chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to the ED on 5/1 with 3-4 day history of fever and rash. Rash was worsening and fever not resolving with antipyretics. He additional had congestion x 2weeks s/p T&A on 4/15 and decreased PO with subsequent decreased UOP. He was dehydrated requiring IVF. Rash consistent with primary varicella. There are no known contacts with similar symptoms. Patient is NOT in daycare. Blood PCR for varicella sent. There were no intact blisters available to perform tzank smear. He improved with one night IVF and was d/c home to continue supportive care.
pt exp fever 101 5JUN98;6JUN98 fever 102-103;7JUN98 fever 104.5 7PM to hosp ER stayed 5-6hr-motrin, APAP suppository;supportive-fever;T100.8 8JUN98 now;
Fever up to 103º, lethargic, heart rate 120, SpO2 97%.
Information has been received from a nurse concerning a 20 year old female with eczema who on 15-MAY-2008 was vaccinated with her first dose of GARDASIL (lot# not reported).  There was no concomitant medication.  On 15-MAY-2008, 4 hours after vaccination, the patient experienced hives all over her neck and arm.  The patient sought medical attention in the office on 19-MAY-2008 and the hives were all over her body.  The patient's hives persisted.  Additional information has been requested.
Death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: Patient had it for about a year or two. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose), administration date: 08Feb2022, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: DEATH (death) with onset 24Apr2022, outcome "fatal". The patient date of death was 24Apr2022. The reported cause of death was unknown. No autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201322762 Same reporter/ drug/ AE, different patients;; Reported Cause(s) of Death: Death
Started screaming in pain and inconsolable. By that evening (8:30) he started pooping blood. He had a 101.2 temp.  I called ER and was told not to worry unless he is still pooping blood in AM. The next morning it continued and brought him in. They did blood work, ultrasound twice and X-ray. Then admitted him to hospital. Put him on a 24 Hr Pedialyte diet and sent us home the following day. Two days later the blood was back. Went back to ER. He received IV of fluids to help his dehydration from diarrhea and did more blood work and then sent us home. This was yesterday and he is still battling diarrhea.
About one week after getting the vaccine, I noticed my lower legs were tingling and numb in spots. Over the course of a year, it spread to my upper thighs and torso. Throughout this, my arms also had tingling and a burning sensation. WHenever clothing or blankets are touching my skin, it has a burning sensation, This has not resolved nor has it lightened up.
shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.The outcome of the event shingles was not recovered. The lawyer considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).
Red itchy eyes, red swollen eyelids, puffy face, high blood pressure, chest pain, dry, blotchy, itchy skin on face.  Cold sore in mouth that developed overnight.  Symptoms started to subside after 48 hours.
FATIGUE, FEVER, CHILLS, COUGH, MALAISE FOR 3 DAYS AT TIME OF PRESENTATION TO HOSPITAL (1/1/22)
16DEC91 grandma gave asprin because felt warm didn't take temp; 17DEC t102 ax gave APAP & took pt to MD; temp in office 99;
cough; hard to breath; Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a 78-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: cough), difficulty breathing (Verbatim: hard to breath) and fever (Verbatim: Fever).  The outcome of the cough, difficulty breathing and fever were resolved (duration 3 days).   It was unknown if the reporter considered the cough, difficulty breathing and fever to be related to RSV vaccine.     It was unknown if the company considered the cough, difficulty breathing and fever to be related to RSV vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 and 18-SEP-2023 This case was reported the patient via interactive digital media. The patient got an RSV shot by the physician and got severe side effects cough, hard to breath, fever about 3 days.
COVID arm; Arm of injection is warm to touch; A rash appeared at the site of injection. The rash is red and a little itchy.; A rash appeared at the site of injection. The rash is red and a little itchy.; A rash appeared at the site of injection. The rash is red and a little itchy.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Arm of injection is warm to touch), VACCINATION SITE PRURITUS (A rash appeared at the site of injection. The rash is red and a little itchy.), VACCINATION SITE RASH (A rash appeared at the site of injection. The rash is red and a little itchy.) and VACCINATION SITE ERYTHEMA (A rash appeared at the site of injection. The rash is red and a little itchy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No medical history was reported.     On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Arm of injection is warm to touch), VACCINATION SITE PRURITUS (A rash appeared at the site of injection. The rash is red and a little itchy.), VACCINATION SITE RASH (A rash appeared at the site of injection. The rash is red and a little itchy.) and VACCINATION SITE ERYTHEMA (A rash appeared at the site of injection. The rash is red and a little itchy.). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) on 24-Aug-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Arm of injection is warm to touch) and VACCINATION SITE RASH (A rash appeared at the site of injection. The rash is red and a little itchy.) outcome was unknown and VACCINATION SITE PRURITUS (A rash appeared at the site of injection. The rash is red and a little itchy.) and VACCINATION SITE ERYTHEMA (A rash appeared at the site of injection. The rash is red and a little itchy.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.
This spontaneous report as received from 2 healthcare workers refers to numerous unspecified patients. No demographic information was provided. RECOMBIVAX HB (lot number not provided) was exposed to 29-35 degrees Fahrenheit multiple times over a period of 3 months. The improper storage started on 29-DEC-2012. The improperly stored RECOMBIVAX HB was administered to numerous unspecified patients on unspecified dates. Reportedly RECOMBIVAX HB was "not supported by in-house stability data". No adverse event reported. This is one of several reports received from the same source (other case IDs 1306USA008658, 1307USA008944, 1307USA008945, 1307USA008947, 1307USA008948 and 1307USA008949). Additional information has been requested.
A FEW WEEKS AFTER RECEIVING THE 2ND PFIEZER VACCINE, I STARTED HAVING CHRONIC BODY PAIN DAILY, EXTREME PAIN, MIGRAINES.  I AM NOW IN CONSTANT CHRONIC PAIN AND DIAGNOSED WITH FIRBROMYALGIA.  I DID NOT HAVE THIS PAIN PRIOR TO RECEIVING THE COVID VACCINE MY PAIN IS NOT IMPROVING AS TIME GOES BY, IT IS WORSENING.  THIS IS SOMETHING THAT WILL IMPACT ME FOR THE REST OF MY LIFE.
Information has been received from a physician concerning a 14 month old consumer who on 06-FEB-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The physician stated this was staff error and not product confusion. No adverse experience is related to this event. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician indicated that it was totally staff error. They are a general family practice and have both pediatric and adult vaccines in storage. Because these vaccines are both stored at the same temperature, the wrong vaccine was obtained and administered. Because of the incident, they have instituted a new policy, that all physicians' must check the labels on the vials before the nurses administer the medication. They are planning on using bright fluorescent labels on the medicine labeled for adult and pediatric. Additional information has been requested.
I was positive for COVID-19 on 27FEB2023, I was coughing, then I was congested and around March, I started to have a fever. I had muscle soreness and aches, none was severe besides the cough. I started to take PAXLOVID once I contacted my doctor, I started feeling better about few days after started taking the medication.
Achy for 24 hours, onset of headache 48 hours after 2nd dose
Site: Pain at Injection Site-Mild, Systemic: vaccine leaked out of syringe tip not tightened well redid vaccine pt got poked twice 1 with vaccine 1 without leaked all out-Mild, Error: Wrong Route (SC, IM, etc.)-
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Medium
1 week later developed Shingles; This is a spontaneous report from a Pfizer sponsored program for contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid vaccine and 1 week later developed Shingles. Patient wanted to know can she take the Shingles vaccine before receiving the second dose of the Pfizer Covid vaccine, which should had been received on 20Jun. The clinical outcome of the events was unknown.  Information about batch/ lot number has been requested.
There was an allergic reaction that caused itchiness all over the body as well as facial swelling.
Patient presented on 7 February 2018 stating she just came from the physician's office with a rash on her arm where she received two shots (PREVNAR 13 and FLUZONE QUAD). Prescriber gave her a steroid ointment and she was satisfied with this. I asked if the physician's office call cost her anything - she said it did not. I refunded the cost of the ointment to her.
Patient presented to ED on 10/11/21 with 3 days fo productive cough without dyspnea. Patient is fully vaccinated. She was appropriately treated and was discharged on 10/22/21.
pt admitted to hosp after 3 days of fever, cough, SOB; positive for COVID 19; hypoxic respiratory failure; septic shock - treated with Levophed; acute encephalopathy; remained in coma; exacerbated episode of COPD; placed on ventilator 100% FiO2; multiorgan system failure; pt was made a DNR and comfort measures; extubated and pt died at the hospital
Pt observed for 15 minutes per recommendations, left with no concern and returned 5 minutes after with Hives located on the upper chest. Notified task force of event and immediately advised to report to ER for continuation of care.
He developed arrythmia and his "heart will act up"; he has had "gastrointestinal issues" and "difficulties with using the bathroom."; he has had "a lot of suffering"; The effects have "taken a toll on his mental health" and resulted in "neurological conditions."; This spontaneous report has been received from a consumer referring a 23-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date, reported as "sometime 2017- 2018", the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for human papilloma virus prevention (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided).  On an unknown date, the patient experienced a lot of health issues. It was reported he developed arrhythmia and his "heart will act up" (arrhythmia). He has had gastrointestinal issues (gastrointestinal disorder) and difficulties with using the bathroom. Also, he has had a lot of suffering (emotional distress), where the effects have taken a toll on his mental health and resulted in neurological conditions (nervous system disorder). The outcome of the aforementioned events were not reported.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event arrhytmia was determined to be medically significant.
Advanced cataracts; dose 1 02Aug2021/dose 2 on 16Aug2021 13:00; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Aug2021 13:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No COVID prior to vaccination and not tested post vaccination. Patient have no known allergies. The patient took blood pressure medicine. Patient have no vaccine in four weeks. Vaccination history included: Bnt162b2 (dose 1, 13:00), administration date: 02Aug2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: CATARACT (disability) with onset 15Sep2021 12:00, outcome "not recovered", described as "Advanced cataracts"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Aug2021 13:00, outcome "unknown", described as "dose 1 02Aug2021/dose 2 on 16Aug2021 13:00". The event "advanced cataracts" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of cataract.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 40 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported, Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
On Day 8 after the 1st shot my injection sight became warm, red and itchy. I also became itchy on my ankles. A raised rash developed on my ankles and spread to my legs and arms and is extremely itchy. I have treated this allergic reaction with Benedryl. The rash is still present on day 10.
09/08/21 Mild skin irritation, 09/09/2021 Skin irritation and a handful of red, itchy bumps, 09/10/2021 skin irritation and hundreds of red, itchy bumps covering back and torso, started to appear on the front of my torso, 09/11/2021 skin irritation, hundreds of red, itchy bumps covering back and torso, extended to neck and down to feet.  Attempted to go to clinic but could not get an appointment, tried to go to Emergency Room but the line was long and into the parking lot.
I felt a couple of strong rushes around my heart and it countinued for the next 3 days with it getting less strong each day. And then it happened periodically after that and it is still continuing today. I went to the emergency room due to it escalating on April 12, 2012 and was admitted overnight to check heart.
Started w/paresthesia in arms a few hrs p/inject; Progressed to generalized weakness; adm to hosp to neuro intensive care w/partial paralysis of all extremities; never required resp assistance; plasmaphorisis done;
11 am started noticing tingling in Right side of face. Then redness on ry neck below jaw and  tingling on left side of face and left side of body. Lasting for 1 hour
11/2/21 pt had a positive COVID test; 11/7/21 pt to ED with AMS and in respiratory distress requiring intubation with mechanical ventilation upon arrival; positive COVID test; developed worsening shock; transferred to ICU; pt expired in the hospital
Information has been received from an investigator and medical records as part of a study concerning a 72-year-old, widowed male with type 2 diabetes mellitus and a 10 year history of coronary artery disease. The patient had additional medical history of a prior myocardial infarction (1998), obesity (per measurement at patient's last medical visit weight was in "normal weight" range (ht 6'3", wt 199) as recently as 2005 weight was 306), hypertension, hyperlipidaemia, chronic mechanical low back pain (2006), surgery for herniated disc (2006), peripheral edema (August 2007), angina (August 2007). On 23-OCT-2007 the patient had routine lab work done. Based on results, patient's physician sent a letter indicating "both your diabetes and cholesterol are poorly controlled" and the physician requested an appointment. This appointment was the patient's last medical visit and day of vaccination (29-OCT-2007). According to the medical records the patient was diagnosed with hyperlipidaemia, type 2 diabetes and coronary artery disease. On 29-OCT-2007 the patient was vaccinated subcutaneously into the left arm with a first dose of ZOSTAVAX (Merck) (lot# 658209/1085U). Concomitant therapy given on the same date included the dose number twelve of FLUVIRIN (lot # 79898), given intramuscularly into the right deltoid. The patient expired suddenly on 10-DEC-2007, according to the coroner's report the immediate cause of death was cardiopulmonary arrest with secondary cause of 10 year history of Coronary Artery Disease. Diabetes Mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done. During the last medical visit, on 29-OCT-2007, the patient's physical examination was within normal limits; his blood pressure was 94/50, his pulse was 71 and temperature 97.6 degrees F. The patient started therapy with metformin 500 mg oral bid, famotidine (manufacturer unknown) 40 mg oral bid, metoprolol tartrate 100 mg bid, glipizide, 10 mg bid, captopril 100 mg TID, lovastatin 40 mg daily and furosemide 40 mg daily. The patient was also on therapy with simvastatin (MSD) 40 mg on 29-OCT-2007. The patient had a LDL was 159 and the Hga1c was 7.8%. At that time the patient was discharged with the following instructions: take 4 units NPH insulin in the morning, aim for a blood sugar of 140 or less before meals; stop lovastatin start simvastatin (MSD), check a 12 hr fasting blood test after 6 weeks of taking simvastatin (MSD), check a fasting blood test for diabetes/cholesterol. At this time, relationship of cardiopulmonary arrest to study therapy is unknown. A lot check has been initiated. Additional information is expected. All available medical records will be provided upon request.
Feels like he got dragged; Vomiting; Fever of 101.5 degrees F; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Feels like he got dragged), VOMITING (Vomiting), PYREXIA (Fever of 101.5 degrees F), PAIN (Aches) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Feels like he got dragged), VOMITING (Vomiting), PYREXIA (Fever of 101.5 degrees F), PAIN (Aches) and CHILLS (Chills). At the time of the report, GAIT DISTURBANCE (Feels like he got dragged), VOMITING (Vomiting), PYREXIA (Fever of 101.5 degrees F), PAIN (Aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 101.5 (High) Fever of 101.5 degrees F.         No concomitant medications were mentioned. No treatment details were reported.
Cellulitis developed at injection site within 24 hours. Responded well to KEFLEX 500 gram PO for 10 days.