TO GO TO THE EMERGENCY ROOM
CDC Split Type:

Write-up: EXTREMELY HEAVY FEELING. COULD NOT GET UP TO EVEN USE THE BATHROOM. FEVER, CHILLS. BURNING EYES. FATIGUE. IT FELT LIKE A REALLY BAD FLU. I STARTED GETTING MUSCEL CRAMPS THE NEXT DAY AND THEY HAVE CONTINUED ON AND OFF SINCE THEN. CRAMPS IN MY STOMACH, LEGS, ARMS AND CHEST. I HAVE ACUTE JOINT PAIN IN MY LEGS AND ARMS. THE INJECTION SIGHT WAS RED, SWOLLEN AND A LUMP FORMED. THE REDNESS AND SWELLING WENT AWAY FINALLY AFTER 2 WEEKS AND TURNED INTO A BRUISE.


VAERS ID: 1261163 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802072 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210422747

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021. the patient got an antibody test which was negative. On 09-APR-2021, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210422747-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine 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.


VAERS ID: 1261209 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chills, Fatigue, Headache, Lymphadenopathy, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210429375

Write-up: SWOLLEN LYMPH NODE; ACHE ALL OVER; ANXIETY; ARM PAIN; CHILLS; TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 35 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced swollen lymph node. On 09-APR-2021, the subject experienced ache all over. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced arm pain. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache all over, and fever on APR-2021, and arm pain, chills, tired, and headache on 10-APR-2021, had not recovered from swollen lymph node, and the outcome of anxiety was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.


VAERS ID: 1261211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN F1808980 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Ophthalmological examination, Optic neuritis
SMQs:, Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions: Comments: Patient had no known drug allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Eye exam; Result Unstructured Data: diagnose with optic neuritis by eye doctor; Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: normal findings; Test Date: 20210413; Test Name: CT scan; Result Unstructured Data: normal findings
CDC Split Type: USJNJFOC20210429417

Write-up: OPTIC NEURITIS; This spontaneous report received from a patient concerned a 53 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non-smoker, and other 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: F1808980, and expiry: UNKNOWN) with unspecified dose on left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, patient experienced loss of vision on the right eye that had not gotten better or worse since then. Patient went to ophthalmologist on 12-APR-2021 who diagnosed patient with optic neuritis and referred to neuro-ophthalmologist. On 13-APR-2021, patient went to emergency eye and ear. Patient was having upcoming appointments with primary doctor and neuro-ophthalmologist at the time of reporting. On 12-APR-2021, Laboratory data included: Dilated pupils (NR: not provided) diagnose with optic neuritis by eye doctor. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) normal findings, and CT scan (NR: not provided) normal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from optic neuritis. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210429417-covid-19 vaccine ad26.cov2.s-Optic neuritis. 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).


VAERS ID: 1261224 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Computerised tomogram head, Headache, Lymphadenopathy, Pyrexia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Computerized tomogram head; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20210430240

Write-up: FEELING OF A LIGHTENING BOLT(ZAP) THROUGH BODY; CHILLS; LOW FEVER; HEADACHE; SWOLLEN GLANDS; This spontaneous report received from a patient concerned a 63 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 was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Computerized tomogram head (NR: not provided) Normal. On 09-APR-2021, the subject experienced swollen glands. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced low fever. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced feeling of a lightening bolt (zap) through body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, low fever, swollen glands, and feeling of a lightening bolt(zap) through body. This report was non-serious.


VAERS ID: 1261234 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430937

Write-up: MUSCLE PAIN; TROUBLE BREATHING; LIGHT-HEADEDNESS/DIZZINESS; 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 of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced trouble breathing. On 09-APR-2021, the subject experienced light-headedness/dizziness. On 14-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headedness/dizziness on 09-APR-2021, and had not recovered from muscle pain, and trouble breathing. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious


VAERS ID: 1261274 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Dysstasia, Hyperhidrosis, Pallor, Presyncope, Pyrexia, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Iodine allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210432841

Write-up: CHILLS; FEVER; LOST MY VISION; CLOSE TO FAINT; PALENESS; DIZZINESS; UNABLE TO STAND; SWEATING; LOSS OF ENERGY IN LEGS/BODY WEAKNESS; This spontaneous report received from a patient concerned a 29 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lost my vision. On 09-APR-2021, the subject experienced close to faint. On 09-APR-2021, the subject experienced paleness. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced unable to stand. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced loss of energy in legs/body weakness. On 10-APR-2021 14:00, the subject experienced chills. On 10-APR-2021 14:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost my vision, close to faint, paleness, dizziness, unable to stand, sweating, and loss of energy in legs/body weakness on 09-APR-2021, and fever on 14-APR-2021, and was recovering from chills. This report was non-serious.; Sender''s Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.


VAERS ID: 1261305 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye disorder, Eye swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DILTIAZEM; LOSARTAN; METFORMIN; ACTONEL; VITAMIN D3; BABY ASPIRIN
Current Illness: Cardiovascular disorder; Drug allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210438187

Write-up: CAPILLARY LEAKAGE; SWELLING OF FACE; SWELLING OF EYES; This spontaneous report received from a consumer concerned a 92 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cardiovascular disease, and polyethylene glycol, polysorbate allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 09:46 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, colecalciferol, diltiazem, losartan, metformin, and risedronate sodium. On 09-APR-2021 18:01, the subject experienced capillary leakage. On 09-APR-2021 18:01, the subject experienced swelling of face. On 09-APR-2021 18:01, the subject experienced swelling of eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of face, capillary leakage and swelling of eyes was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious


VAERS ID: 1261351 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Incorrect dose administered by device
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210443476

Write-up: PARTIAL DOSE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 20 year old of unspecified sex. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced partial dose administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administration was not reported. This report was non-serious.


VAERS ID: 1261390 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary mass, Dysmenorrhoea, Heavy menstrual bleeding, Rash macular, Tinnitus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hearing impairment (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies and did not have any drug abuse or illicit drug usage
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210445319

Write-up: PEA-SIZED GROWTH IN RIGHT AXILLA (ARMPIT AREA); RED SPLOTCHES ON TRUNK (STOMACH AND CHEST) ON FRONT OF BODY; TINNITUS IN RIGHT EAR; RECURRING KNEE ACHES AND JOINT PAIN BEHIND KNEE CAPS (PARTICULARLY RIGHT KNEE); HEAVIER THAN NORMAL MENSTRUAL FLOW; DEBILITATING MENSTRUAL CRAMPS; This spontaneous report received from a patient concerned a 35 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced debilitating menstrual cramps. On 10-APR-2021, the subject experienced heavier than normal menstrual flow. On 14-APR-2021, the subject experienced recurring knee aches and joint pain behind knee caps (particularly right knee). On 15-APR-2021, the subject experienced tinnitus in right ear. On 17-APR-2021, the subject experienced red splotches on trunk (stomach and chest) on front of body. On 18-APR-2021, the subject experienced pea-sized growth in right axilla (armpit area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from debilitating menstrual cramps on 10-APR-2021, and heavier than normal menstrual flow on 11-APR-2021, was recovering from recurring knee aches and joint pain behind knee caps (particularly right knee), and had not recovered from tinnitus in right ear, red splotches on trunk (stomach and chest) on front of body, and pea-sized growth in right axilla (armpit area). This report was non-serious.


VAERS ID: 1261447 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Fatigue, Hypoaesthesia, Investigation, Ophthalmological examination, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Migraine with aura (Numbing, tingling sensations throughout body); Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Blood test; Result Unstructured Data: cleared of blood clots; Test Date: 202104; Test Name: Ophthalmological examination; Result Unstructured Data: clear eyes; Test Date: 202104; Test Name: Screening test; Result Unstructured Data: clear stomach; Test Date: 202104; Test Name: Screening test; Result Unstructured Data: carotids were clear
CDC Split Type: USJNJFOC20210448503

Write-up: NUMBNESS OF EXTREMITIES; TINGLING OF EXTREMITY; MILD SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 71 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included penicillin allergy, and auras with migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) cleared of blood clots, Ophthalmological examination (NR: not provided) clear eyes, and Screening test (NR: not provided) clear stomach, carotids were clear. On 09-APR-2021, the subject experienced mild sore arm. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced numbness of extremities. On 10-APR-2021, the subject experienced tingling of extremity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of extremities, and tingling of extremity on APR-2021, and mild sore arm on 11-APR-2021, and the outcome of tiredness was not reported. This report was non-serious.


VAERS ID: 1261466 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Nevada  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Therapeutic response unexpected
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGNESIUM SULFATE; SPIRONOLACTONE; PREDNISONE; OXYCONTIN
Current Illness: Blood pressure high; Fibromyalgia; Immunocompromised
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic disease (Patient had 41 surgeries for liver disease.); Liver operation (Has had 41 surgeries for liver disease); Comments: The patient had No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210448993

Write-up: PAIN FROM FIBROMYALGIA IS GONE; This spontaneous report received from a patient concerned a 62 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included liver disease, and liver surgery, and concurrent conditions included fibromyalgia, immunocompromised, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included magnesium sulfate for cramping due to liver disease, oxycodone hydrochloride for fibromyalgia, spironolactone for high blood pressure, and prednisone for liver pain, and cramp. On 09-APR-2021, the subject experienced pain from fibromyalgia is gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain from fibromyalgia is gone was not reported. This report was non-serious.


VAERS ID: 1261471 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Illness, Influenza like illness, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19 (Covid-19 test negative.); Feeling sick
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: COVID-19 virus test negative; Result Unstructured Data: Negative; Test Date: 20210424; Test Name: Body temperature; Result Unstructured Data: 100.4 degree F
CDC Split Type: USJNJFOC20210449095

Write-up: FLU-LIKE SYMPTOMS; SICK; FEVER; SORE THROAT; HEADACHE; BODY ACHES; This spontaneous report received from a consumer concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included felt sick, and covid-19. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The batch number was not reported. On APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced sore throat. On 24-APR-2021, the subject experienced flu-like symptoms. On 24-APR-2021, the subject experienced sick. On 24-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, flu-like symptoms, sore throat, and fever, and the outcome of sick was not reported. This report was non serious.


VAERS ID: 1261716 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bell's palsy, Chills, Fatigue, Headache, Lymphadenopathy, Mouth ulceration, Myalgia, Neuralgia, Pyrexia, Vaccination site swelling, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hearing impairment (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POTASSIUM; VITAMIN C [ASCORBIC ACID]; CETIRIZINE; CHLORTHALIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021400060

Write-up: diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.


VAERS ID: 1261723 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN; ATORVASTATIN; PANTOPRAZOLE; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Avascular necrosis; COPD; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021400415

Write-up: I started my period after not having a period since Oct2019.; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration, administered on the right arm at the age of 50 years, on 09Apr2021 08:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma/COPD, stroke, avascular necrosis both hips; all from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (GABAPENTIN); atorvastatin (ATORVASTATIN); pantoprazole (PANTOPRAZOLE) and colecalciferol (VITAMIN D [COLECALCIFEROL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced drug hypersensitivity. The patient stated, "I started my period after not having a period since oct2019" on 09Apr2021 12:15. No treatment was received for the event. The outcome of the event was not recovered.


VAERS ID: 1261740 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 RA / -

Administered by: School       Purchased by: ?
Symptoms: Chills, Dizziness, Dysstasia, Feeling abnormal, Feeling hot, Malaise, Nausea, Pain in extremity, Presyncope, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immune system disorder; Lyme disease; Penicillin allergy (known allergies: Penicillin, morphine); Valley fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021401148

Write-up: This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can''t stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn''t know whether to take the second dose. She felt so sick she couldn''t drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can''t stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.


VAERS ID: 1261748 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cough, Heart rate, Heart rate increased, Hyperpyrexia, Nasopharyngitis, Palpitations
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; LISINOPRIL/HCTZ
Current Illness: Blood pressure high (Diagnosed 3-4 years ago.); Thyroid disorder (States was diagnosed about 23 years ago.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:140; Comments: some high blood pressure problems, sometimes it goes to 140; Test Name: blood pressure; Result Unstructured Data: Test Result:170; Comments: blood pressure went up as high as 170; Test Name: blood pressure; Result Unstructured Data: Test Result:157/68; Comments: her blood pressure is still going up at times 157/68; Test Date: 20210409; Test Name: blood pressure; Result Unstructured Data: Test Result:elevated; Test Name: Fever; Result Unstructured Data: Test Result:107 Fahrenheit; Comments: 107 ?F fever; Test Name: Heart Rate; Result Unstructured Data: Test Result:102; Comments: Her heart rate was also 102.; Test Name: Heart Rate; Result Unstructured Data: Test Result:82; Comments: Her heart rate is 82.; Test Date: 20210409; Test Name: Heart Rate; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC2021401453

Write-up: 107 ?F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; Heart Rate Elevated; Felt palpitations; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 09Apr2021 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Thyroid Condition States was diagnosed about 23 years ago, ongoing High Blood Pressure Diagnosed 3-4 years ago. Concomitant medications included ongoing levothyroxine taken for thyroid condition; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) taken for hypertension. On an unspecified date, the stated she had a 107 ?F fever, "a bit of a cold the same night she got vaccinated, took amoxicillin and is responding good." On 09Apr2021, the blood pressure elevated, cough, Heart Rate Elevated, Felt palpitations. The patient underwent lab tests and procedures which included blood pressure measurement: 140 some high blood pressure problems, sometimes it goes to 140, blood pressure measurement: 170 on an unspecified date blood pressure went up as high as 170, blood pressure measurement: 157/68 on an unspecified date her blood pressure is still going up at times 157/68, body temperature: 107 fahrenheit on an unspecified date 107 ?F fever, heart rate: 102 on unspecified date Her heart rate was also 102 , heart rate: 82 on unspecified date Her heart rate is 82. The outcome was recovering. Relatedness of drug to reaction(s)/event(s): Reaction assessed : Blood Pressure Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result : Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Cough. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Heart Rate Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection; Sender''s Comments: Based on the current available information after FU and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hyperpyrexia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1261778 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Swelling, Thrombosis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021403832

Write-up: Swelling underneath my left arm pit which may be a possible blood clot; Swelling underneath my left arm pit which may be a possible blood clot; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 08Apr2021 (16:15) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 09Apr2021 (05:45), the patient had swelling underneath my left armpit which may be a possible blood clot. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.


VAERS ID: 1261781 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Ohio  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021404101

Write-up: Cardiac arrest; This is a spontaneous report from two contactable consumers. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Lot number was not reported) at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 09Apr2021. The reporter were calling to report that there were 3 students in line behind their daughter waiting to be vaccinated on 09Apr2021. They reported that one of the students in line behind her daughter (patient) went into cardiac arrest following receiving the Covid-19 vaccine. The patient needed to be defibrillated on scene. Treatment was received for the event. The outcome of the event was unknown. Information about Lot/Batch number has been requested.


VAERS ID: 1261787 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Ohio  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021404288

Write-up: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in a clinic facility on 09Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 09Apr2021, the patient experienced convulsions. The outcome of the event was unknown. No follow-up attempts are completed; information about batch/lot cannot be obtained.


VAERS ID: 1261806 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-30
Onset:2021-04-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Laboratory test, Pain, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LISINOPRIL HCTZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Chest CTA scan; Result Unstructured Data: Test Result:Unknown results; Test Name: lab work; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC2021426329

Write-up: blood clot in my lungs/Multiple blood clots; Pains; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer reported for herself that: Patient characteristics: Weight (kg): 102.97 Height (cm): 165 Sex: Female Relevant medical history and concurrent conditions: Structured information (Patient episode name): Hypertension Patient Medical comments: Verbatim: Hypertension Reaction(s)/Event(s): Reaction/event as reported by primary source: Blood clot in my lungs within the first 2 weeks after the second shot Reaction(s)/Event(s): Reaction/event as reported by primary source: Hospitalization Reaction/event in MedDRA terminology (LLT): Hospitalization Reaction/event MedDRA term (PT): Hospitalisation Reaction(s)/Event(s): Reaction/event as reported by primary source: Pains Results of tests and procedures for investigation of the patient: Test: CTA scan More information available (Y/N): No Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Covid-19 Vaccine Batch/lot number: ER8732 Date of start of drug: 30Mar2021 Action(s) taken with drug: Unknown Drug(s) Information: Characterization of drug role: Concomitant Proprietary medicinal product name: Lisinopril HCTZ Dosage text: 20-25 mg Tablet Indication for use in the case: Hypertension Narrative case summary and further information: Case narrative: Selected Report Type: Initial Patient Ethnicity: (Ethnicity withheld) Is the patient also the reporter? Yes Reporter type: Consumer or other non-health professional Reporter telephone: (Phone no withheld) Primary / Prescribing Healthcare Professional Info Dates for Blood clot in my lungs within the first 2 weeks after the second shot.: (From: Unspecified To: Unspecified) Dates for Hospitalization: (From: Unspecified To: Unspecified) Dates for Pains: (From: Unspecified To: Unspecified) Is Covid-19 Vaccine a Pfizer product? Yes Covid-19 Vaccine manufacturer: Unspecified Dates for Covid-19 Vaccine: (Start: 30Mar2021 Stop: Unspecified) NDC number of Covid-19 Vaccine: Unknown UPC number of Covid-19 Vaccine: Unknown Expiry Date of Covid-19 Vaccine: 31Jul2021 Other Products: Yes Dates for Concomitant Products Lisinopril HCTZ: (Start: Unspecified Stop: Unspecified) Patient History: Yes Patient history: Hypertension (From: Unspecified To: Unspecified) Investigation Assessment: Yes Investigation: CTA scan (Date: Unspecified, Result / Units: ) Additional Context: Consumer stated, "I could not follow on the parts. So may be should have done certainly but I am not technically astute. So, I wanted to report that I just had the second Covid-19 test and as a experience in emergency room discovery of blood clot in my lungs within the first 2 weeks after that second shot. So, I wanted to report that. Is this the place I do that?" When paraphrased, consumer stated, "Multiple blood clots." Start date of event (Multiple blood clots.): Consumer stated, "10Apr2021. I should probably say that the pains were 09Apr. I went in the emergency room on the 10th. So, I am not sure which day." Treatment :Consumer stated, "Yes, I went To the emergency room and was kept in the hospital and then I saw my own Doctor just today who is going to help me try to determine what is going to happen next ? I was released by the hospital." Details of hospitalization: Duration of hospitalization: 24 hrs. (overnight) Date of Admission:10Apr2021 Date of Discharge:11Apr2021 Lab work: Consumer stated, "They did lab. work while in the emergency room and in the hospital. They did Chest CTA scan." This is a spontaneous report from a contactable consumer. A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation at age of vaccination 69-year-old. Medical history included hypertension from an unknown date. Concomitant medication included hydrochlorothiazide/lisinopril (LISINOPRIL HCTZ) taken for hypertension, start and stop date were not reported. The patient experienced blood clot in my lungs/multiple blood clots (thrombosis) (hospitalization) on 10Apr2021 with outcome of unknown , pains (pain) (hospitalization) on 09Apr2021 with outcome of unknown. The patient was hospitalized for blood clot in my lungs/multiple blood clots (thrombosis) from 10Apr2021 to 11Apr2021. The patient was hospitalized for pains (pain) from 10Apr2021 to 11Apr2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on , laboratory test: unknown results on . The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of blood clot in my lungs/multiple blood clots (thrombosis), pains (pain).


VAERS ID: 1261929 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Epistaxis, Erythema, Feeling hot, Headache, Myalgia, Pharyngeal swelling, Pyrexia, Rash erythematous, Skin exfoliation, Swelling face, Toothache
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hearing impairment (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: diagnosed with Bells palsy; face was red,Face turning bright red; Like had a worse sunburn on face; face was red hot,extremly hot; Whole face swollen up; Blood out of nose; face pealed,Top of head pealed,face broke out; Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth; Throat swelling; general aches; headache; little bit of fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (diagnosed with Bells palsy) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FACIAL PARALYSIS (diagnosed with Bells palsy) (seriousness criterion medically significant), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), PHARYNGEAL SWELLING (Throat swelling), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever). At the time of the report, FACIAL PARALYSIS (diagnosed with Bells palsy), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever) had not resolved and PHARYNGEAL SWELLING (Throat swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. There is no concomitant list. Treatment includes a steroid shot from doctor after face broke out. Company comment: 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, further information has been requested. Reporter did not allow further contact; 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, further information has been requested.


VAERS ID: 1262404 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Pain, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fatigue, blurred vision, chills, dizziness, bodyache


VAERS ID: 1263011 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Pyrexia, Thrombosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: tylenol, ibu
Current Illness: none
Preexisting Conditions: none
Allergies: PCN, IV Contrast, Macrobid
Diagnostic Lab Data: none. Pt is saying you can see the blood clot
CDC Split Type:

Write-up: Fever over 105, chills, cough, soar throat. aches and pain for 2 days. Led patient to go to the ER on monday 4/12. MD found blood clot at that point. No treatment was given patient was told to follow up with her PCP. Did not go to PCP as yet.


VAERS ID: 1263053 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I reported my reaction but wanted to report that I am still having symptoms. I continue with intermittent nausea and headaches, poor appetite, body aches and joint pain.


VAERS ID: 1263291 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Eliquist, flecinide acitate 500 mg 2x daily, atorzaftatin 40 mg 1x daily, valfartan 160 mg 1x daily, potassium chloride er 8 mg, furofemde 20 mg 1x daily, biotin, d3, iron, vitamin c, b12, methylcobalamin, calcium, gabapentin, ferrousultat
Current Illness:
Preexisting Conditions: high blood pressure, afib
Allergies: penicillin
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Numbness that comes and goes in left hand


VAERS ID: 1263688 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Genital herpes, Herpes simplex, Herpes simplex test negative, Nasal herpes, Oral herpes, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal infections (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: bupropion XL, Gabapentin, duloxitine DR
Current Illness:
Preexisting Conditions: depression and anxiety
Allergies: latex
Diagnostic Lab Data: HSV2 swab test- negative
CDC Split Type:

Write-up: Had the worst cold sore/ herpes outbreak ever. it spread to my genitals, went to doctor and confirmed its still HSV1 and not HSV2. also spread to the inside of my mouth and nose. skin was sloughing off the inside of my nose and the roof of my mouth.


VAERS ID: 1263794 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Headache, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Duloxetine 30mg twice a day, ropinirole .5 mg once a day
Current Illness: None
Preexisting Conditions: Degenerative disc disease
Allergies: Morphine
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe headaches lasting a couple days at a time with a constant headache ever since the shot, severe ringing in the ears nonstop since the shot, severe fatigue since the shot


VAERS ID: 1263952 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Headache, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mirtazapine
Current Illness:
Preexisting Conditions:
Allergies: Amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Body aches, headaches, chest/stomach aches, tiredness. Lasted 2-3 days after the shot.


VAERS ID: 1264162 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / N/A LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi-vitamin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, body aches, fatigue, headache, sore muscles


VAERS ID: 1264403 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Feeling hot, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: EKG; Result Unstructured Data: Unknown
CDC Split Type: USJNJFOC20210437892

Write-up: FEELING HOT; SWEATY; NAUSEA; This spontaneous report received from a patient concerned a 58 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high blood pressure, and severe anaphylactic to penicillin. The patient experienced rash when treated with cefalexin, and headache and vomiting when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feeling hot. On 09-APR-2021, the subject experienced sweaty. On 09-APR-2021, the subject experienced nausea. Laboratory data included: EKG (NR: not provided) Unknown. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, sweaty, and nausea on 11-APR-2021. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1264415 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A22A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dizziness, Dry mouth, Fatigue, Headache, Rash, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy (The patient was allergic to many medications including flu vaccination.)
Preexisting Conditions: Comments: The patient was allergic to many medications including flu vaccination.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210438406

Write-up: BLURRINESS; RASH; DIZZINESS; DRY MOUTH; COUGHING; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient''s height, and weight was not reported. The patient''s concurrent conditions included allergic to many medications including flu vaccination. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A22A expiry: UNKNOWN) dose was not reported, administered 1 total on 09-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that few minutes after administration she started feeling dizzy, dryness in mouth, coughing, felt like there is a cotton ball in mouth, slight rash all over and blurriness. Then she was transferred to the emergency room where they used intravenous (IV) Benadryl and Epipen and they monitored her. Ever since then she still has headaches and tiredness. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), and Epipen (epinephrine) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and tiredness, and the outcome of rash, dizziness, dry mouth, coughing and blurriness was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:-Covid-19 vaccine ad26.cov2.s-Blurring, Coughing, dizziness, dryness of mouth. These events are considered unassessable. The events 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 events. V0:-Covid-19 vaccine ad26.cov2.s-Rash. This events is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1264421 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Influenza like illness, Insomnia
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210440190

Write-up: DIFFICULT TO SLEEP; SHORTNESS OF BREATH; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 60 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and shortness of breath, and the outcome of difficult to sleep was not reported. This report was non-serious.; Sender''s Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.


VAERS ID: 1264453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Endoscopy, Fatigue, Neuro-ophthalmological test, Pyrexia, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]
Current Illness: Alcoholic; Gastrooesophageal reflux disease; Hypochondriacal personality; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Liposuction; Comments: Patient had allergy to all NSAIDS. Patient had No drug abuse or illicit drug usage. Patient consumed One small glass of red wine at night as a preventative for blood clots on the recommendation of a friend who is doctor and the alcohol also thins blood.
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Endoscopy; Result Unstructured Data: unknown; Comments: endoscopy for GERD; Test Date: 20210409; Test Name: Body temperature; Result Unstructured Data: 39.5 C; Test Date: 20210410; Test Name: Body temperature; Result Unstructured Data: 38.5 C; Test Date: 20210421; Test Name: Neuro-ophthalmological test; Result Unstructured Data: Benign vertigo
CDC Split Type: USJNJFOC20210445878

Write-up: BENIGN VERTIGO/ON AND OFF LIGHTHEADEDNESS/FEELING WEIRD; TIREDNESS/FATIGUE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 27 year old male. The patient''s weight was 62 kilograms, and height was 69 inches. The patient''s past medical history included fat removal from chest, and concurrent conditions included gastrooesophageal reflux disease, somewhat of a hypochondriac, penicillin allergy, and alcoholic, and other pre-existing medical conditions included patient had allergy to all NSAIDS (non-steroidal antiinflammatory drugs). patient had no drug abuse or illicit drug usage. patient consumed one small glass of red wine at night as a preventative for blood clots on the recommendation of a friend who is doctor and the alcohol also thins blood. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included pantoprazole sodium sesquihydrate for gerd. On APR-2021, Laboratory data included: Endoscopy (NR: not provided) unknown. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 39.5 C. On 10-APR-2021, the subject experienced tiredness/fatigue. Laboratory data included: Body temperature (NR: not provided) 38.5 C. On 16-APR-2021, the subject experienced benign vertigo/on and off lightheadedness/feeling weird. On 21-APR-2021, Laboratory data included: Neuro-ophthalmological test (NR: not provided) Benign vertigo. Treatment medications (dates unspecified) included: meclozine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-APR-2021, and tiredness/fatigue on 12-APR-2021, and the outcome of benign vertigo/on and off lightheadedness/feeling weird was not reported. This report was non-serious.; Sender''s Comments: MAC- V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1264500 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use (Consumer stated Just socially.); Non-smoker; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Comments: The patient did not have any history of drug abuse or illicit drug use .
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210450493

Write-up: BUMP ON LEFT DELTOID AREA WHERE RECEIVED THE VACCINE; This spontaneous report received from a patient concerned a 42 year old female. The patient''s weight was 270 pounds, and height was 64.8 inches. The patient''s past medical history included anemia, and concurrent conditions included non smoker, alcohol user, and penicillin allergy, and other pre-existing medical conditions included 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced bump on left deltoid area where received the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on left deltoid area where received the vaccine. This report was non-serious.


VAERS ID: 1264509 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Maine  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Dizziness, Fatigue, Headache, Injection site pain, Pain, SARS-CoV-2 test negative, Tenderness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: COVID-19 virus test negative; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210450675

Write-up: SORE FEELS TENDER [BRUISED AREA]; BRUISING ON RIGHT UPPER THIGH TOWARDS THE KNEE CAP/CLUSTERS OF BRUISES; DIZZINESS; HEADACHE (ON AND OFF); ACHING ALL OVER SIMILAR TO AFTER FLU SHOT; TIRED [FOR 3 DAYS POST VACCINE] /EXHAUSTION; SORE INJECTION ARM SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included patient had no known allergies. 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, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 09-APR-2021, the subject experienced aching all over similar to after flu shot. On 09-APR-2021, the subject experienced tired [for 3 days post vaccine] /exhaustion. On 09-APR-2021, the subject experienced sore injection arm site. On 10-APR-2021, the subject experienced headache (on and off). On 24-APR-2021, the subject experienced dizziness. On 25-APR-2021, the subject experienced bruising on right upper thigh towards the knee cap/clusters of bruises. On 25-APR-2021, the subject experienced sore feels tender [bruised area]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching all over similar to after flu shot on 12-APR-2021, and tired [for 3 days post vaccine] /exhaustion, and sore injection arm site on 14-APR-2021, and was recovering from bruising on right upper thigh towards the knee cap/clusters of bruises, dizziness, sore feels tender [bruised area], and headache (on and off). This report was non-serious.


VAERS ID: 1264553 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flonase, ceterizine, prenatal vitamin, iron pill, b12 pill
Current Illness: none
Preexisting Conditions: none
Allergies: Penacillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Menstrual cycle started 2 days after the shot, which was about 5 days early for my usual cycle. Menstrual cycle lasted about 4 or 5 days longer than usual.


VAERS ID: 1264598 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-31
Onset:2021-04-09
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / N/A LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Adverse reaction, Asthenia, Headache, Migraine, Nausea, Pain, Paranasal sinus discomfort, Sinus pain, Vision blurred, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nutrafol Hair Supplement
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 03/09/2021- I started to have mild sinus pain, headache and body ache 03/10/2021- This day my headache turned unbearable like a migraine, the pain shifted in my head, I had preasure around sinus, felt nausea and had body ache.. I took Advil cold and sinus multiple time b/c the pain was so bad. Inhaled menthol rub to try to fine soothes. Used ice to help my throbbing head ache. It lasted all day long. My mom took care of me massaging my head. Had I known know what I know I would have gone to the ER but I didn''t at the time thinking the adverse reaction time for the vaccine had subsided. 03/11/2021- felt much better but weak and my vision seemed a bit off. I had a hard time reading things close to me as it was blurry. Current- I feel fine but my close range vision is blurry


VAERS ID: 1265911 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Fatigue, Pain, Pain in extremity, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MESALAMINE
Current Illness: Colitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: blood work; Result Unstructured Data: Test Result:she was only 3 weeks pregnant; Test Date: 20210411; Test Name: sonogram; Result Unstructured Data: Test Result:no fetal heartbeat
CDC Split Type: USPFIZER INC2021403467

Write-up: miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient''s husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage was unknown while for all other events was not recovered.


VAERS ID: 1265948 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-20
Onset:2021-04-09
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Drug ineffective, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TYLENOL; ZYRTEC DUO; NYQUIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (experiencing her allergies were acting up so she took Tylenol 500mg, 1 pill); Insomnia
Allergies:
Diagnostic Lab Data: Test Name: C scan; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210412; Test Name: Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC2021405823

Write-up: Pulmonary embolism; Shortness of breath; she tested positive for Covid; she tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 52 years of age), dose 1 via an unspecified route of administration on 20Mar2021 12:00 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included allergies wherein she mentioned that her allergies were acting up so she took Tylenol 500mg, 1 pill; and insomnia. Concomitant medications included paracetamol (TYLENOL) taken for hypersensitivity; cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity, start and stop date were not reported; and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for insomnia (it helps her sleep at night), start and stop date were not reported. It was reported that the patient already received 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and was scheduled to receive the 2nd dose on 17Apr2021. Yesterday, she tested positive for Covid and got hospitalized. She said she got discharged today and is now on medication which includes a blood thinner. She wanted to know if she needed to reschedule her 2nd dose, and how. It was clarified that the patient had Covid test on 12Apr2021 with Positive result. She mentioned that she was reading paperwork and it said something about to let her vaccination provider know about medical conditions, allergies, bleeding or if she take blood thinners. She stated that she was prescribed blood thinners yesterday evening and she was going to be taking them for 3-6 months. She questioned if it was going to affect if she takes the shot on Saturday. She added that she will be on the blood thinner 5-6 days by then. She stated that she was tested for Covid in the hospital that she went in with shortness of breath and they did the test yesterday. She had shortness of breath Saturday (09Apr2021) and she went to the ER on 12Apr2021 and was admitted and was released 13Apr2021. She stated that she was diagnosed from being discharged with blood clots and she is now on a blood thinner and a steroid pill for inflammation. She clarified that she was diagnosed on 12Apr2021 with pulmonary embolism and was put on ELIQUIS and will take it for the 1st 7 days, 2 tablets twice a day and they are 5mg each and then she will take 1 tablet twice a day until she follows up with her primary doctor and will either stop taking it at 3 months or 6 months. She will also be taking Dexamethasone 2mg tablet taking 3 tablets once a day for 8 days. She stated that they did a C scan to identify blood clots. There was no other vaccine administered on the same date the Pfizer vaccine was given. The outcome of events was unknown.


VAERS ID: 1266006 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-05
Onset:2021-04-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness, Dyspnoea, Ear pain, Fatigue, Heart rate, Heart rate increased, Nausea, Pain, Pain in extremity, Pharyngeal oedema, Pyrexia, Syncope, Upper-airway cough syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Body temperature; Result Unstructured Data: Test Result:101; Test Date: 20210409; Test Name: Heart rate; Result Unstructured Data: Test Result:118-125 bpm
CDC Split Type: USPFIZER INC2021411433

Write-up: fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; swollen throat; joint pain; fever 101; chills; shortness of breath; elevated heart rate; sinus drainage; entire body pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 05Apr2021 at 09:00 (Batch/Lot Number: ER8734) at 35-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient medical history was not reported. It was unknown if the patient had COVID prior to the vaccination. There were no concomitant medications. On 09Apr2021 (as reported), the patient experienced: fainted (medically significant; also reported as 4 days after vaccine), weak (non-serious; also reported as 1-2 days after vaccine), tired (non-serious; also reported as 1-2 days after vaccine), dizziness, light headed (non-serious; also reported as 4 days after vaccine/ 7 days after vaccine), nausea (non-serious; also reported as 4 days after vaccine), soreness and aches in upper legs (non-serious; also reported as 4-7 days after vaccine), sinus drainage (non-serious; also reported as 4-7 days after vaccine), ear pain (non-serious; also reported as 4-7 days after vaccine), swollen throat (non-serious; also reported as 4-7 days after vaccine), joint pain (non-serious; also reported as 4-7 days after vaccine), fever 101 (non-serious; also reported as 7 days after vaccine), chills (non-serious; also reported as 7 days after vaccine), entire body pain (non-serious; also reported as 7 days after vaccine) shortness of breath (non-serious; also reported as 7 days after vaccine), and elevated heart rate (non-serious; also reported as 7 days after vaccine). The patient underwent lab tests and procedures which included body temperature: 101 on 09Apr2021, heart rate: 118-125 beats per minute (bpm) on 09Apr2021. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.


VAERS ID: 1266013 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: School       Purchased by: ?
Symptoms: Loss of consciousness, Pain, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021412523

Write-up: I have passed out three times.; arm pain; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The facility type vaccine was school or student health clinic. There were no other vaccine in four weeks. On 09Apr2021 at 14:45, the patient have passed out three times. The patient also had arm pain and body aches on 09Apr2021 14:45. She had no fever, and she was well hydrated. She have not taken any medication at all since then. There was no treatment for the events. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.


VAERS ID: 1266243 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Hypoaesthesia oral, Oxygen saturation, Oxygen saturation decreased, Palpitations, Paraesthesia oral
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA
Current Illness: Blood pressure fluctuation (normal to low on MAR-2021, the patient''s blood pressure was 110-115); Seasonal allergy (Patient take antihistamine (Allegra) for it)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: 110-115 normal value 75-80; Test Date: 202104; Test Name: Heart rate; Result Unstructured Data: HIGH; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 120-135; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 145-165; Test Date: 202104; Test Name: Heart rate; Result Unstructured Data: 0ver 115; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: consistently not dropped below 145 systolic; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 145-165; Test Date: 20210409; Test Name: Pulse oximetry; Result Unstructured Data: oxygen level 91 normal value 95-97; Test Date: 20210409; Test Name: Heart rate; Result Unstructured Data: resting heart rate 115 normal value 75-80; Test Date: 20210410; Test Name: Blood pressure; Result Unstructured Data: 135; Test Date: 20210410; Test Name: Heart rate; Result Unstructured Data: 95; Test Date: 20210410; Test Name: Blood pressure; Result Unstructured Data: 145 systolic range
CDC Split Type: USJNJFOC20210421070

Write-up: HEART STARTED RACING; LIPS FELT NUMB; LIGHT HEADED; LIPS FELT TINGLY; BLOOD PRESSURE INCREASED TO 145-165/120-135; OXYGEN SATURATION DECREASED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient''s past medical history included appendix surgery, and concurrent conditions included blood pressure fluctuation (on MAR-2021, the patient''s blood pressure (BP) was 110-115), and seasonal allergies. 09-APR-2021, patient took an antihistamine (Allegra) for seasonal allergies before vaccine shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 09-APR-2021 at 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fexofenadine hydrochloride for seasonal allergies. On 09-APR-2021, within the first 15 minutes of vaccination, the patient felt numb and tingly lips and was light headed. The patient waited another 30 minutes at the vaccine center just to be sure symptoms should not progress further. The patient was light headed all day. On same day around 21:00, while laying in bed, patients heart started racing. As patient had pulse oximeter at home so used and resting heart rate was 115 and oxygen level 91. It was reported that patients normal heart rate and oxygen usually remains 75-80 and 95-97 respectively. Patients'' blood pressure (BP) had been normal to low all of life, so the sudden spike was completely uncharacteristic. Then Patient called an ambulance at that time patients BP was 145-165/120-135. On 10-APR-2021, initially patient declined to go to hospital, but as patients heart rate was so bad then went to emergency room (ER). The patient waited from 12-4 a.m, but hospital was overrun so not got admitted. So checked BP every hour and it was consistently not drop below 145 systolic and heart rate was over 115. Then patient went to home. On 10-APR-2021, all day, patients heart rate was high, so patient bought a BP cuff to test BP, and it was still 145 systolic range. On 10-APR-2021 at night the patients BP and heart rate started to come down to 135/95. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart started racing, and blood pressure increased to 145-165/120-135, and the outcome of lips felt numb, light headed, lips felt tingly and oxygen saturation decreased was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 :-covid-19 vaccine ad26.cov2.s -blood pressure increased to 145 -165/120-135. 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, UNDERLYING DISEASE.


VAERS ID: 1267023 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Headache, Hypersensitivity, Hypoaesthesia oral, Paraesthesia oral, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Got J&J vaccine at our clinic on 4/9/21. Notes that several hours later he developed HA and hives over his abdomen. Sx got worse overnight, and by the next morning he noticed additional sx of tongue numbness/tingling, so went to the ER. ER diagnosed him with allergic reaction and discharged him with a short course of steroids and Rx for Banophen. He notes that the symptoms returned again on 4/24/21, and again this morning 4/28/21. Went back to ER on 4/24, got more steroids and sx went away. This morning bought OTC Benadryl and sx went away when he took 50-100mg.


VAERS ID: 1267609 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / N/A LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unable to answer.
Current Illness: Unable to answer.
Preexisting Conditions: Unable to answer.
Allergies: Patient stated none.
Diagnostic Lab Data: Patient was taken to PCP. We were unable to get in contact with him about tests post vaccination.
CDC Split Type:

Write-up: Patient came to vaccination site for the Janssen Covid-19 vaccine on April 09, 2021. After receiving the vaccine, given by a Medical Assistant, he stated that he was ?not feeling himself and was lightheaded?. Medical Assistant, told him to put his car seat back and that she was going to get the automatic BP cuff to take his BP. Medical assistant also let two RNs, know about the incident and they also observed the patient when he was getting his BP taken by Medical Assistant at 9:10am. The first BP was taken on the left arm and was 199/119 and pulse was 72. The second was taken immediately after on the right arm by a RN and was 191/116 and pulse was 78. At 9:22am, RN called our Pharmacist and explained the symptoms the patient was having. She advised the nurses to call EMS. The RNs then took BP again at 9:23 am on the left arm, this time it was 199/116 and pulse was 72. The RNs explained to the patient they were going to have to call EMS to take him to the hospital due to his hypertension. Patient refused EMS transport and stated he would go to his doctor, but that he wants a manual BP taken. The RNs stated he would need to call someone to pick him up to transport him to his doctor. Patient called wife to pick him up. RN stated at 9:27am that a staff member was going to get the manual BP cuff. At 9:35am second RN checked patient and he stated he ?felt fine?. At 9:45am, second RN checked patient again, and he stated he was ?feeling better?. At 9:55am, second RN checked BP with the manual BP cuff on the left arm and it was 215/118 and pulse 75. At 10:00 am second RN gave patient a bottle of water, because he stated he was thirsty. Second RN asked to check BP again at 10:01am on the left arm, manually and it was 194/115 and pulse was 81. Second RN took manual BP again at 10:06 am and it was 190/110 and pulse was 82. Crackers were also given to patient at this time. At 10:18am wife picked up patient and took him to his MD office at 10:18. On April 10th, 2021, at 10:27am, RN reached out to patient via phone but patient did not pick up or call back.


VAERS ID: 1268279 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Cellulitis orbital, Chills, Computerised tomogram, Drug trough level, Erythema, Eye pain, Eye swelling, Fibrin D dimer, Full blood count, Headache, Heart rate increased, Laboratory test, Metabolic function test, Periorbital cellulitis, Pyrexia, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CBC, PTT, CMP, D-Dimer, Vanco Trough, CT-Scan April 13- April 17, 2021
CDC Split Type:

Write-up: Red patchy face, felt like a sunburn later severe headache, chills, fever, rapid heartbeat, stopped14 hours later, slight headache 72 hours later left eye pain, 84 hours later left eye swelling, went to PCP. Put on antibiotics and eye drops returned to PCP no improvement. The swelling got worse on Thursday, April 15 was admitted to hospital for orbital cellulitis. Lab tests, CT scan and recieved iv antibiotics and steroids. Discharged diagnosed as periorbital cellulitis on Saturday April 17 was put on oral antibiotics and eyedrops.


VAERS ID: 1268919 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Breast pain, Breast tenderness, Chest pain, Dizziness, Fatigue, Headache, Nausea, Pain, Pain in extremity, Pyrexia, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nortriptyline, magnesium, paxil, gabapentin, riboflavin, d3, b12, zinc, flaxseed oil
Current Illness: None
Preexisting Conditions: Asthma, fibromyalgia, atrial septal defect, mitral valve prolapse, epstein barr flare ups, migraine
Allergies: Penicillin, ampicillin, erythromycin, sulfa, cefaclor, ceclor, macrodantin, nitrofurantoin, morphine
Diagnostic Lab Data: Ultrasound performed on April 16 showed no presence of blood clots.
CDC Split Type:

Write-up: Fever lasted two days, severe headache lasted two days, body aches lasted over a week, nausea is still present, fatigue is still present, arm soreness lasted a little over a week, dizziness is still present. Stabbing pains in my hands, feet and legs started a few days after the vaccine and my rheumatologist ordered ultrasounds on my legs, which showed no presence of clots. The pains lasted for about 12 days. Pain in my chest and breasts occurred yesterday and lasted about 2 minutes. Nipples are tender.


VAERS ID: 1269150 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood glucose abnormal, Cataract, Dizziness, Dysuria, Eczema, Headache, Penile oedema
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes (Does not take any medication, only checking blood sugar once a day.)
Preexisting Conditions: Comments: Patient take 7 up to alleviate symptoms. Patient assaulted by getting cut in neck and need blood transfusion.
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: Blood sugar abnormal; Result Unstructured Data: 319
CDC Split Type: USJNJFOC20210448488

Write-up: LEFT EYE TRAUMA/ CATARACT; RASH ALL OVER BODY ARM/ECZEMA; SHOULDER PAIN/SORENES/WOUND; BLOOD SUGAR ABNORMAL 319; URINATION PROBLEM; MALE GLAND (REALLY BIG) WAS SWOLLEN/ RED; FEELING OF PASSING; LIGHT HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 57 years old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included diabetes (did not take any medication). Patient was assaulted before getting the Covid-19 vaccine and was cut in the neck and needed blood transfusion last OCT-2020. Patient got several vaccinations. Last vaccination he received was in 1980. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, 1 day after vaccination, patient experienced light headache, feeling of passing and weakness. On 11-APR-2021, after 2-3 days of vaccination, patient was suffering from urination problem which included swollen male gland/ redness (peeling of the skin /flesh is visible /getting worse) and pain during urination. He had pain upon pulling back his foreskin (he was not circumcised and never had such problems). On unspecified day, he had trouble in vision. He visited two doctors regarding the problem who stated that patient had left eye trauma (cataract). On unspecified date. he also had rashes all over the body (specifically arms) referred as eczema. On an unspecified date, he had shoulder pain/soreness/wound on both shoulders right as well left. Skin of the left shoulder was peeled and flesh was visible. He stated that peeling of the skin was moving towards the back of his shoulder and was getting worse. He had tattoos on his left and right shoulder/arm. As per patient, he was given a lot of shots in his right during his profession. Patient has abnormal blood sugar level. On 23-APR-2021, Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 319. Treatment medications (dates unspecified) included: bismuth subsalicylate and took 7 up to alleviate symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye trauma/ cataract, urination problem, rash all over body arm/eczema, weakness, feeling of passing, light headache, and male gland (really big) was swollen/ red, and the outcome of shoulder pain/sorenes/wound and blood sugar abnormal 319 was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 : 20210448488 - COVID-19 VACCINE AD26.COV2.S - left eye trauma / cataract . 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). 20210448488-COVID-19 VACCINE AD26.COV2.S-BLOOD SUGAR ABNORMAL 319 .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, UNDERLYING DISEASE


VAERS ID: 1269155 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Limb mass
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210450026

Write-up: LUMP INSIDE MUSCLE OF LEFT SHOULDER WHICH IS TENDER TO THE TOUCH ON A SCALE OF 1 TO 10; This spontaneous report received from a patient concerned a 69 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lump inside muscle of left shoulder which is tender to the touch on a scale of 1 to 10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lump inside muscle of left shoulder which is tender to the touch on a scale of 1 to 10. This report was non-serious.


VAERS ID: 1269174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-erythropoietin antibody negative, Antibody test
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphatic leukemia; Drug abuse; Frequency urinary; Comments: The patient had no known drug allergies, non-smoker and non-alcoholic. The patient used Marijuana for drug abuse.
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Antibody test; Result Unstructured Data: NEGATIVE
CDC Split Type: USJNJFOC20210452490

Write-up: NEGATIVE ANTIBODY TEST; This spontaneous report received from a patient concerned a 71 year old male. The patient''s weight was 125 pounds, and height was 170 centimeters. The patient''s past medical history included chronic lymphatic leukemia, frequent urination, and drug abuse, and other pre-existing medical conditions included the patient had no known drug allergies, non-smoker and non-alcoholic. the patient used marijuana for drug abuse. The patient was previously treated with lithium, and cannabis sativa for drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced negative antibody test. Laboratory data included: Antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from negative antibody test. This report was non-serious.


VAERS ID: 1269496 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Gastrointestinal disorder, Pharyngeal swelling, Productive cough, Therapeutic response unexpected, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EPINEPHRINE
Current Illness: Alcohol use (Not very often.); Allergic asthma (Carries EPI pen); Allergic reaction to antibiotics (hives); Allergy to molds; Constipation; Drug allergy (hives); Exhaustion; Foggy feeling in head; Irritable bowel; Joint pain; Malaise; Memory disturbance; Migraine; Non-smoker; Osteoarthritis; Penicillin allergy (whole body rash); Pollen allergy; Raynaud''s syndrome; Sleep disturbance; Sulfonamide allergy (hands and feet hives)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Unconfirmed by test); Comments: The patient was not pregnant at the time of reporting. The patient had no history of drug abuse or illicit drug usage. The patient increased the use of normal nebulizer from sporadically to daily for months that caused a trip to the emergency room in Apr-2020.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210454156

Write-up: EXPELLED PEA SIZED MUCUS BOLUS WITH BLACK CENTER WHEN COUGHING OR BLOWING NOSE; UNEXPECTED THERAPEUTIC BENEFIT; TIRED; GASTROINTESTINAL TRACT PAINFUL; BLURRED VISION; THROAT SWELLING REQUIRING MOUTH BREATHING; This spontaneous report received from a patient concerned a 73 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included covid 19/covid cough, and concurrent conditions included migranes, osteoarthritis, irritable bowel, constipation, reactive asthma, malaise, exhaustion, brain fog, migrating joint pain, disturbed sleep pattern, mold allergy, pollen grass allergy, raynaud''s syndrome, alcohol use, memory disturbances, non smoker, sulfonamide allergy, tetracycline allergy, barbiturate allergy, and penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient increased the use of normal nebulizer from sporadically to daily for months that caused a trip to the emergency room in apr-2020. The patient was previously treated with butalbital/caffeine/paracetamol; and experienced cut off vital organs to brain shut down blood vessels when treated with cimetidine for migraine, and low blood pressure when treated with pethidine hydrochloride, tachycardia when treated with oxycodone hydrochloride/paracetamol, and throat swelling when treated with capsaicin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine. On 09-APR-2021, the subject experienced blurred vision. On 09-APR-2021, the subject experienced throat swelling requiring mouth breathing. On 10-APR-2021, the subject experienced gastrointestinal tract painful. On 11-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced unexpected therapeutic benefit. On 20-APR-2021, the subject experienced expelled pea sized mucus bolus with black center when coughing or blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and throat swelling requiring mouth breathing on 09-APR-2021, and tired on 12-APR-2021, was recovering from unexpected therapeutic benefit, had not recovered from gastrointestinal tract painful, and the outcome of expelled pea sized mucus bolus with black center when coughing or blowing nose was not reported. This report was non-serious.


VAERS ID: 1269507 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO153 / 2 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Nerve injury, Neurological symptom
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Scoliosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021405996

Write-up: His brain just felt like he lost nerves; weird neurological effect; makes him almost feel light headed / Like the top of his head feels more "light"/he do get lightheaded; top of his head feels really empty; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 07Apr2021 18:15 (Batch/Lot Number: EWO153) as single dose for covid-19 immunisation. Medical history included scoliosis. Patient previously received the first dose of BNT162B2 (lot number: ENG205), on 17Mar2021,17:30, in the left arm, fore COVID-19 immunization and experienced some lower back pain and mild chills. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 09Apr2021 15:00, the patient experienced that the top of his head feels really empty. He was not light headed per se. Well, maybe the top of his head feels a bit lightheaded. His brain just felt like he lost nerves and it makes him almost feel light headed when he try to lie down and fall asleep. Like the top of his head feels more "light". He was not sure if this was some weird neurological effect. Also sometimes if he just stay still and space out on purpose, he do get lightheaded. The outcome of events was reported as "not recovered". Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.


VAERS ID: 1269555 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-03
Onset:2021-04-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 2 LA / OT

Administered by: Military       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, venous (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CRESTOR; LISINOPRIL; METFORMIN; OMEPRAZOLE
Current Illness: Blood pressure high (Diagnosed about 5 years ago); Diabetes (Diagnosed about 5 years ago); GERD; Hypercholesteremia
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker (She has been smoke-free for 15 years.)
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: CAT scan; Result Unstructured Data: Test Result:Pulmonary Embolism; Test Date: 20210409; Test Name: Covid-19 Test; Test Result: Positive
CDC Split Type: USPFIZER INC2021413231

Write-up: Pulmonary embolism; tested positive for Covid/shortness of breath/severe cough/headache; tested positive for Covid/shortness of breath/severe cough/headache; This is a spontaneous report from a contactable nurse (patient). The nurse reported similar events for herself and her daughter. This is the first of two cases. A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the first dose administered in the right arm on 14Mar2021 (Batch/Lot Number: EN6208) and the second dose administered in the left arm on 03Apr2021 at 10:45 (Batch/Lot Number: ER8737), both intramuscular as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure both diagnosed 5 years ago, GERD and hypercholesteremia, all ongoing. The patient was a former smoker but has been smoke-free for 15 years. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for hypercholesterolaemia from an unspecified start date and ongoing; lisinopril (manufacturer unknown) taken for high blood pressure from an unspecified start date and ongoing; metformin (manufacturer unknown) taken for diabetes from an unspecified start date and ongoing and omeprazole (manufacturer unknown) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. The patient did not have any prior vaccinations within 4 weeks of the COVID vaccine. The patient reported that she and her daughter had their second dose of the vaccine on 03Apr2021. The patient tested positive for Covid. The patient developed shortness of breath on Sunday, 11Apr2021, and ended up with a pulmonary embolism. The patient doesn''t know if she was possibly infected before they got the second vaccine and were asymptomatic and unknown or did they get infected when got they got the vaccine with thousands of other people. At the time of the report, the patient was mostly resolved and they are all home. She became short of breath, had severe cough and headache and she went to the ER and on the CAT scan they discovered she had a small pulmonary emboli. She was hospitalized from 11Apr2021-12Apr2021. The patient was given Eliquis and monoclonal antibodies as treatment for the events. The patient stated that she will be on Eliquis for the next month because of the pulmonary embolism. The patient did not need any additional therapies for COVID-19. The patient did not have any pre-existing diseases that worsened during the SARS-CoV2 infection. The outcome of the event ''tested positive for Covid/shortness of breath/severe cough/headache'' was not recovered while the outcome of the event pulmonary embolism was recovering. The relatedness of the suspect drug to the reactions was unknown.; Sender''s Comments: Based on the information provided by the reporter, it appears reasonable that the suspect drug did not contribute to the development of the reported event pulmonary embolism, that most likely was related to the concurrent development of COVID-19. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021413236 same reporter and drug, similat event, different patient


VAERS ID: 1269759 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Fall, Hip fracture, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Bypass surgery; Diabetes
Allergies:
Diagnostic Lab Data: Test Name: fever; Result Unstructured Data: Test Result:102.8
CDC Split Type: USPFIZER INC2021437171

Write-up: Weakness in his legs; went up falling and breaking his hip; went up falling and breaking his hip; fell ill as he had fever close to 102.8 fever; This is a spontaneous report from a contactable consumer (reporting for father). A 75-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm on 08Apr2021 (Batch/Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunization. Medical history included hypertension, diabetes mellitus and leg bypass surgery. The patient took many medications (unspecified). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on unknown date ( Batch/Lot Number not provided) as COVID-19 immunization. The reporter just recently found out that the patient got the 2nd dose of vaccine on 08Apr2021. On unspecified date, he fell ill as he had fever close to 102.8 fever. The patient also has weakness in his legs and he went up falling and breaking his hip/ fractured his hip. The patient was admitted on the hospital on that same unspecified day and was being treated for his hip which require the partial hip replacement surgery. Outcome of the events were unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1269930 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Oklahoma  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Blood glucose abnormal, COVID-19, Diarrhoea, Dizziness, Hysterectomy, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ASPRIN; LISINOPRIL; TRULICITY; VITAMIN D [ERGOCALCIFEROL]; HYDROCHLOROTHIAZIDE; METFORMIN; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THI
Current Illness: Alcohol use (once in year); Diabetes; Hypertension (since age 19); Nonsmoker; Seasonal allergy
Preexisting Conditions: Comments: The patient had no history of drug abuse/illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Date: 20210410; Test Name: Blood sugar abnormal; Result Unstructured Data: not reported; Test Date: 20210413; Test Name: COVID-19 virus test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20210428837

Write-up: CONFIRMED COVID 19; DIZZINESS; VOMITING; LOSS OF TASTE; LOSS OF SMELL; DIARRHEA; FEVER; HYSTERECTOMY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient''s concurrent conditions included diabetes, hypertension, alcohol use, seasonal allergy, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, amlodipine for hypertension, acetylsalicylic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, dulaglutide, ergocalciferol, hydrochlorothiazide, and lisinopril. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 09-APR-2021, the subject experienced hysterectomy. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced loss of taste. On 10-APR-2021, the subject experienced loss of smell. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced fever. Laboratory data included: Blood sugar abnormal (NR: not provided) not reported. On 13-APR-2021, the subject experienced confirmed covid 19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, had not recovered from dizziness, loss of taste, loss of smell, fever, and diarrhea, and the outcome of confirmed covid 19 and hysterectomy was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.


VAERS ID: 1269965 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210450662

Write-up: HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 57 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, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced pain at injection site. On 11-APR-2021, the subject experienced headache. On 26-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 12-APR-2021, and had not recovered from headache. This report was non-serious.


VAERS ID: 1269969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acid base balance, Fatigue, Full blood count, Headache, Platelet count, Pyrexia, Rash erythematous, Red blood cell count
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety; Sinus infection
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: CBC; Result Unstructured Data: Fine; Test Date: 20210420; Test Name: Platelet count; Result Unstructured Data: Fine; Test Date: 20210420; Test Name: Red blood cell count; Result Unstructured Data: Fine; Test Date: 20210420; Test Name: Acid base balance; Result Unstructured Data: Fine
CDC Split Type: USJNJFOC20210451343

Write-up: RED SPOTS; LITTLE TIRED; SLIGHT HEADACHE; LOW GRADE TEMPERATURE; This spontaneous report received from a patient concerned a 54 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included severe anxiety, and sinus infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced little tired, slight headache. On 09-APR-2021 and low grade temperature. On 20-APR-2021, the subject experienced red spots. Laboratory data included: Acid base balance (NR: not provided) Fine, CBC (NR: not provided) Fine, Platelet count (NR: not provided) Fine, and Red blood cell count (NR: not provided) Fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little tired, slight headache, and low grade temperature on 11-APR-2021, and the outcome of red spots was not reported. This report was non-serious.


VAERS ID: 1270011 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Unknown  
Location: New Mexico  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026B21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, Euphoric mood, Feeling abnormal, Hallucination, Headache, Myalgia, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL; DROXIDOPA; SINGULAIR; GABAPENTIN; CLONAZEPAM AUDEN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: feel weird, objects looked distorted,; could not sleep; felt hyperactive with her eyes popping out of her head; bone pain; muscle soreness; Headache; hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included GABAPENTIN for Peripheral neuropathy, CLONAZEPAM (CLONAZEPAM AUDEN) for Seizures, METOPROLOL, DROXIDOPA and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain) and MYALGIA (muscle soreness). On 11-Apr-2021, HALLUCINATION (hallucinations) had resolved. At the time of the report, FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain), MYALGIA (muscle soreness) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment given included Naproxen. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache and myalgia are consistent with the product safety profile.; Sender''s Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache and myalgia are consistent with the product safety profile.


VAERS ID: 1271324 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Head titubation, Loss of personal independence in daily activities, Sleep disorder, Tinnitus
SMQs:, Dementia (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu vaccine, 3 years ago. She felt like she was going to pass out for about 3 months, really dizzy all the time and almost pass
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: Penicillin, Flagyl, Codeine.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: She received her vaccine, and on 4/9/21 she developed a severe ringing in her right ear really loud. It then just kept getting worse and worse and then went to the other ear. Then there was a buzzing at night inside her head. She started getting head tremors inside of her head, and it has not stopped as of 4/29/21. She called her doctor and talked to him and he gave her Zyrtec, however, she is very very sensitive to medications so she could not take a lot of it. It didn''t help the right ear which is the worst one. The left ear just started to subside a little bit. It has now been on and off, but still pretty severe in the right ear. The head tremors feel like shaking inside of her head which are not apparent from the outside, and the buzzing. She had another phone APT again and she is scheduled to see a specialist an ENT on 5/3/21 as the condition is debilitating. She is not able to sleep, eat or function due to this condition.


VAERS ID: 1271345 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Blood count, Blood triglycerides increased, Chills, Decreased appetite, Fibrin D dimer, Headache, Immediate post-injection reaction, Insomnia, Myalgia, Nausea, Neck pain, Pain in extremity, Pyrexia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: asthma
Allergies: none
Diagnostic Lab Data: Went to urgent care and received tests for ddimer and blood count. The urgent care''s lab was unable to get results and advised me to go the the emergency room. The emergency room tested my blood and found that my triglyceride level was high. I never had a high triglyceride level before.
CDC Split Type:

Write-up: Within about 5 seconds of receiving the vaccination my arm felt extremely sore; approximately 30 minutes later it felt like the neck swelled up and I developed a headache; the next morning I had a severe headache, nausea, fever, chills, pain in my neck, and severe muscle aches that lasted for approximately 2 days; during that time I could not sleep or eat; my stomach felt off for about 10 days; the headache improved but lasted approximately 2 weeks; the swelling in my neck seems to have improved but has not gone away completely


VAERS ID: 1271349 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-01
Onset:2021-04-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pruritic, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NO
Preexisting Conditions: RHEUMATOID ARTHRITIS
Allergies: NO
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: NINE DAYS AFTER patient RECEIVED THE VACCINE SHE DEVELOPED A RASH ON HER SHOULDERS. RASH SPREAD TO 50% OF HER BACK, RASH CONTINUED DOWN HER ARMS. NO LYMPH NODE INVOLVEMENT. RASH WAS RAISED, RED, VERY ITCHY, WARM TO TOUCH. RASH IS STILL PRESENT AND NEW AREA DEVELOPING ON BACK OF UPPER LEFT LEG. patient NOTED SEVERAL DAYS BEFORE RASH APPEARED SHOULDERS WERE VERY ITCHY.


VAERS ID: 1271592 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature increased, Chills, Hyperhidrosis, Myalgia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 10 mg amlodipine; 25 mg hydroclorithyozide
Current Illness: None known
Preexisting Conditions: High blood pressure; sun clinical hypothyroidism
Allergies: None known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe muscle and joint pain lasting about 36 hours. 7-7-8/10 on pain scale. Fever of 102.3 lasting for about 8-10 hours. Fever broke early morning Saturday. Sweats and severe chills that caused entire body to shake lasting about 6-8 hours Friday night. No OTC meds helped. Tried Advil and Tylenol. Stayed in bed and waited it out. Decided not to call doctor after reading info booklet on vax saying it was ?normal ? reaction to have pain, fever, sweats and chills. All symptoms were subsided by Sunday evening.


VAERS ID: 1272077 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Bone pain, Headache, Laboratory test, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: lab work performed
CDC Split Type: vsafe

Write-up: I started with fever, vomiting, bodily pain, bone/joint pain and head pain the early morning after my J&J vaccine which these symptoms lasted two days. There after I started to experience severe, constant headaches that come and go. My headaches are worse when bending down. I went to hospital and they performed lab work and told me it was a reaction to the vaccine. To this day my headaches come and go every day.


VAERS ID: 1272096 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / N/A LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Chest pain, Chills, Dizziness, Immediate post-injection reaction, Musculoskeletal stiffness, Pain, Periarthritis, Pyrexia, Vestibular migraine
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Vitamin D3 Co-Q 10 Magnesium Citrate D-Ribos Powder Claritin PRN Zinc
Current Illness:
Preexisting Conditions: Fibromyalgia Vestibular Migraines
Allergies:
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: Ten hours after I got the shot I got violent chills and fever(100.4), muscle aches all over. My quad muscles are still a little achy and weak. It lasted 36 hours and then I felt my Vestibular Migraines. I was dizzier than usual. Under my left armpit was very painful reaching toward my left breast. The area of the shot was not painful. I also had dizziness chest pains under my right clavicle immediately after I got the shot. The chest pain went away for three days and then it came back. It was like an extreme muscle ache. It was a dull and intermittent pain. I was referred to a Respiratory clinic and I still had a low grade fever. My left arm was stiff two weeks before the shot and three days after the shot my left shoulder was frozen. I had an appointment with my Orthopedist and she confirmed an encapsulated shoulder problem. At present after three weeks my shoulder is still frozen and my armpit is still a little painful. The chest pains are less frequent.


VAERS ID: 1178980 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Back pain, Balance disorder, Headache, Hypersensitivity, Mental impairment, Myalgia, Nausea, Pyrexia, Skin warm, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: N/A
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: ROS: General: + fever, no chills HEENT: no Eye redness, + visual disturbance; no Ear pain, no rhinorrhea, no Mouth lesions, no sore throat; no Facial pain; no Neck pain Pulmonary: n Additional information for Item 19: ROS: General: + fever, no chills HEENT: no Eye redness, + visual disturbance; no Ear pain, no rhinorrhea, no Mouth lesions, no sore throat; no Facial pain; no Neck pain Pulmonary: no shortness of breath, no cough, no chest wall lesions Cardiovascular: no chest pain, no extremity coolness, no cyanosis, no new edema Abdomen: no abdominal pain, + nausea, no vomiting, no diarrhea GU: no dysuria, no hematuria Musculoskeletal: no limited ROM; +muscle ache; +low back pain Neuro: + headache, no new numbness/tingling, no new weakness, no speech disturbance, + balance issue Skin: no new rash All systems were reviewed and negative except as noted above Physical exam: General: Patient appears to be in mild-mod distress HEENT: normal conjunctivae and PERRL; no rhinorrhea; no mouth lesions; no facial swelling; normal voice; no overt photophobia; no Horner and no nystagmus; reports decreased but not absent peripheral vision, symmetric, in bilateral eyes. Neck: no overt swelling. Neck supple. Pulmonary: normal work of breathing; Abdomen: abdomen soft, non-tender, without guarding. No abnormal distention Extremities: no edema; normal ROMs of extremities Skin: warm extremities Neuro: alert, with normal attention. Face symmetrical. Normal motor movements of extremities. No paresthesia. Normal speech and no evidence of truncal ataxia Psych: normal mood Assessment and Plan: I suspect symptoms are due to COVID-19 vaccine rather than pituitary apoplexy or intracranial mass. Will do meds and re-assess.
CDC Split Type:

Write-up: allergic reaction. Patient reports blurry eyesight, headache, fever, feels like he cant think clearly, patient reports balance has been off, and back pain x 6 hours. Received J&J vaccine at 1800 last night. Denies vomiting and diarrhea.History: pt had J&J COVID-19 vaccine yesterday evening and here with headache, lack of balance (but able to walk), blurry vision with loss of peripheral vision, fever, back pain, some nausea, here for eval. Says he was in his usual state of health before vaccination and no recent sick contact or COVID-19 hotspot visit. No prior co-morbidities and denies recent illness/injury, use of any meds.


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