chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constant nagging headache on the left side of the head with eye pain; Constant nagging headache on the left side of the head with eye pain; Pain on the left side of the chest; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 10:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and bipolar 2. It was unknown if the patient had any known allergies. Prior to the 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. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), buspirone (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 17Apr2021 at 12:00, the patient experienced constant nagging headache on the left side of the head with eye pain and pain on the left side of the chest. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events constant nagging headache on the left side of the head with eye pain and pain on the left side of the chest was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored oral ROTATEQ (lot # L039638, expiry date: 23-AUG-2017 or lot # M007124, expiry date: 05-OCT-2017. No adverse effect were reported. Follow up information was received from the nurse practitioner referring to a patient of unknown age and gender. On 31-AUG-2016, the patient was vaccinated with improperly stored  ROTATEQ, orally, lot # M007124, expiry date: 05-OCT-2017 (strength and dose number were not reported). This is one of the several reports received from the same reporter. Additional information has been requested. Patient, product and narrative were updated.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced injection site swelling. The patient received a dose on 20-Jul-2010. The patient experienced injection site swelling in Jul-2010. It is unknown if patient received treatment for event. As of 22-Jul-2010, the outcome of the event was unknown. No additional information was available at the time of this report.
Information has been received from a nurse who reported that a dialysis patient inadvertently received a dose of PNEUMOVAX 23 on 08-DEC-2014 which expired in August 2014. This was supported. In addition the patient had previously received a dose of PNEUMOVAX 23 on an unspecified date last year. The nurse declined to report this adverse experience, therefore information is minimal. No adverse effects reported. No further information provided. Additional information is not expected.
31 hours after receiving my 3rd Covid booster vaccine I started to have severe itching on my face. My face started to swell and turn red in color like I was flushed. No blisters or bumps occurred on the face. It then moved down my neck with redness and itching. I could not stop itching and it was too late to get Benadryl, so it was a miserable night! I slept for only 2 hours trying to control the itching and redness with cold wash clothes, calamine lotion and ibuprofen. At 8:00 am my husband went to get me Benadryl and that helped the itchy to a point. I was still swollen and red that next day. The following day my face began to peel. I stopped taking Benadryl and applied my  lotion to my face, as I do each day and night. The redness, mild itching and peeling continued for 1 week! I have never had a reaction to a Moderna vaccine until this shot in the series.
PT received MMR, Varicella, and Comvax on 2/18/03. PT presented to ER that evening w/congestion, eye swelling and hives. PT seen in office 2/19/03 w/only mild eyelid swelling, no hives or rash at site of injection. PT also given milk for 1st time 30 mins prior to episode. PT referred to allergist to help determine cause of reaction.
Idiopathic thrombocytopenic purpura and platelet count decrease to 1000.
0.3 ml pf Pfizer undiluted vial was administered to the patient by mistake.
Pt recv vax on 2/12/99; 2 hr post vax pt exp swollen lips; tx=Benadryl
Peripheral Neuropathy...It began with tingling in my feet in August 2021 then progressed over the next month to my arms, legs and torso.  In addition to tingling, it began to feel like pin pricks and burning and has become somewhat painful...peripheral neuropathy.   It is constant without relief by changing positions, clothes worn or ibuprofen taken to relieve pain.
This spontaneous report was received from a female consumer reporting on her 82 year old mother with LYRICA allergy and a pertinent medical history of breast cancer at age 74, lumpectomy and radiation treatment performed for the cancer at unspecified date, who on 11-JUL-2012 was vaccinated with ZOSTAVAX, 0.5 ml subcutaneous injection (0364AE, expiration date was not provided). No other co-suspects were reported. Concomitant medications included unspecified pain medications. The consumer stated that her mother experienced shingles on 25-JUL-2012: about two weeks after getting a ZOSTAVAX. The consumer went to the hospital and was hospitalized from 25-JUL-2012 to 26-JUL-2012. The consumer was given prednisone, triamcinolone and VALTREX as treatment for the event. Annual check-ups were performed as lab tests and the results were not provided. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Peed myself twice today, once in the morning and once in the afternoon. I had no control at all & I have never had this happen before. I had no sensation of peeing, it just flowed on it own volition.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 74-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), for COVID-19 immunization. The patient had a headache (outcome unknown). Additional information: The patient reported she was in excellent health. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient  reports a few hours after 1 st dose of COVID vaccine she noticed a spot of blood in left eye that progressively worsened a few hours after COVID Vaccine on 11/29/21.  She now has subconjunctiva hemorrhage to left eye medial aspect of conjunctiva.  Developed Fever, joint pains, headache 11/30/21.  Denies pain to left eye, but reports pressure.  Denies change in vision or blurry vision.  Denies contact lense use.  Reports wears glasses.
Prior to the vaccination, it seemed as if the patient was a nervous about getting the vaccination because he stated he had never received a "flu" vaccine prior. After the vaccination, the patient immediately sat down and began to sweat, grow pale, and feel clammy. Five minutes later, the patient passed out for a minute and then woke back up and was semi-alert/oriented; however, the patient passed out again several seconds later and woke back up. 911 was immediately called and EMS arrived on the scene. Patient's blood pressure was taken and was dangerously low. Patient was taken by EMS to the nearest hospital, where he is at currently.
At 4 month and 6 month shots mother states baby ran fever 103-104 into emergency room day after shot. Hx of vomiting and consolable crying.  1/22/07 Received medical records from hospital which reveal patient admitted 12/16-12/17/06 with cough & fever.  Treated w/IV antibiotics & responded well.  Afebrile all throughout hospitalization.  Patient was d/c to home on oral antibiotics for additional 10 days & to f/u w/PCP.  Patient had been seen in ER on 10/3/06 & 10/6/06 for RML pneumonia.  FINAL DX: Pneumonia.
Dad called approx. 17:00 to state that pt had immunizations 1 1/2 hours ago and now has a rash, hives, eyes swollen shut, coughing and drooling. The RN instructed parent to call 911 immediately. The pt went to the Medical Center.
On day about 11 after vaccine administration, started with redness, swelling, firmness and itching at the site of injection. Antibiotic was prescribed and OTC Antihistamines were recommended.
Information has been received from a physician concerning a 27 year old female, who in August 2007, was vaccinated with a 0.5mL first dose of Gardasil. Subsequently, 6 weeks post vaccination the patient experienced numbness in her feet. The patient went to the hospital and was diagnosed with "acute multiple sclerosis" and "acute demyelinating encephalomyelitis (ADEM)." The length of the hospitalization was unknown. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. The numbness in her feet and the acute multiple sclerosis were considered to be disabling. Additional information has been requested.
Started with stabbing pain in right side chest/abdomen in mid afternoon of 9/15. Woke up on 9/16 with shingles rash on right side which itches intensely. I've had Zostavax and Shingrix vaccines. Taking Valtrex 1gm 3 times daily for 7 days. Now rash much better, scabbed over and only slightly itchy.
During the early morning following my second Covid vaccination, I started having fever and chills, muscle aches, and a headache. I woke up about 230 am and my stomach was hurting.  I thought I would have to have a bm in a little while but was able to go back to sleep.  About an hour and a half later, I again woke up with stomach pain, maybe some bloating.  I decided to go into the bathroom and I sat on the floor beside the toilet and began vomiting.  I vomited 5 times and had one dry heave.  The vomitus was clear in color, thin with some small pieces of food.  I had felt very hot before vomiting, but was unable to check my temperature due tp nausea and vomiting.  I checked my temperature a little while later and it was 100.2 F.  I was able to go back to sleep for a while and kept checking temperature during the day.  It was between 99.1 and 99.8 for most of the day.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALOPECIA (Got a bald spot on his head/different bald spots all over his body/All of his hair is falling off including the hair on his arm, eyebrows, and head/When he puts on his glasses, his hair will be falling off) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 016B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Got a bald spot on his head/different bald spots all over his body/All of his hair is falling off including the hair on his arm, eyebrows, and head/When he puts on his glasses, his hair will be falling off). At the time of the report, ALOPECIA (Got a bald spot on his head/different bald spots all over his body/All of his hair is falling off including the hair on his arm, eyebrows, and head/When he puts on his glasses, his hair will be falling off) outcome was unknown. No concomitant medications reported. Treatment information included natural herbs and a bottle of vitamins/natural remedy for skin and hair that was recommended by patient's doctor.
Onset at 10 am 12/07/06: muscle weakness, aching later in the evening, fever of 102 F with nausea and flu like symptoms, no vomiting or diarrhea, next am 12/8 awakened with headache all other symptoms resolved.
I've complained to my docter since it happened. They wouldn't listen to me and tried to tell me it was parkinson's when there is NO test for it. They refused to believe me that it was connected to the vaccine. It became worse after getting the booster in Sept. 2022. I cannot fill out some of this form. It contains odd fonts that show as 2 fonts - one on top of each other. See box 21 where it is required... IT IS UNREADABLE.
Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 52-year-old male patient received BNT162b2 (BNT162B2), on 25May2021 as dose 1, single (Batch/Lot number: unknown), on 14Jun2021 as dose 2, single (Batch/Lot number: unknown), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 28Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Refractory Multiple Myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 18Jul2022, outcome "recovered" (23Jul2022) and all described as "Positive COVID-19 test".  It was reported that the patient tested positive for COVID-19 on 18Jul2022 and started Paxlovid x5 days from 18Jul2022. On 22Jul2022, patient had chief complaint of fever and SOB, and intermittent coughing and was admitted on 23Jul2022. Viral/post-viral (COVID) bronchitis suspected - grade 3 (Pulmonary consult was obtained and COVID-19 related bronchitis was suspected). No evidence of bacterial PNA or other bacterial infection was found. Pt continued to improve clinically. COVID-19 test on 23Jul2022 negative. Patient with bronchitis related to covid-19 was given IV antibiotic cefepime and discharged on 25Jul2022 and was on augmentin x5 days. Patient was discharged home on 25Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) positive; (23Jul2022) Negative. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, and considering the safety profile, there is a reasonable possibility of a  contributory role between the reported adverse events and the suspect  product BNT162b2 (BNT162B2).
vasovagal syncope. onset less than 10 seconds after administration. loss of consciousness for 2 minutes. no other symptoms during loss of consciousness. had slight headache after coming to.
A 71 year old female reported that she received an injection of Tetanus Toxoid Adsorbed, on 09/15/98 and a few days later, reportedly developed a red, itchy rash "all over" her back and arms. The patient reportedly recovered within 10 days. Additional information received from the physician on 05/24/00 indicated that the date of vaccine administration was 09/15/98, and the onset of the erythematous rash was 09/23/00. The patient remained recovered. Manufacturer's Comment: The lot # was reported as 0918970; however, this is not a valid Lederle lot number.
On day 10 arm started turning very red and painful. Redness continues spreading up and down arm until up above shoulder and almost to elbow.  To ER on Sunday.  Said use Tylenol and cold packs.  By next Friday almost all redness gone but upper arm and shoulder are now very painful.  No issues with arm until day 10
Information has been received from a physician concerning his 3 year old female daughter who on approximatley 08/15/2001 was vaccinated with varicella vaccine. Two to three days after the vaccination, on approximately 08/17/2001, the child developed hives which "continuously come and go." Additional info has been requested.
Patient received Janssen COVID vaccine on 8/19/21 at another facility. On 9/24/21, patient tested positive for COVID with 8 days symptoms of SOB and generalized weakness. Patient admitted to our facility from 9/24/21 to 9/27/21 with main indication acute respiratory distress due to COVID pneumonia.  Patient received dexamethasone and remdesivir during hospitalization and was discharged home on 9/27/21.
postherpetic geniculate ganglionitis: sore throat, a metallic taste in her mouth and pain in swallowing; Information has been received from a lawyer on regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or around 10-JAN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered a sudden and severe sore throat, a metallic taste in her mouth and pain when swallowing. she was diagnosed with postherpetic geniculate ganglionitis (geniculate ganglionitis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms have resulted in physical limitations which were not present prior to using this vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanente and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At reporting time, pt was not recovered from geniculate ganglionitis and this event was considered to be related to zoster vaccine live (ZOSTAVAX) vaccine. Geniculate ganglionitis was considered to be a disabling event.
High pitch ringing 3 days after first pfizer vaccine. Ongoing.  Also had pressure in lower jar but that has gone away.
"Seizure-like episode", legs twitching, eyes rolled back of head. Pt was wide awake, whole episode lasted 30 seconds.
One week after the shot, my right shoulder started itching at the injection site.  I absent-mindedly started rubbing/itching it through my shirt.  As day wore on (Thursday, Feb. 25), it became more and more noticeable and distracting.  I removed my shirt that evening and discovered my entire outer shoulder was swollen, inflamed, and VERY itchy.  Benadryl didn't help, nor hydracortizone cream, nor wet washcloth with soda.  I finally discovered that a "rice bag" from freezer brought the most relief.  Friday the redness and swelling was going away but I had to keep from touching it or it would set off the itchies.
Since the day after the injection I have had chronic fatigue, severe nausea, sore throat, and body aches. I had some rashes and was super itchy for a few days. But, the fatigue, nausea, body aches has lasted this whole time. I have had both Covid tests and I am negative. Also, blood work and a chest x-ray. Everything is clear and normal. But, I still feel so horrible. It really sucks.
A nsg reported that a pt who rec'd his 5 injection of Acel-Imune, with MMR (manufacturer unknown) and IPV (manufacturer unknown) on 3/23/01. On an unspecified date, the child experienced pea-sized subcutaneous nodules at the site of injection lasting for months. The nodules were noticed on 5/21/01. The nsg reported this same event occurred in the child's twin brother (see case HQ2168118JUN2001) No further info was available at the date of this report.
shot occurred on 1 MAR.  swollen lymph nodes in the right armpit began to be noticeable around 3 MAR.  Pain and inflammation in left arm pit did occur off and over the next two weeks.  Blood work and revealed no significant issues.  Follow on ultrasound 23 MAR still showed some inflammation and sensitivity.  by today, 30 Mar the majority of the swelling is gone and pain has dissipated.
Evening of the next day after the shot her left bicept was erthymous, inflammed, and warm to the touch. She has had taken some tylenol the morning after the shot and had iced the shot the evening after the shot.
Two hours post vax the patient experienced chills, fever, myalgia and sore arm at injection site.  The symptoms were treated with ibuprofen 600 mg. The information received on 30-March-2000 reported the symptoms resolved except for the sore arm.
Swelling, chill, and muscle spasm on her right leg and foot about 9-10 days after receiving her 1st dose Moderna vaccine on 5/13/2021
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 22-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  This case was linked to MOD-2022-501575 (Patient Link).