chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 70 year old patient. Medical history and concurrent conditions were not reported. On 04-FEB-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
vaccines that were administered to patients after excursion occurred; This spontaneous report as received from a nursing assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.      On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number: T002846, expiration date: 23-JAN-2022, dose and route of administration were not provided). The vaccine was stored in temperature -10.2 degree Celsius for 1 hour and 53 minutes. There was no previous temperature excursion. Digital data lodger was involved.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014798: US-009507513-2008USA014951: US-009507513-2008USA014697: US-009507513-2008USA014705: US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014803: US-009507513-2008USA014806: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014888: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117:
Immediate sore arm/swelling.  Nausea and headache in 2-3 hours.  Fever, diarrhea, abdominal pain in 4-5 hours.  Symptoms escalated - extreme chills/tremors and severe abdominal pain, nausea, diarrhea, headache in approximately 20 hours from injection.  Severe symptoms subsided to moderate, with fatigue, after approximately 24 more hours.  Following 24 hours was tolerable, although not able to eat without discomfort.  Severe symptoms began returning at roughly the 72 point following injection and escalated rapidly.  Collapsed in 60-90 minutes with excrutiating abdominal pain, fever, chills, extreme weakness.  Rushed to hospital by squad, underwent emergency surgery for perforated bowel/internal bleeding in jejunum.  Removed 50cm of jejunum, infused platelets.  Developed pneumonia and UTI toward end of several days in hospital.  Went home on Levaquin 750mg.  Three weeks postop, it was determined that I had an infection in GI tract - took another week of Levaquin.  8 weeks postop, gynecologist noted pelvic inflammation with no apparent root cause.  August 30, went to emergency room with fever and low abdominal pain.  CT scan showed a new perforation of sigmoid colon with adjacent abdominal abscess.  Abdominal inflammation was too extreme to perform surgery at that time as tissues were too inflamed to hold up to any repair.  Three antibiotics, NPO for days, then clear liquids, finally tolerated some soft foods.  Went home on two antibiotics for another week.  Currently, abscess is reduced to half size, inflammation is diminished roughly 50%.  Continued dietary modifications and continued low grade fever.
9 mm in Diameter red swollen  on left upper arm said to be itchy  seen 5/20/19
Nausea followed by vomiting - child threw up 4 times between 3:00-8:00 AM.
Approx 10 minutes after vaccination, pt felt transient diffuse itching that resolved after a 2 minutes.  No skin eruptions.  After another 10 min, pts upper lip began to swell.  VSS and airway remained intact.   EMS activated.    Pt given 50mg IM benadryl.    EMS gave IV solumedrol during transport to ED.   In ED given 20mg PO famotidine and observed for 2 additional hours.  Discharged with Prednisone 40mg PO daily, PO Famotidine 40mg daily and diphenhydramine 25mg PRN.
Extreme fatigue, impaired cognition, headache, dizziness, light sensitivity, fever, chills, body/aches/pains. Slight confusion.
shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2014, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a physician at a her office, and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would 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 was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt recvd 3 Engerix-B doses in DEC90, JAN91, & MAY91 & pt did not seroconvert following the 3rd Engerix-B dose titer was drawn NOV91;
Initially Experienced Vasovagal syncope 6 hours after vaccination along with Hot flash and extreme weakness Severe abdominal cramps followed about 3 hours later with bowel movements turning into diarrhea.
tireness, no appetite, finds it difficult to converse These symptoms have gradually gotten worse since the second vaccination. She has been to ER and Prompt care.
Patient was given 2.5ml of Moderna for a booster shot.  Dose should have been 0.25ml.  The following day the patient reported headache, slight fever, fatigue and uneasy stomach.
Headache beginning 24hours after injection lasting 1 week.   Drooping of left eyelid beginning 11 hours after injection still continues after 10 days.   Intermittent blurred vision in left eye still continues after 10 days.
I felt sluggish after my second Moderna shot on April 15th.   On the evening of April 27th, I really started to feel horrible and was scared as it was hard to breathe and my chest pains were just horrible.   I head to ER and am told I have blood clots in both lungs and 2 blood clots in lower leg.   Taken by ambulance to the hospital.
Monday June 6th I started having a scratchy throat in the morning. That night it began to hurt. Tuesday it was really hurting and I began to get a cough and I began running a fever up to 105. I had a horrible sore throat and a terrible cough. I sounded like sea lions arguing, honking like sound, non stop. I stayed in bed the whole time. By Wednesday afternoon, I was just coughing non-stop and I was getting dizzy and my head was hurting due to the coughing. The top part of my chest was very sore. I called the insurance hotline. I was advised to go to the ER. They prescribed a steroid and an inhaler with Albuterol and some cough medicine. I would be scheduled for the infusion.  I went to on Friday for the infusion.  I felt horrible until Sunday.  I had the cough for another week after that pretty consistent.  Then it got to where I would try to talk to someone or lay down to go to bed.  I have been feeling better for a week and a half.
no adverse event, It keeps reoccurring in one spot after vaccinated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: no adverse event, It keeps reoccurring in one spot after vaccinated). The outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported via consumer interactive digital media. The reporter said that's why you had nerve pain. The reporter had heard this from 3 persons, one was his/ her friend. It keeps recurring in one spot after vaccination. The reporter had it because of medication side effects and never got it since.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057502:Same reporter US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057506:Same reporter US-GSK-US2023AMR057506:Same reporter
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 23-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was kind of nervous before receiving the vaccine. He felt lightheaded while waiting his 15 minutes after receiving the vaccine. He began to feel nauseous and then vomited once. Blood pressure was 106/61, heart rate was 87, O2 was 99. Patient was cooled with an ice pack and give water to sip. After 30 minutes he began to cool down and the nausea went away. He was also given 1 25 mg tablet of diphenhydramine.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: PT REPORTED HAVING MILD DIZZINESS AFTER 15 MINUTES OF OBSERVATION. RPH HAD PT LIE DOWN WITH ELEVATED LEGS. DURING OBSERVATION, PT WAS QUITE RESPONSIVE, PT STATED HE'S FEELING BETTER AND CHOSE TO LEAVE AT 3:52PM. RPH CALLED PT AT 6:46PM, PT REPORTED HE'S WELL AND DOESN'T FEEL DIZZY ANYMORE.
Large hives and rash developed around left armpit stretching over ribcage. His belly button also had a bright red pimply rash. His ears turned bright red and warm. Additional large hives randomly on his arms and legs. The leg when the injection also had large rash around. He also was quite lethargic, we thought it was due to exhaustion, but he slept for several hours more than normal. With Benadryl, most has gone down, 24 hours later, his hives are much improved, but the injected leg remains swollen, covered in a rash and warm. He is still a bit "off" and sleeps more than usual, even without the Benadryl.
7x8 cm area red, warm, tender lesion surrounding vaccine site. Center of lesion is indurated and redened.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized muscle aches in a 62-year-old male patient who received SHINGRIX. The patient's past medical history included shoulder injury. On 15th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th April 2018, 1 days after receiving SHINGRIX, the patient experienced generalized muscle aches, shoulder injury and condition aggravated. On an unknown date, the outcome of the generalized muscle aches, shoulder injury and condition aggravated were not recovered/not resolved. The reporter considered the generalized muscle aches, shoulder injury and condition aggravated to be probably related to SHINGRIX. Additional details were reported as follows: The pharmacist reported the case on behalf of the patient. The patient received SHINGRIX on left deltoid. The patient experienced generalized muscle pain in the large muscle groups such as legs, shoulders, and hips. The muscle pain had aggravated his previous injury. The pharmacist stated that this had been reported also to VAERS and that the patient was planning to visit his healthcare professional for this event.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as multiple unspecified patients received improperly stored GARDASIL 9. The temperature was 47.98 F and the time frame was 63 hours. No adverse event was reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
INJECTION SITE OEDEMA; INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION  Information has been received from a physician concerning an approximately 4-month-old patient who on unspecified dates was vaccinated with two 0.5 mL doses of measles virus vaccine live (Enders-Edmonston 9+) mumps virus live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck update process). Subsequently, the patient experienced swelling at the injection site after the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine liver (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Unspecified medical attention was sought.  The patient recovered on an unspecified date. No product quality complaint was involved.  Additional information has been requested.
COVID?19 Vaccine EUA; Injection site is swollen, hard, very hot to the touch and a red rash that is ~3in in diameter. Slightly itchy but tolerable.
Reddened area right upper arm burning pain no itching induration and 9 x 4 cm redness
Over a 3 week period patient lost 20 pounds, extremely tired, & dehydrated. On 3-26-07 she was diagnosed with Type 1 Diabetes and Hypothyroid. She was admitted with a 1075 blood sugar. No family history of Diabetes.
PT started to have tingling in her mouth, felt like her tongue was swelling, nausea and dry hiving, hands cramping, elevated heart rete and  blood pressure. PT had taken 50 mg Benadryl 30 minute before vaccination per her PCP. Provider evaluated PT, PT was observed on site for approximately an hour before her symptoms stated to subside. PT was driving home by spouse.
Patient was a CODE BLUE on 7/19 - poorly responsive, marginal respiratory efforts, trivial pericardial effusion, RV had some fair contractility. Per doctors note on 7/19 at 1933 "Doctor called. HEENT discovered that the patient had the moderna Covid vaccine on 6/22/2021. This was the patient's first dose. He raises the possibility of myocarditis related to the vaccine. This is a rare but potentially serious complication that has been reported. Treatments that have been tried include nonsteroidal anti-inflammatory drugs, IVIG and steroids. Some of the mild cases have resolved within a few days to a week.Given the clear lack of an explanation for his myocardial dysfunction, the severity of his illness and the proximity to receiving the moderna vaccine, we will institute all 3 of these interventions tonight."
Developed intense headache, muscle pain, and nausea at 12:30 am, 3/11/21.  Still have Headache, muscle pain, nausea, and fatigue as of March 12, 2021.  Took over the counter Aleve, Tylenol, Ibuprofen , and PeptoBismol  to relieve symptoms.  Please note:  My doctors say I had Covid 19,  in early March 2020.  Had viral pneumonia and 8 out of 10 covid symptoms for several weeks.
Information has been received from a healthcare worker concerning a 76 year old female who on 22-MAR-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U). On 30-MAR-2007 the patient experienced shingles on her back. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was available. The patient's shingles were considered disabling. Additional information has been requested.
high-pitched screaming. Periods of being inconsolable for 1 wk. -Started 4 hours after shot.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 03-JUN-2016, the patient was inadvertently vaccinated with improperly stored GARDASIL 9 injection lot # L020015 with expiry date 16-AUG-2017 or lot # reported as L006546 with expiry date 27-NOV-2017 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for further contact.
vaccine brand other: Covishield; vaccine brand other: Covishield; Treatment of COVID-19; Treatment of COVID-19; Rebound symptoms with repeat positive COVID test after testing negative previously; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVISHIELD), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latent TB" (unspecified if ongoing), notes: Other medical history= Latent TB; "leukocytoclastic vasculitis" (unspecified if ongoing), notes: Other medical history= leukocytoclastic vasculitis; "Lupus anticoagulant with prior clot" (unspecified if ongoing), notes: Other medical history= Lupus anticoagulant with prior clot. Concomitant medication(s) included: AZATHIOPRINE, start date: 04May2022, stop date: 04Aug2022; ISONIAZID; WARFARIN; PYRIDOXINE. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 13Aug2022, outcome "recovered" (14Aug2022), described as "Rebound symptoms with repeat positive COVID test after testing negative previously"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "vaccine brand other: Covishield"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative previously; Positive, notes: Rebound symptoms with repeat positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported disease recurrence described as "rebound symptoms with repeat positive COVID test after testing negative previously" was considered as drug ineffective of vaccine BNT162B2, which was likely associated with off label use and interchange of vaccine products.
Info has been received from a physician concerning a pt who was vaccinated with a dose of MMR (+) varicella virus. Subsequently, the pt developed a fever greater that 101. Additional info has been requested.
A diagnosis of MS was established; right sided internuclear ophthalmoplegia; left hand paresthesia; urinary urgency; gait imbalance; isolated left arm hyperreflexia; This is a literature report for the following literature source(s): "New diagnosis of multiple sclerosis in the setting of mRNA COVID-19 vaccine exposure". A 37 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "A diagnosis of MS was established"; OPHTHALMOPLEGIA (medically significant), outcome "unknown", described as "right sided internuclear ophthalmoplegia"; PARAESTHESIA (non-serious), outcome "unknown", described as "left hand paresthesia"; MICTURITION URGENCY (non-serious), outcome "unknown", described as "urinary urgency"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "gait imbalance"; HYPERREFLEXIA (non-serious), outcome "unknown", described as "isolated left arm hyperreflexia". The patient underwent the following laboratory tests and procedures: anti-aquaporin-4 antibody: negative; investigation: notable for right sided internuclear, notes: ophthalmoplegia and isolated left arm hyperreflexia (3+); negative; negative; magnetic resonance imaging head: multiple periventricular nonenhancing t2/flair, notes: hyperintensities and a C3-C4 cord T2 and STIR hyperintense lesion, compatible with demyelination; magnetic resonance imaging neck: multiple periventricular nonenhancing t2/flair, notes: hyperintensities and a C3-C4 cord T2 and STIR hyperintense lesion, compatible with demyelination. Therapeutic measures were taken as a result of multiple sclerosis, paraesthesia, micturition urgency, gait disturbance, hyperreflexia.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Multiple Sclerosis, Ophthalmoplegia, Paraesthesia, Micturition urgency, gait disturbance, hyperreflexia  and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200012186 Same article/drug/event and different patient