chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of drug administration; no adverse effect Information has been received from a physician concerning patients who were vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) outside of the indicated age range. It was unknown if medical attention was sought and no complications were reported. No further information is available.
headache 30 mins after shot -- started feeling bad--- like a cold that evening --getting a little worse every day-- body aches, very runny nose, low grade headache, feeling warm but not really fever, today getting heavier congestion and using my abuteral  at least 4 times a day since yesterday evening - heavy coughing with no spewtum results
Lymph nodes swollen left side arm and underneath arm Inflamed left hand joints Leg pain more severe in the right side  with itchiness / sensation of bugs crawling in my legs.
per death certificate pt died at home with COVID 19 listed as a condition contributing to death; pt was in hospice ( Medical Center - Hospice) pt had a positive COVID test recorded on 8/23/21; ordering facility (Privacy).
After about 30 minutes experienced a warm flushing feeling and shortness of breath.  Lasted about 8-10 minutes and then started to subside.  Pulse oximetry 99%, HR  72,  BP  144/84,  RR 20.  States she has had anxiety reactions to vaccines in the past.  Monitored for an extra 30 minutes.  Refused Benedryl or Epinephrine.  Refused  a visit to emergency room.  Advised when leaving if symptoms increase to search out medical care. States she feels back to her normal self upon leaving.
Herpes zoster diagnosis in a man previously vaccinated with zoster vaccine. diagnosed by, MD. Treated with PO acyclovir x11 days. Onset date 11/18/2016. Rash lasted less than 2 weeks. Rash on right face with eye involvement. Onset of bell's palsy on 1/1/2017.
Bones and muscles seemed to ache; fatigue. Slight nausea. About 4pm I got cold and started shaking; shaking involved whole body and teeth-chattering even after setting room temp high. Talked to doctor's office who suggested emergency room visit. Took a Benadryl and went to emergency room but did not check in. Shaking stopped about 45 minutes after Benadryl. Returned home. Extreme fatigue for next 24 hours. Low-grade temp for about 36 hours. Occasional stomach ache and head ache. Sore muscles. A few short-lived hives on arms and legs about 24 hrs after shot. Back to normal after 44 hours.
Received second injection of vaccine and drove back (2 hours) to. After approximately 6-10 hours I experienced fever, headache, and pain in right eye spreading left eye as well. These effects (fever, headache) were anticipated and I basically lay in bed, drank water, took an Excederin. The fever and headache subsided after 24 hours or so. However, after recovery I noticed numerous additional small 'floaters? in both eyes.  ?Floaters? are fixed location defects in the vitreous humor.  As an optical physicist, 'floaters' are somewhat interesting and I had discussed the 3 floaters I had (prior to the vaccination) with Dr.  (Prior optometrist).  Dr has high resolution photographs of my retina on file, however, apparently these do show show the 'floaters' found in the vitreous humor.  Prior to second vaccination shot I only had 2 floaters in right eye and 1 in left eye.  After the second vaccination I noticed numerous, smaller floaters (approximately 80-90) in central vision of both eyes. These smaller, new ?floaters? are distributed somewhat uniformly.  Again, both eyes have approximately same distribution and size.  The size of the new 'floaters' is substantially smaller (10x) than that of the original 3 floaters. The floater ?size?  is best described in terms of ?solid angle?, measured in steradians.  The original three floaters subtend approximately 47e-06 sr (sr is steradian, or 47 microsteradians).  The new smaller floaters subtend approximately 5e-06 sr (5 microsteradians, approximately 1/10 of the original larger floaters).  Number density (new floaters per sr) is approximately 80-90 per 7e-03 sr (7 milisteradians) and appears to be spaced uniformly across (both) eyes. Due to the ongoing outbreak I did not seek additional medical attention, as the 'floaters' are only noticeable under certain lighting conditions (well-lit sky or backlit white screen (ppt show for example) or backlit  TV with a white display present).  On a recent trip to I attempted to contact Dr. but found that she may have retired.  (She was previously at
REALLY SICK FOR 2 WEEKS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, lupus, gastrooesophageal reflux disease, heartburn, polycystic ovarian syndrome, migraine headaches, nausea, allergies, dry eyes, off balance, thyroid nodules, pain, and multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included azelastine, bupropion hydrochloride/naltrexone hydrochloride, cannabidiol, cetirizine hydrochloride, cimetidine, diphenhydramine hydrochloride, erenumab, lisinopril, methylprednisolone sodium succinate, montelukast sodium, ocrelizumab, omeprazole, ondansetron, steroids, and.  On an unspecified date, the patient experienced really sick for 2 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really sick for 2 weeks was not reported. This report was non-serious.
Shot given 3 pm on 12/16/09, Around 2am started with vomiting, diarrhea and cramping. Also developed some slurred speech and weakness of extremities. Slurred speech and weakness lasted 3 hrs. Continued with vomiting and diarrhea throughout 12/17/09. Doing well now.
Patient started to get dizzy, lightheaded and was sweating. Patient became cold and teeth were chattering.
8/30/00 @ 12:00 temperature approximately 104 F with complaint of disorientation, shaking with these symptoms 8/31/2000 temperature 102 F 09/01/2000 temperature returned to normal and symptoms subsided.
improper preparation of thawed vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (improper preparation of thawed vial) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (improper preparation of thawed vial). At the time of the report, PRODUCT STORAGE ERROR (improper preparation of thawed vial) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Moderna COVID-19 Vaccine EUA:  patient presented to emergency department (ED) with altered mental status and weakness with positive COVID test and acute kidney injury in setting of chronic kidney disease and poor oral intake. No evidence of pneumonia. Volume status corrected, received remdesivir, and medications adjusted  resulting in improved mental status and renal function. Patient discharged to home medically stable.
DEATH; SEIZURES; This spontaneous report received from a consumer via a company representative via social media (twitter) concerned a male of an unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient developed seizure and then died. As per the reporter, "I know an hour after taking the vaccine this 100 percent healthy kid had seizures. Next thing the patient was dead." It was unknown if an autopsy was performed or not. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of seizures was not reported. This report was serious (Death).; Sender's Comments: V0: 20210855833-covid-19 vaccine ad26.cov2.s -Death, Seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report as received from a physician refers to a 68 year old male patient with diabetes mellitus, hypertension, high cholesterol and chronic kidney disease stage III and no known drug allergies. The patient's medical history included herpes zoster on an unspecified date. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J001008, expiration date 24-APR-2014) 0.65 ml subcutaneous in the left arm. Concomitant therapies included COZAAR, JANUVIA, AMARYL, LIPITOR, and NORVASC. The physician reported that patient received ZOSTAVAX and developed a rash the next day (on 23-JUL-2013). Physician stated that patient called the office on 23-JUL-2013 and 25-JUL-2013  because he thought he was having an allergic rash and the physician recommended a steroid cream. Patient stated that steroid cream was ineffective and was seen in the office on 27-JUL-2013. He was diagnosed with herpes zoster and was prescribed VALTREX and pain medications. The lesions were in torso, scalp and between legs. Physician reported that patient was seen in the office on 29-JUL-2013 and that the shingles rash was spreading. A sample from a lesion on the skin was taken on 31-JUL-2013. Patient denied recent exposure to chickenpox or shingles. At the time of the report the patients outcome was reported as not yet recovered. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (localized induration, itchy on the injection site), INDURATION (localized induration, itchy on the injection site) and EYE PRURITUS (red, itchy eyes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis and Cataract operation.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PRURITUS (localized induration, itchy on the injection site) and INDURATION (localized induration, itchy on the injection site). In February 2021, the patient experienced EYE PRURITUS (red, itchy eyes). In February 2021, EYE PRURITUS (red, itchy eyes) had resolved. At the time of the report, INJECTION SITE PRURITUS (localized induration, itchy on the injection site) and INDURATION (localized induration, itchy on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included steroid eye drops. No concomitant medications reported.
Pt LMP 4-23-18 was given varicella vaccine 5-4-2018. (positive) Preg test 6-4-2018.
Employee received Pfizer Covid vaccine booster on 10/1/2021 @ 1510 @ Hospitals. After booster was administered, employee was monitored for 15 minutes at the vaccination clinic for any adverse/side effects  and no adverse/side effects were noted or reported. Then, employee walked back to her department. Shortly after, she began having headache, drooling and slurred speech. At approximately 1600, employee was transported from hospital location to another location.  Health and Safety Officer contacted Emergency Department @ 1710 and was informed that the employee was still there receiving treatment and being monitored.   As of 10/4/2021, per Health and Safety Officer employee is still in medical facility.
No further AE details; PROQUAD was stored in the refrigerator instead of thee freezer; PROQUAD administered concomitantly with VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.       It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer since 01-DEC-2020.   On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Product storage error) (dose number, strength, anatomical location and route of administration were not reported, lot # T025221, expiration date 19-JAN-2022, therapy type: recombinant Human albumin (rHA)) at a dose of 0.5 milliliter for prophylaxis, administered concomitantly with a properly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose number strength, anatomical location, route of administration, lot # and expiration date were not reported) at a dose of 0.5 milliliter for prophylaxis (Inappropriate schedule of product administration).  It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine was exposed to a temperature of 44 Fahrenheit (F) for a time frame of 1506 hours. There was no previous temperature excursion and the call was not due to a data logger. No further adverse event (AE) details were provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2102USA001266: US-009507513-2102USA001044: US-009507513-2102USA000941: US-009507513-2102USA001248: US-009507513-2102USA001301:
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JAN-2016, the patient was vaccinated with improperly stored Oral, ROTATEQ. This is one of the several reports received from the same reporter. Additional information has been requested.
Narrative:  87yo patient who receives MEDICAL care & pharmacy meds outside facility died on 7/21/21. PROBLEM : Dementia (SCT 52448006) (ICD-10-CM F02.80) 04/29/2021 H/O: rheumatoid arthritis (SCT 161567008) 04/29/2020 (ICD-10-CM M06.9) Automatic implantable cardiac defibrillator in 04/15/2019 situ (SCT 443325000) (ICD-10-CM Z45.02) Coronary arteriosclerosis (SCT 53741008) 03/29/2017 (ICD-10-CM I25.10) (ICD-9-CM 302.72); Male erectile disorder 03/14/2011 (ICD-9-CM 302.72/607.84) (ICD-9-CM 714.0); Arthritis, Rheumatoid * 03/14/2011 (ICD-9-CM 714.0) (ICD-9-CM 414.9); CAD * (ICD-9-CM 414.9) 07/02/2008 (ICD-9-CM V65.9); Health Maintenance (ICD-9-CM 11/07/2006 V65.9) (ICD-9-CM 562.10); Diverticulosis * (ICD-9-CM 11/07/2006 562.10) (ICD-9-CM 530.81); Gastroesophageal Reflux 06/26/2003 Disorder * (ICD-9-CM 530.81) (ICD-9-CM 272.4); Hyperlipidemia * (ICD-9-CM 06/26/2003 272.4) (ICD-9-CM 272.4); Hyperlipidemia * (ICD-9-CM 06/26/2003 272.4) (ICD-9-CM 272.4) (ICD-9-DM 250.00); Diabetes Mellitus Type II or 06/26/2003 unspecified * (ICD-9-CM 250.00) (ICD-9-CM 272.4); Hyperlipidemia * (ICD-9-CM 02/01/2003 272.4) Arteriosclerotic Cardiovascular Disease 04/04/1996 (ICD-9-CM 429.2), Onset 00/00/1995 Essential Hypertension (ICD-9-CM 401.9), Onset 04/04/1996 00/00/1995 Nosie effects on inner ear (ICD-9-CM 388.10), 04/04/1996 Onset 00/00/1996 Pt had received covid vaccines from outside provider.This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
I test pretty regularly for COVID-19 and I had an upcoming event and wanted to make sure I was able to attend. I tested positive for COVID-19 but I did not have symptoms at that time. A few days later I started having more cold like symptoms coughing and sore throat. I had major fatigue and was so tired and was worn out.
Vaccinee experienced "...Failure to achieve antibody titers p/3 doses Engerix-B.
p/vax pt devel inj site react; redness & a bump the size of baseball; seen by MD
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain in arm, vomiting, swelling arm, general body pain and nausea. On an unknown date, the outcome of the fever, pain in arm, vomiting, swelling arm, general body pain and nausea were recovered/resolved. It was unknown if the reporter considered the fever, pain in arm, vomiting, swelling arm, general body pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches, swelling in arm and pain in arm. For tolerance to the 2nd dose refer case US2018101674, reported for the same patient with same adverse events.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. Nurse stated an unspecified dose of GARDASIL 9 series was the only vaccine administered that was improperly stored. Nurse stated GARDASIL 9, Lot # L007495, expiry date 25-FEB-2017, was administered to the patient on 27-AUG-2015. No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
I already have pre-existing conditions of arthritis in my knees and heel. Shortly after the fourth dose I experienced severe flare ups in both that persisted for longer than before.
Nausea, fever/cold chills, Upper right arm and shoulder stiffness and pain discomfort. Lasting over a month until I seeked medical attention from my doctor.
Information has been received from a certified medical assistant concerning a 27 year old female with no pertinent medical history or drug reactions/allergies who on 22-FEB-2007 was vaccinated with a first dose of Gardasil (lot# unknown) 0.5mL IM. Concomitant therapy included hormonal contraceptives (unspecified) for 5 years. On an unspecified date the patient developed brown spots on the face. There is one spot on each cheek. Medical attention was sought. The patient went to a dermatologist (unspecified) and is continuing to see the dermatologist for treatment. No further information was available. At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received. On 28-AUG-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 654702/0011U) IM in the right gluteal. The patien stated that she has been using bleaching cream but the spots reappear if she stops using the cream. At the time of reporting it was unknown if the patient had recovered. Additonal information is not expected.
Patient reported the morning after injection, that her right arm had a red itchy circle around the injection site. She said the circle was about the size of a half dollar. She was instructed to put some hydrocortisone on the area or to take BENADRYL to help with the reaction. She reported improvement throughout the day. Upon recheck on 10/04/18, she reported recovery.
Mom states arm sore within hours, then about 8 hours later swollen, red. Stayed same x 48 hours. Today wanted to go to school - was better - but mom saw was still swollen, slight pain, erythema. Rx Keflex distally x 4"
Left-sided weakness Imbalance Unsteady gait Right sided weakness Frailty Referral to Clinic
On 7/8/09 patient received Prevnar, Hib, Varicella, and MMR vaccinations.  On 7/10/09 patient mother reported that the child has been taken to the ER for a temperature of 104.0.  Patient was sent home same day. On 7/13/09 patient's mother called our office requesting an office visit for fever of 101. Patient was offered an appointment with our extended care office but refused.  Patient's mom did not call back that day.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-DEC-2014, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In January 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.