chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up at about 5:00 am the next morning and I could not see out of my right eye. My right eye was burning and watering. The sclera was completely red, there was no white in there. I could only see light. I could not see shapes or read. It lasted for about 2 hours. I also had a headache and my heart was beating really fast and I had SOB. I went to the ER. By that time I could see again. I only felt some pressure in both eyes. They could not do anything there. They checked my vitals. My heart rate was 180 beats per minute. They made me stay for a couple of hours until my blood pressure and heart rate went a little lower but they could not get my blood pressure down. They released me and they said to follow up with an ophthalmologists. I called my PCP and she suggested a CT scan of my head. I came back clear. I went to an eye doctor a few days later. They did a bunch of scans. When I went that Monday they did a vision test, they checked the thickness of my cataracts, and the saturation levels in my eyes. The saturation level in my right eye is low and they said my optic nerve behind my eye had thicken. He said it was intercranial hypertension which they said they have seen it in other patients that have been vaccinated. At that point because I had some peripheral vision loss and the intercranial hypertension, they told me to go to a neuro ophthalmologist. I have had a headache ever since. I went to have my blood pressure and heart rate re-checked and it is still high so they put me on hydrochlorothiazide. On 09/27/2021 I will se the neuro ophthalmologist.
pt recvd vax;approx 4 days later,exp sore throat,fever ,swollen glands & aches;tx w/ amoxicillin w/out resolution of sx;blood tests showed mononucleosis;
Insomnia, then nausea, morning headache and muscle pain. Rt side sharp abdominal pain
ACUTE NON ST ELEVATION MI 8/12/2022 LONG TERM ANTICOAGULANT THERAPY  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/12/2022 LONG TERM ANTICOAGULANT THERAPY  HYPOXIA 7/5/2022 LONG TERM ANTICOAGULANT THERAPY  ACUTE NON ST ELEVATION MI 8/12/2022 LEFT INTERTROCHANTERIC FEMUR FX, DISPL INIT  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/12/2022 LEFT INTERTROCHANTERIC FEMUR FX, DISPL INIT  HYPOXIA 7/5/2022 LEFT INTERTROCHANTERIC FEMUR FX, DISPL INIT  ACUTE NON ST ELEVATION MI 8/12/2022 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/12/2022 ATRIAL FIBRILLATION, UNSPECIFIED  HYPOXIA 7/5/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Severe headache; Tired; Chills; Joint aches; This is a spontaneous report from a contactable consumer, the patient.  A 63-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via unspecified route of administration at left arm on 15Mar2021 at 13:00 as single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medications included fluoxetine, levothyroxine, omeprazole, and vitamin D3; all started on an unknown date for unknown indication and unknown if ongoing. The patient neither underwent test for COVID-19 nor was diagnosed with COVID-19 symptoms prior to vaccination. Since vaccination, the patient was not tested for COVID-19. On 16Mar2021 at 11:00, the patient experienced severe headache, chills, joint aches and was tired. No therapeutic measures were taken for the events. The clinical outcome of the events severe headache, chills, joint aches and tired was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (route, strength, dose and frequency were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Itching, burning rash around both eyes starting ~3 days after vaccine with improvement after 7 days of onset
Was fine after vaccine was given, 2 hours later arm was sore, 3 hours later face was flushed and felt warm. Started feeling off, 5 hours after receiving vaccine I had the chills and felt achy all over. Took 500 mg of Tylenol felt better but had a low grade fever 100.4. 12 hours after shot was given woke up at midnight chills, body aches, heart racing, chest felt very heavy, mouth was watering, felt a little nauseous. Chills got worse all night, shaking, teeth chattering, took temperature at 6:00am fever was 103.1. Felt terrible whole body ached, arm where injection was given was very painful to move.  Took 250 mg of Tylenol stayed in bed two and half hours later fever was lower 100.5. Body aches all day, bad headache that was all over my head, shoulders, arm where shot was given, and lower back were the most sore. Drank lots of water, Now 29 hours post vaccine no more fever but still body aches and headache. Took 250mg Tylenol. Slept fine woke up next day and only symptom was headache. 48 hours post vaccine.  72 hours after feel better just a  headache but tolerable.
pain in my left shoulder and I notice that about 3 days after I had my vaccination and the shoulder pain has gotten worsen ever; General muscle pain; My temperature is 95.8 Degrees Fahrenheit; pain in my shoulder has progressively got worse over the last week; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3249; Expiration Date: 31May2021) via an unspecified route of administration on 01Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included vitamin b12 injections and blood thinners. The historical vaccine includes BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced a pain in my left shoulder and I notice that about 3 days after I had my vaccination and the shoulder pain has gotten worsen ever, general muscle pain, my temperature is 95.8 Degrees Fahrenheit, pain in my shoulder has progressively got worse over the last week. The patient further stated that on 01Mar2021 about 3-4 days of second vaccination, patient developed pain in his left shoulder, and it has got progressively worst. The patient also felt like he got some other muscle pain and was just wondering if this was a reaction that he was having. The patient questioned whether it was common, or not a reaction. The patient questioned whether he must call Emergency room. The body temperature was 95.8 Fahrenheit. The events were assessed as non serious. The outcome of all events were reported as unknown.  No follow-up attempts are possible. No further information is expected
pt recv vax;devel fever,devel rash similar to chicken pox;seen by MD;MD thought pt had devel chicken pox 3 days p/ vax,pt was exposed to the live varicella virus 20 days earlier;
pt recv vax; fever 104; had couple of sz on 11mar96;still presently hosp for encephalitis;
Ringing in both ears.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 19Mar2021 at 13:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 12:00, approximately 7 days after first shot, the patient experienced ringing in both ears. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in both ears was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Developed watery stools 1 hour after IPV. Also developed increased temp 101.1 F, vomiting, and not eating well. As of 05/31/2005, child has had increased temp x3 weeks, vomiting for 15 days, watery stools x approximately 2 weeks, not eating well x 2 weeks. As of 05/31/05, child still has increased temp and is sleeping more than ususal.
3/10/03 Received smallpox vaccination.  3/17/03 Major take read 5/8/03 Reports noticing heart palpitations for previous 2 weeks.  The palpitations initally were once per day for 2-3 minutes, but gradually increased in frequency.  On 5/8/03 patient developed what she initially thought was 'stomach problems'.  Pain gradually increased in severity 'someone standing on my chest with a knife into my chest'.  Developed nausea and diaphoresis.  Taken to Hospital ER where she was admitted to the step-down unit with R/O MI.  Pain finally relieved with 5 nitroglycerin in ED. 5/9/03 Patient discharged as stress test could not be scheduled until 5/13/03.  Reported 'no heart damage'.  Enzymes were normal as was angiogram.  Reports a history of elevated cholesterol (232), hiatal hernia, GERD and depression. 5/12/03 Continues to have chest pain 3-4X/day./ Pt is hesitant to take nitro for chest pain due to resultant headaches.  Taking ASA and Lopressor 25 mg BID as prescribed in hospital.
Sore arm, slightly dizzy, achey, tired, horrible headache, slight nausea that lasted two days.
The patient was 17 at the time of receiving his COVID-19 dose of the Janssen vaccine. The patient experienced no adverse reactions and left after being observed for 15 minutes.
29 mins post vaccine pt complained of chest pressure. Pt monitored by provider and EMS - stable referred to ED for further evaluation
pt recvd vaxpt not responsive upon arrival at hosp; found in crib wrapped in blanket,not breathing;unable to rescuscitate;coroners case, pending autopsy report;
inner thigh with generalized redness more medially inward from injection to mid thigh size of orange, also noted imprint with redness where bandaid was at. Mom touching and does not appear tender or in pain.
Patient's upper arm was red and swelling to the extent her upper arm was twice the size of unaffected arm.
Loss of smell,  Nose smelled very ' bad smell' within a couple of hours after vaccination, particularly after 2nd dose of vaccination.  Since then, find loss of smell.  Thought this was just a short time minor side-effort, but the smell has not got any better after more than one year
developed "headache,chills, fever of 102.7,vommitting," "light red rash on arms, chest", described as "sunburn like". symptoms have not completely resolved. Took benadryl with relief
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  62-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 at 16:30 as dose 1, single (Lot number: ER8732) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (ongoing), notes: Onset date: Since childhood, Stop date: Ongoing, Pertinent details: no meds taken for many years.; "Osteoporosis", start date: 2012 (ongoing), notes: Diagnosed in 2012 during screening test. No fractures no medication yet.; "Prior post fever rashes after some illness", start date: 1990 (ongoing), notes: Onset date: 1990, Stop date: Ongoing, intermittent may be once every few years. Concomitant medication(s) included: CITRACAL [CALCIUM CITRATE] oral taken for osteoporosis (ongoing); VITAMIN D [VITAMIN D NOS] oral taken for osteoporosis (ongoing). Past drug history included: Thimerosal, start date: 1980, reaction(s): "Thimerosal allergy", notes: Onset date: Since early 1980, Stop date: Ongoing, Diagnosed by eye doctor due to thimerosal in contact lens solution. The following information was reported: RASH (non-serious) with onset 27Mar2021, outcome "recovered", described as "Each time I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and back after a few days"; PRURITUS (non-serious), outcome "unknown", described as "very uncomfortable itching for several days"; ERYTHEMA (non-serious), outcome "unknown", described as "redness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "disrupting sleep"; SOCIAL PROBLEM (non-serious), outcome "unknown", described as "making it difficult to socialize or plan activities". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash. Additional information: Each lime I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and bark after a few days. When the redness occurred, it felt like a minor sunburn, a little warm and uncomfortable. After the red went away, there was very uncomfortable itching for several days, even disrupting sleep, and making it difficult to socialize or plan activities (due to discomfort wearing regular clothing). This effect happened after Pfizer and Moderna doses. After the 4"' shot (20' booster, Moderna), I decided to report it, because I cannot take this anymore every months or each time we get a booster.
Mind wonderings at night, like visions or hallucinations; Misspelling issue; Arm sore; Burning aches, not just joint aches; Chills; Burning aches, not just joint aches; A spontaneous report was received from a consumer concerning a 65-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, arm sore/pain in extremity, chills, burning aches/pain not just joint aches/arthralgia, Mind wonderings at night, like visions or hallucinations/ hallucinations visual and misspelling issue/aphasia.  The patient's medical history provided included allergy to sulfa drugs, shrimps, enthesis and has non- alcoholic fatty liver and hypertension. Also, her grandmother experienced a condition with platters bleeding without clots. Concomitant medications reported included lutropin alfa, rosuvastatin calcium, bisoprolol HCPC, vitamin D3 and calcium.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) unknown route for prophylaxis of COVID-19 infection. On 13 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscular in the left arm for prophylaxis of COVID-19 infection.   On 14Mar 2021, the patient reported having arm sore, chills, burning aches not just joint aches, mind wonderings at night, like visions or hallucinations. Before falling sleep or waking up, patient had images of black and white live photos. She sees image with one eye, and they are not like a dream. When she opens the eyes, the photos disappear, but when closing again, the shots are in color and like cartoons or childish videogames. patient states that this is like a sleep pattern and that she has never been on drugs. She also has misspelling issues. She reported that while writing things down, she notices that are wrongly written and that letters are not coming easy to her mind. The patient states that she does crosswords all the time, so this was very strange for her. The event hallucinations was considered medically significant. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  At the time of this report, the outcome of the events, arm sore, chills, burning aches not just joint aches, mind wonderings at night, like visions or hallucinations and misspelling issue were unknown.; Reporter's Comments: This case concerns a 65 Y/O F with a serious unexpected event of visual hallucinations along with nonserious unexpected aphasia, pain, pain in extremity, and expected chills and arthralgia. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included influenza (experienced in 1992). On 26th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced fever, shivering, joint pain, injection site pain and feeling bad. The patient was treated with ibuprofen (Motrin). In November 2018, the outcome of the fever, shivering, joint pain and injection site pain were recovered/resolved. On an unknown date, the outcome of the feeling bad was unknown.  It was unknown if the reporter considered the fever, shivering, joint pain, injection site pain and feeling bad to be related to SHINGRIX. Additional details were received as follows: The patient never had chicken pox in the past. The patient reported that received a shot of SHINGRIX, the day before reporting. The patient had the worst night with fever and shivering as it was common. The patient don't want to receive the 2nd dose of SHINGRIX. The paperwork shows that SHINGRIX vaccine did not protect against chickenpox. The representative provided the information on SHINGRIX vaccine to the patient that the SHINGRIX vaccine is not contagious. However, the virus can be spread from a person to person with a shingles to someone who has never had chickenpox. The virus spread through direct contact with fluid from the blister. If the patient had chickenpox, that the they were 99 percent of people who already had the shingles virus inside. SHINGRIX was not a live vaccine. Once the shingles blister had developed crusts, they were no longer contagious. The patient said that she hadn't felt this bad as she had Flu in 1992. The patient never had blood titer that didn't pick up antibody.
04/08/2021- Day of shot, pain began and lasted over 4 weeks, went across my shoulder around my heart and down my arm, pressure, discomfort kind of pain. 04/11/2021 began having extreme dizziness. stabbing pains around hear while driving, lasted for 10 minutes. 05/04/2021 I woke and I had blurry spot in vision, more dominant in left but was in both eyes, then began to spread, last about half an hour, was left with headache, I went to ER. I started to get bloated, I am dealing with a lot of stomach issues. I have to see endocrinologist .
Mom called 11-21 stated he had 2 hot red swollen circles over immunization sites with welts and itching.
A nurse reported that a 37 year old female received a tetanus toxoid adsorbed (manufacturer unknown) around 1990 and subsequently developed a moderate reaction at the injection site. Reporter indicated that the pt was informed to be careful with future injections of tetanus vaccine. Follow-up information received from the reporter on 5/19/2000 provided the date of therapy and event onset. The patient recovered.
This spontaneous report as received from registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ, oral (dose, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. had a positive pregnancy test on 08/04/2014. LMP of 06/07/2014 and probable date of conception 06/21/2014.
First symptoms were severe back pain bent over when walking. Later pain in left shoulder and shortness of breath climbing stairs with heartbeat racing. Later developed pain in right thigh and calf. On May 30  emergency room determine blood clots in right leg and both lungs. First Symptoms appeared about one week after second dose on April 19
Early 5th dose of Daptacel was inadvertently administered with no reported AE; intended to administer Prevnar to the patient on 11 July 2018, but an early 5th dose of Daptacel was inadvertently administered instead, with no reported AE; Initial information was received on 25-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves an 18months old male patient who reported that early 5th dose of Daptacel was inadvertently administered with no reported adverse event, intended to administer Prevnar to the patient on 11 July 2018, but an early 5th dose of Daptacel was inadvertently administered instead, with no reported AE (adverse event) while receiving vaccine Diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB Vaccine (HIB Vaccine) for Immunisation.  The patient received first dose of suspect Diphtheria-15/tetanus/5 AC pertussis vaccine (formulation, strength, batch number, expiration date: unknown) via intramuscular route in unknown administration site on 02-Jun-2017, second dose on 03-Mar-2017, third dose on 19-Jul-2017, fourth dose via subcutaneous route on 30-Apr-2018 for immunization. On 11-Jul-2018 he also received a dose of the same vaccine (batch number: C5254AA, expiration date: 18-Sep-2019) via intramuscular route in the left vastus lateralis for immunization  On 11-Jul-2018 the patient reported that early 5th dose of Daptacel was inadvertently administered with no reported adverse event (product administered to patient of inappropriate age) and intended to administer Prevnar to the patient on 11 July 2018, but an early 5th dose of Daptacel was inadvertently administered instead, with no reported AE (Wrong product administered) (latency: 1 year 4 months) following the administration of Diphtheria-15/tetanus/5 AC pertussis vaccine.  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had breakthrough menstrual bleeding with first vaccine but it stopped and when she rcvd her second vaccine later that day she started menstrual bleeding again and as the days went on it became heavier and heavier with big blood clots. She not stopped bleeding in 20 days.
Pt recvd Engerix-B vax & w/in 1/2 hr to 45min pt exp hypertension; tx w/DPh in ER; no epi given; reporter indicated event was immed life-threatening;
Patient slumped over in her chair shortly following administration of the HPV vaccine. She was A&Ox2 and did not know where she was. She was transferred from the immunization room to the treatment room and placed supine with her lower extremities slightly elevated and a blanket placed over her. Vitals taken shortly after event and reassessed 10 minutes afterwards. Results forwarded to NP on site and patient was shortly met with and released by NP.