chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SITE SWELLING; THROMBOSIS IN LEFT ARM; This spontaneous report received from a patient concerned a 63 year old female of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 16-AUG-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. Age at time of vaccination 63 years old. No concomitant medications were reported.  On APR-2021, the patient experienced thrombosis (Blood clot) in left arm. On JUN-2022, the patient experienced injection site swelling. The latency between covid-19 vaccine and swelling was reported as 14 months. On an unspecified date in 2021, the patient experienced pain from blood clot in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, and action taken with adalimumab was not reported. The patient recovered from injection site swelling on JUN-2022, and the outcome of thrombosis in left arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220826101-covid-19 vaccine ad26.cov2.s- Thrombosis in left arm. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.
Information has been received from a physician concerning an 18 year old female who was vaccinated with the third dose of GARDASIL vaccine(dose, route and lot# not reported). The patient might have developed vasculitis after receiving the first dose of GARDASIL vaccine. After the third dose of GARDASIL vaccine, a pulmonologist diagnosed that the patient with vasculitis of the lungs. The patient sought medical attention  for her adverse experience and then the patient recovered from the vasculitis of the lungs. The pulmonologist attributed the vasculitis to GARDASIL vaccine. Additional information has been requested.  1/27/2009  MR received from vascular, pulmonary and sleep clinics. Pt seen 3/3/2008 in Vascular clinic for abnormal chest CT which showed an subclavian vein stenosis with collaterals seen to supply R arm.  CT done to r/o PE due to SOB. No dx noted. Seen in pulmonary clinic 3/31/2008 for eval of hypoxia. In Jan 2008 pt developed cough with blood tinged sputum. DX with Bronchitis with low O2 sats, now improved, however cough remains with occasional choking episodes. Also recently dx with Livido Reticularis due to lacy mottling and coolness of the distal extremities. Reports subQ nodules after HPV shots. PE (+) for lacy reticular rash in arms and legs. Deep coughing spells noted by parent.  No interstitial lung disease and unlikely pulmonary HTN. Referred to sleep clinic. Seen in sleep clinic for choking/coughing episodes at night. On altered school schedule due to sleep disturbances.  Purple discoloration of legs noted on PE.  1/23/09  07-JAN-2009, Dr provided to CDC most of the requested information and the following additional details:  Concomitant medication: prn Zyrtec; no known drug allergies; concurrent condition? / AE?: livedo reticular rash, all over body, on & off from May 2007, around time of vaccines; OTC cortisone cream ineffective; referred to rheumatologist for rash on 29-JAN-2008 - according to consult note, patient had the same rash on her feet "years before"; on 27-FEB-2008, a CT scan of the lung was performed.  2/2/09 MR received from PCP.  Hx as above. Rheum consult with DX Possible Raynauds. Livido reticularis-new onset. 04/07/09 This is in follow-up to report(s) previously submitted on 11/14/2008. Follow up information was received from physician via telephone call. The patient with no drug allergies was intramuscularly vaccinated with three doses of GARDASIL into the right deltoid on 07-MAY-2007, 02-JUL-2007, and 12-NOV-2007 (1st lot #657617/0384U, 2nd lot #657868/0523U, 3rd lot #659439/1267U), respectively. Concomitant therapy included prn ZYRTEC. In approximately May 2007, around time of vaccines, the patient developed livedo reticular rash all over body. OTC cortisone cream was ineffective for her. She referred to rheumatologist for rash on 29-JAN-2008. It was also reported the patient had the same rash on her feet years ago. On 27-FEB-2008, a CT scan of the lung was performed. Additional information has been requested.
I tested positive for COVID-19 on 11/02/22. I had congestion, chills, and a fever of 101. After a day and a half, I developed a sore throat and still had a fever. I called my doctor, and they prescribed molnupiravir. It is an alternative to PAXLOVID. I was unable to take PAXLOVID because of some other medications I take. I was better after 6 days, but it took 10 days before I tested negative. I started having some congestion a few days ago.
Pt developed a headache in AM 01/21/2011 which was constant for following three days and nights. On the evening of the fourth day post Zostavax (01/24/2011)@ 6:30 PM, Pt complianed of feeling that she was going to pass-out, became pale and clammy, began shaking uncontrollably and her heart rate increased from a normal 118/75, Pulse 80 to 220/110 Pulse 132 heart was bounding. She was admitted to ED.
A stroke less than a month after taking; Severe brain damage; Cant walk now; 2 aneurysms; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (A stroke less than a month after taking), BRAIN INJURY (Severe brain damage), WALKING DISABILITY (Cant walk now) and ANEURYSM (2 aneurysms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (A stroke less than a month after taking) (seriousness criterion medically significant), BRAIN INJURY (Severe brain damage) (seriousness criterion medically significant), WALKING DISABILITY (Cant walk now) (seriousness criterion medically significant) and ANEURYSM (2 aneurysms) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (A stroke less than a month after taking), BRAIN INJURY (Severe brain damage), WALKING DISABILITY (Cant walk now) and ANEURYSM (2 aneurysms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.  Company Comment: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected events of Cerebrovascular accident, Brain Injury, Aneurysm, and Walking Disability. The events occurred approximately within a month after a dose of mRNA-1273 (Moderna covid-19 vaccine). It's unclear if it was first or second dose. The rechallenge was not applicable as events occurred after a dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected events of Cerebrovascular accident, Brain Injury, Aneurysm, and Walking Disability. The events occurred approximately within a month after a dose of mRNA-1273 (Moderna covid-19 vaccine). It's unclear if it was first or second dose. The rechallenge was not applicable as events occurred after a dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Second day after shot - severe headache, extreme pain in joints, and later shaking.  Day 10- in the arm where the shot was given feeling of numbness that circled around the arm.
18APR96 several hr p/vax passed out, pale, cyanotic 4PM-ER visit showed pt nl;
mom reported to clinic 31JUL91 had swelling on lt thigh, & high temp 105 went to hosp 4JUL91;
Routinely high blood pressure (140/90) and palpitations (110+ bpm) for multiple months. Benzodiazepine and muscle relaxant medicines for multiple months. After 6 months from inoculation, there is no symptom.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Got shot 2:09pm pt had vision loss, sweating, low bp after recieving shot. 1st bp: 120/50 pulse 51 at 2:23pm, 2nd bp: 97/56 pulse 52 at 2:34pm, 3rd bp:97/47 pulse 54 at 2:48pm. advised pt to not drivr had friend leave with him at 2:50pm
Chills, nausea, body aches across my back plus both arms, severe arm pain where I received the vaccine - I could barely move that arm. I?ve never been shot with a bullet, but that?s what it felt like if I could imagine such a thing. I had general malaise, as if I were coming down with a horrible sickness.  It lasted until Friday, the worst days being Wed and Thurs.
This spontaneous report as received from a medical assistant concerning an 11 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 21-AUG-2014, the patient was vaccinated with improperly stored GARDASIL, (Lot number K001500; Expiration date: 16-NOV-2016) (dose, frequency, strength not provided). Co-suspect or concomitant therapies were not reported. This is one of several reports from the same source. Additional information has been requested.
Covid monitoring documentation. PT admitted 1/8/22 documented to have positive covid. PT received Moderna 1/19/21 Lot 012L20A for dose 1. Dose 2 was Moderna given on 2/18/21 Lot 031L20A.
Patient is 12 years old and mistakenly received Moderna Covid-19 vaccine instead of Pfizer. No known harm to the patient.
Brother had a sore arm; Could not go to work next day; Extremely tired after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Brother had a sore arm), JOB DISSATISFACTION (Could not go to work next day) and FATIGUE (Extremely tired after receiving 2nd dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Brother had a sore arm), JOB DISSATISFACTION (Could not go to work next day) and FATIGUE (Extremely tired after receiving 2nd dose). At the time of the report, PAIN IN EXTREMITY (Brother had a sore arm), JOB DISSATISFACTION (Could not go to work next day) and FATIGUE (Extremely tired after receiving 2nd dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication and treatment information were not reported.  The case was crosslinked to MOD21-057208 & MOD21-057247
Patient received Fluzone High Dose Quadrivalent instead of Fluzone Quadrivalent.
PFIZER Covid-19 vaccine LOT# EW0151 EXP. 07/2021 was reconstituted with 1.8ml of JANSSEN Covid-19 vaccine LOT#043A21A EXP. 06/21/2021 instead of the Sodium Chloride 0.9% (18mg per 2ml) diluent provided for reconstitution. Individual was given 0.3ml IM left deltoid of incorrectly reconstituted vaccine.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "polycystic ovarian syndrome" (unspecified if ongoing); "hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/12/21, Friday afternoon around 2:30pm, I noticed my left eye didn't feel right. I looked in the mirror and my left eye was slightly red in the corner of my eye towards my nose. When I woke up this morning on 3/13/21, my eye was completely red in that same corner of my left eye. I went to the a walk-in clinic this morning to have it checked out. The doctor indicated that it was a burst blood vessel in my eye and that the redness should go away in about a week. My BP was 148/100. The doctor asked if I had a history of high blood pressure and I told him no and showed him 3 of my previous BP card records that I keep in my purse. He said I should monitor my blood pressure and follow up with my primary care doctor. I have had a blood vessel burst in my eye before a few years back. I do not remember which eye. I have had fibromyalgia for over 20 years. I was diagnosed with Occular Myesthenia Gravis in January 2017 which affects my left eye only.
1-2 mm thin-walled vesicles noted on shoulder anterior to injection sites 2 days after injections of HPV & Influenza. No fever, rash, or other systemic symptoms.
Telogen effluvium hair loss; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 at 12:00 (Lot number: EW0168) at the age of 25 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7534; Anatomical location: Left arm; Administration time: 11:00), administration date: 25Apr2021, when the patient was 24 years old, for COVID-19 immunisation.  The following information was reported: DIFFUSE ALOPECIA (non-serious) with onset 01Aug2021 at 15:00, outcome "not recovered", described as "Telogen effluvium hair loss". The event "Telogen effluvium hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diffuse alopecia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.
02/08/2021: small (1 inch diameter) rash on right arm 02/09/2021: 3 large (4-5 inch) rashes on right arm around where injection occurred but not at injection site. Rash "fanned out" to right, left and above injection site area. Rash is not itchy but is warm to the touch.
Constant dull headache, left chest pain, shortness of breath, fatigue, and blurred vision
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On an unspecified date, 2 patients each received a dose of ZOSTAVAX (lot#, dose and route unknown). Then, on an unspecified date after this, these 2 patients both developed cellulitis. The present status of these patients was unspecified. All of the data listed here was reconfirmed with the reporter. Action taken was not provided. No PQC (Production Quality Control) involved. Additional information has been requested.
On 05/06/2002 at 8:30 am phone call received from the daughter of the pt stating that the pt was admitted to the hospital on 05/02/2002 for paralysis from the "neck and below." She also started that the doctor said "the paralysis was due to the MMR vaccine that was given on 04/22/2002." On 05/09/2002 at 3:30pm, spoke with the neurologist and he stated that the pt had Guillain-Barré syndrome with polyneuropathy and diminished reflexes. She complained of severe neck stiffness. The lumbar puncture and MRI results were normal per MD. Dr stated that he informed the family that he would "investigate if the symptoms are related to the MMR vaccine. I never said that it was directly related to the MMR vaccine."
CHILLS, VERY SHAKY, ANXIETY, VERY TIRED.  All began within four hours of injection.   Worse 10 hours later  Have been persistent the last 48 hours.
Myocarditis requiring transfer to higher level of care and hospitalization x 24 hours, continued mild chest pain.
redness under the armpit; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and ERYTHEMA (redness under the armpit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (soreness). On 02-Feb-2021, the patient experienced ERYTHEMA (redness under the armpit). At the time of the report, PAIN (soreness) and ERYTHEMA (redness under the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Patient reports ongoing gastrointestinal dysfunction with frequent, loose, and urgent stooling.  Has been placed on Metamucil which has decreased frequency but has not improved urgency or consistency of stooling.  Symptoms came on 2 weeks after receiving his 5th dose of the Pfizer vaccination.  Date was verified with the patient's vaccine card.  He has also reported erectile dysfunction and decreased libido since this booster was received.  No changes were previously made to his medical regimen to his recollection or according to my available records.
NO ADVERSE EVENTS REPORTED. PARENT REQUESTED THE PFIZER BIVALENT BOOSTER (AGE 5-11) AND 4-YEAR-OLD PATIENT WAS INCORRECTLY ADMINISTERED THIS VACCINE. FIRST TWO SHOTS IN THE VACCINE SERIES WERE CORRECT.
GOING TO DIE; 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 previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced going to die (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of going to die was not reported. This report was non-serious.
Presented to hospital on 7/12/21 with severe thrombocytopenia that was initially responded to corticosteroid. Patient was discharged on tapering prednisone regimen and readmitted again on 7/30 for severe thrombocytopenia. For 7/30 admission patient received IV Solumedrol 1gm x2 and IVIG 1 mg/kg x2 doses with tapering prednisone on discharge
Patient was given vaccine dose without added diluent. Given 0.2 mL (equaling about 3x recommended dose for age). Has had fever, vomiting, diarrhea since then. Unable to tolerate any fluids.
Case number PHEH2016US023358, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 36 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage).
Information has been received from a certified medical assistant concerning a 13 year old white female with no pre-existing allergies, birth defects, or medical conditions who on 07-AUG-2008, was vaccinated with the second dose of VARIVAX (Merck) (lot # 660495/0431X) subcutaneous route, left arm.  There was no illness at the time of vaccination.  On 08-AUG-2008, the patient experienced swelling and redness at the site of injection.  The patient was told to use ice MOTRIN and TYLENOL for comfort.  Was told to call back in 24 hours if not going down and they never called back.  On 09-AUG-2008, the patient recovered from swelling and redness.  Additional information has been requested.
Information has been received from a physician concerning a male patient with a history of chilhood chickenpox and no recent history of exposure to chickenpox of herpes zoster,who was vaccinated with the first dose of zoster vaccine live (Oka/Merck) at a local pharmacy 6 months ago, in approximately November 2007. In May 2008, the patient came into the physician's office with a mild case of shingles. There were 3-4 clusters papulovesicular lesions mostly distributed on the right chest (T3-4). The patient rated his pain at 1 on scale of 0 (least) to 10 (most). There were no other systemic symptoms. Subsequently the patient recovered. No fluorescent antibody or specimen were collected. No product quality complaint was involved. Additional information is not expected.
Acute metabolic encephalopathy, BPH with urinary obstruction due to blood clot. Patient was vaccinated at a pharmacy with Janssen covid-19 vaccine and experienced headaches and dizziness. Then began to have urinary retention which was believed to be due to a large blood clot requiring 12x 100mL flushes. Patient went to ED at medical center on 3/30/21 and was admitted. He was discharged to nursing home on 4/11/21.
Fever, malaise, nausea (started day 3). Highest Temp 101.6 F. No treatment. Symptoms gone on day 6.
Information has been received from a physician concerning an infant who was vaccinated with the third dose (completed series) of Rotateq after the age of 12 months.  No symptoms were reported.  There was no product quality complaint.  This is one of several reports from the same source.