chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 09:00 as dose 4 (booster), single (Lot number: GJ6/42) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; SYNTHROID; CETIRIZINE; DAPSONE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 17Nov2022 at 06:30, outcome "not recovered" and all described as "Extreme dizziness and tired"; ACCIDENT (non-serious) with onset 17Nov2022 at 06:30, outcome "not recovered", described as "Had an accident on the way to work".  Additional information: The patient had no known allergies and had not been tested for COVID-19 since vaccination.
BLACKED OUT; This spontaneous report received from a 33 year old female patient via a company representative. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included egg retrieval and was also on prescription pain relievers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total administered on 06-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-JUN-2021, Around 3:00 pm, patient was in bed with chills and soaking with sweat. Patient stood up and immediately started losing vision and hearing. Patient felt like was going to faint and felt like may had blacked out for a bit as when patient came and was standing in another part of home and does not remembered how she got there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blacked out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210617061-COVID-19 VACCINE AD26.COV2.S-Blacked out. 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).
5-10 minutes post injection, pt complains of itching to face. Pt not scratching face. No hives, rash or redness noted. No mouth swelling. Pt denies difficulty breathing or swallowing. Pt instructed to remain in clinic an additional 15 minutes.
menstrual cycle started 4 days early with heavier than usual flow; Myalgias; Chills; Tmax 100.7; This is a spontaneous report from a contactable physician reported for herself. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142), intramuscular in the right arm on 08Jan2021, 15:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have Covid prior to vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included multivitamin. The patient previously took amoxicillin and experienced hypersensitivity (reported as known allergies to amoxicillin). The patient received the first dose of bnt162b2 (lot:EK5730), intramuscularly in the right arm on 18Dec2020 at 11:00AM at a single dose for covid-19 immunization. The patient experienced myalgias, chills, tmax 100.7 on 09Jan2021 09:00. It was also reported that patient's menstrual cycle started 4 days early with heavier than usual flow on 09Jan2021 11:00. Patient did not received treatment for the events. The outcome of the event myalgia, chills and pyrexia, was recovered on 09Jan2021, 21:00 and recovered on an unknown date for the event menstrual cycle abnormal. Patient was not tested positive for Covid-19 post vaccination.
Fever of 104 11 days later with no cause; No other symptoms, No rash.
Patient fainted and fell out of chair and struck face on floor. He was unconscious for approximately one minute and sustained a laceration to his nose and mild bruising. He was sent to ER and was examined approximately one hour later. He had an EKG performed which was normal and dermabond was used for laceration on his nose. He was discharged to home.
HIGH FEVER, UNCONTROLLED SHAKING, DIZZINESS, SHORTNESS OF BREATH WITHIN AN HOUR OF IMMUNIZATION. FATIGUE AND EXTREME WEAKNESS IN RIGHT ARM X 3 DAYS. RASH BILATERAL LOWER EXTREMITIES (2 DAYS LATER AND CONTINUED FOR APPROXIMATELY 3 DAYS.
Patient experienced brief moment of dizziness, then lost consciousness and experienced an apparent epileptic seizure.  Patient recovered on own approximately 2 minutes after administration. EMS were called, patient left with parent after evaluation by EMS.
Information has been received from an office manager referring to an unspecified multiple number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017 and/or lot# L006547, expiration date 04-MAR-2017, strength, dose and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Stroke 3 weeks after receiving first dose; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 09Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced stroke 3 weeks after receiving first dose(on 01Apr2021). The patient was hospitalized for 15 days. The patient underwent lab tests and procedures on 03Apr2021 which included nasal swab (for sars-cov-2) test with negative results. The outcome of event was reported as not recovered. The patient did not receive any treatment for the event. The event was considered as serious, resulting to emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and disability or permanent damage.   Information on about lot/batch number has been requested.
Patient started having rash on his feet the same day and it was getting all over his body and also started swelling. he was even hospitalized. dr recommended not to get the second dose of covid vaccine
COVID 19 Treatment; COVID 19 Treatment; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRAZODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; OFF LABEL USE (non-serious), outcome "unknown"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Treatment of COVID-19; (Dec2022) Negative; (Dec2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received paxlovid for COVID 19 Treatment from 17Dec2022 to 21Dec2022. Rebound case. Tested negative, felt better for a day or two and then tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Acute deep vein thrombosis of calf vein of lower extremity. Pt had calf pain and swelling. Started 9 days post injection.
immed following vax pt redness & a couple of days later bruising at inject site. f/u pt exp redness & tender pancake-like swelling at inject site.
The night of the vaccination pain got bad and was constant. The patient described it as a throbbing pain and She described is as "It felt like someone punched me in the arm." The patient has been continuous since onset. She has limited range of motion. Injection site didn't appear reddened warm to touch or swollen. She was referred to the Emergency Dept. for further evaluation.
He has had a friable capillaries, so sometimes when he urinate, he urinate blood or little blood clots; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for Atrial Fib (atrial fibrillation). Medical history included prostate cancer from about 10 years ago and was treated by radiation, the radiation has caused capillaries in the penis to be fragile (friable capillaries) and there were times when he bleeds and has some clots and it usually resolves itself; and bloody urine in the past. The patient's concomitant medications were not reported.. Radiation has caused capillaries in the penis to be fragile and there are times when he bleeds and has some clots. The patient has had a friable capillaries, so sometimes when he urinates, he urinate blood or little blood clots. The patient was on Eliquis, so yesterday when they came home after he got the vaccine, he was bleeding with the clots which he has done in the past. The reporter asked if it is possible that the vaccine can precipitate a bleeding episode in someone that is on Eliquis and had on and off had bloody urine in the past. After the shot, he was bleeding with the clots and with the bloody urine. The patient got the first dose of the Pfizer COVID-19 vaccine on Wednesday. He had radiation for prostate cancer 10 years ago. He had a bloody urine periodically and the doctors were aware. He had a blood urine one hour post vaccination in 24Feb2021. It would take at least a few hours for the medication to get in the system before having any kind of reaction. It resolved on its own he doesn't have a blood urine anymore. The second dose of the vaccine is due on 16Mar2021. The action taken in response to the events for apixaban was unknown. The outcome of the events was recovered on unspecified date in Feb2021.
Patient came into the pharmacy to receive a HPV(Gardasil) vaccine but received a Covid 19 (Pfizer Biontech) instead.  No adverse effects have been noticed yet.
Within 1 minutes the pt exhibited a generalized seizure, eyes rolled back, BP 70/38 and pulse faint. The pt was cool and clammy with mild diaphoresis, and paleness. Seizure lasted 30-45 seconds, Pt was responsive. 911 and the parent called. The pt was taken to the ER.
Itching began about 12 hours after the second injection.  Followed by moderate patchy hives.  Treated with OTC Benedryl, Pepcid, and Zyrtec.  Had a decrease in itching and mild improvement in the rash.  At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice.  Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl.  Then on 2/20/2021 began to develop throat swelling and voice hoarseness again.  Sought the emergency room again for the same treatment list above.
27OCT98 approx 5PM pt noticed red & sl enlarged area @ inj site on lt upper posterior arm;warm to touch;28OCT98 AM pt stated had chills, fever, malaise, body aches;red area rt upper arm;red & swollen;inc chills & fever & red raised rash;saw
Mother states following patient receiving MMR and Varivax in the same left thigh, patient's leg was red and swollen.  She finally called when it didn't resolve and got an appointment for today. He did have some mild limping. She did not treat it, as did not know what to do.  Today he is fine, without swelling or redness and walking without problems.  Denies previous vaccine reactions.
I had an heart attack May 13th, 2021. Hospitalized for 2 days. Treated medically with no surgery and no stent. Was diagnosed as myocardial bridge.
Within 30 seconds of receiving a flu vaccine at a drive thru flu clinic, the patient became lightheaded.  He pulled his vehicle to the side of the traffic lane. Approximately 90 seconds later the patient lost consciousness.  He was with a trained medical responder, who called for assistance.  His vitals were taken and a physician was immediately on site and examined him.  He determined this was a vaso-vagal reaction.  Patient stated he has had issues with being light headed with previous medical procedures involving needles.
Pt felt dizzy, clammy, sweaty immediately after receiving Janssen vaccine. EMS was called and pharmacist and store managers waited with her until they arrived. Pharmacist suspected she had fainted.  She was responsive and aware, vitals wnl. After about 15-20min with EMS, patient felt better and was encouraged to eat and drink something before leaving.
Missed the second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. The VAERS details were reported for 1st dose of Shingrix.
On Tuesday, 09/03/2019 I took my healthy 1 year old daughter for her 12-month visit where she received the recommended dose of Varicella. The injection was administered by her Pediatrician to the left upper thigh. By Wednesday, 09/04 evening my daughter became febrile with a fever that spike to its highest 104°F by Thursday 09/05/2019 which was associated with shivering and loss of appetite. The fever persisted despite of oral Tylenol and Motrin given to my daughter. Finally, her pediatrician administered a rectal suppository in the office on 09/05 which helped to reduce the fever, however, it did spike again that evening. The fever lasted until Saturday 09/07 and my daughter began to show signs of improvement by Sunday 09/08. Monday 09/09 my daughter developed what I thought were cold symptoms which included cough, congestion and runny nose; this lasted a week. On Sunday 09/15/2019 I noticed some inflammation at the site of her injection which I began to keep an eye on throughout the day; by Monday 3 vesicles were formed on her left thigh and one in the center of her chest. By Monday evening the vesicles continued to appear and the swelling at the injection site became more prominent. I took my daughter to an after hour Urgent Care on Tuesday 09/17 evening to express my concerns and all they could say was its viral. Keeping in mind that my daughter did not have nor has she developed any vesicles on her hands or feet, therefore, the prognosis of coxsackie would not apply. Additionally we co-sleep and I have not developed any symptoms throughout this entire time and coxsackie is extremely contagious. It is now September 20, 2019 and finally some of the vesicles on my daughter?s body are beginning to heal especially the ones at the site of injection. I will continue to monitor and keeping a diary along with photos to further assist with any information needed regarding this matter.
Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on affected side. No treatment appears to improve conditions.
After dose 2 I had symptoms of extreme fatigue and reported on separate VAEARS.  After dose 3, booster2, my fatigue was worse and continued.  I wanted more lab work done because I didn't believe it was just my thyroid issue as determined by Dr.  I saw my Natural Path Doctor.  She ran T3T4 and  looked more closely at my thyroid.  My fatigue was really bad. I would come home from work, got to bed, and get up the next morning.  I was tested for Lime Disease but it was negative.   T3 was low and treated but stopped treatment because I couldn't tell any difference.  After she ran more labs she found the Epstein Barr Virus had been reacted.  My symptoms are sleeping 10-12 hours a day, sweating and brain fog. My treatment is Epstein Barr Virus drops.  She advised me to eat Brazil nuts and seaweed.
Headache, Myalgia, Arthralgia, Fever,  chills Narrative: g. Symptoms experienced: 1/12/21 around noon just felt exhausted. Around 2000, fever ( 100.9 (had taken 500 mg po Tylenol prophylactically, chills, headache (not relieved with Tylenol), body and joint pain. Fever gone by morning of 1/13/21, headache gone by noon. Just feeling a little tired and achy overall now but able to return to work today.
Patient said:  I had COVID infection, very mild symptoms, just a runny nose. They gave me an antiviral medication and I took it for 5 days.
9-27-10 Influenza vaccine given (SEAS, H1N1, H3N2) 10-4-10 cornea rejected again (after corneal transplant). Aggressive steroid treatment started. Previous Hx: Age 50 10-09 H1N1 given - cornea rejected 12.24.09 (aggressive steroid treatment).
This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (testing positive for COVID after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 COVID-19 (testing positive for COVID after vaccination). At the time of the report, COVID-19 (testing positive for COVID after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.   No concomitant medications was reported. No treatment drug details was reported.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016463882) on 20-Oct-2016. This case involves a male patient (age not reported) who was vaccinated with INFLUENZA VACCINE (FLU VACCINE) (batch number, expiry date, dose, dose in series, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, unknown timeframe following the vaccination, patient developed allergy. Lab test and corrective treatment was not reported. The outcome of the events was not reported. Documents held by sender: none.
Received ZOSTAVAX on 1/7/10. Developed large rash and pain on left arm.
Shortly after receiving 1st HPV vaccine dose 1/23/12, developed diffuse hive-like rash, worsening despite antihist. Seen by allergist 1/26. Rash described as target like with features of erythema multiforme, requiring steroids.
Information has been received from an other health professional referring to unspecified number of unspecified patients. No concurrent condition or medical history was reported. On unspecified dates since 09-MAR-2015, the patients were vaccinated with doses of improperly stored (Merck) VARIVAX (dose and route were unknown), Lot# was reported as J014406 exp 13-NOV-2015, K026386 exp 15-DEC-2016, K001390 exp 29-JAN-2016, K010338 exp 22-JUL-2016). No adverse effects reported. This is one of several reports from the same reporter (1505USA005156, 1505USA003305). Additional information has been requested.
Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge tempts before + after. DOH determine the vaccine to be at risk + advised reporting + revaccination Child had no ill effects thus far
Vaccine received on Jan 18--  Jan 19th- body aches, fever,fatigue jan 20th- body aches, fatigue jan 21st-rash on left hand/arm- left arm pain
make people sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "make people sick".  Additional information: Reporter reported that pfizer sells products that make people sick. Reporter consider event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
As described by patient, "I had a reaction 10 minutes after I got it." Facility laid her down and monitored for 30 minutes [Reporter does not know details of this reaction.] No other adverse effects reported until 2 days later.  Patient reports that upon awakening (7/11/21), her near-sighted vision was very blurry and doubled.  Double/Blurry vision continued for multiple days, prompting an ER visit for workup, since patient unable to report to work with vision problems.  Patient was seen in ER on 7/14/21.  CAT scan unremarkable.  As reported by patient, "My cat scan looked okay.  They have me Decadron and it helped my vision some, so he's sending me home on steroids.  He said the immune system is in overdrive trying