chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient informed our flu nurse while she was conducting a clinic this year that she had had a severe reaction to last years flu shot. Here is her report: Received flu shot on 11/1/02 in her left arm. Monday, 11/4/02, started experiencing tingling and burning around where she received the shot; this moved down her entire arm. Within the next 2-4 days the tingling moved to her left leg. Had no motor deficits in either the arm or the leg. At this point, she saw her private GP and was eventually referred to a neurologist. The neurologist initially didn't feel it was due to the flu shot, but after attending a conference changed her mind and told her that several other neurologists had noted similar post-flu shot reactions with almost immediate neurological manifestations. Underwent testing; was told there was no nerve damage and the tingling was probably indicative of damage to the myelin sheath and would eventually get better. In March was placed on steroids (10 day course); by April was better, although she was told the episodes might recur. Has since had 2 recurrences, although not as bad as the initial episode--these were focused in her left shoulder and upper arm (not her leg), and consisted of a cold feeling and some tingling. The most recent of these was just several weeks ago (late November 2003). Both of these episodes resolved without treatment after several weeks.
Redness, swelling, erythema 1 day post vaccination, tx cold rags, rubbed w/alcohol, 2 BENADRYL.
Information has been received from a consumer concerning her 2 month old daughter with no known drug allergies who in approximately OCT-2010 was vaccinated with ROTATEQ (dose, date unspecified) and PEDVAXHIB (dose, date and route unspecified) and a dose of DTAP-IPV (dose, date, manufacturer unspecified). On 29-DEC-2010 the patient was diagnosed with Dandy Walker Syndrome which caused the patient to experience hydrocephaly and she was hospitalized. While hospitalized the consumer reported her daughter had surgery to place a ventricular-peritoneal shunt. The consumer reported that her daughter was hospitalized a second time to have a new shunt placed because the first shunt malfunctioned. The consumer reported that her daughter was currently recovering and was stable. The primary reporter considered the Dandy Walker Syndrome to be an other important medical event as well as immediately life-threatening. MRI and CAT scan were performed (results not reported). Additional information has been requested.
Pt received influenza vaccine on 11/6/02 for the first time on the evening of 11/7/02. She had an episode of seizure like activity for 20 minutes. She had repeated flexion of her arms and head that looked like a sneeze but she was not sneezing. No breath holding. NO post ictal behavior afterward. She vomited once prior to the episode. No further episodes. She was sent to neurologist.
sick for several days; Initial information regarding an unsolicited valid non-serious case from a pharmacist via Agency (Reference number- 00606030) and transmitted to Sanofi on 18-May-2021.  This case involves a female patient who was sick for several days (illness), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious, sick for several days (illness), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also reported that the consumer has received a Tetanus shot in the past that contained horse serum.  No laboratories details reported.  It was not reported if the patient received a corrective treatment for the other events.  At time of reporting, the outcome was unknown.  There will be no information available regarding batch number in this case.
Itchy Injection Site; Red Injection Site; Swollen Injection Site; Tender Injection Site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender 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.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
gave patient 2nd booster shot (primary and 1st booster was Janssen). 2nd booster should have been Moderna or Pfizer
Information has been received from a physician via a company representative concerning a 4 year old male patient, with no medical history reported, who on 25APR2003 at 09:15 am was vaccinated into the right lateralis with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) lot 642645/0527M, previously reported as lot 643751/0812M. Concomitant therapy on 25APR2003 at 9:15 am included a fifth dose of alum, potassium + diphtheria toxoid + pertussis vaccine + tetanus toxoid (TRIPEDIA) into the left lateralis and a fourth dose of polio virus vaccine IPOL into the left anterior lateralis. It was noted that the child had BOM at the time of vaccination. Subsequently,the patient developed a "reaction." In follow up information, it was noted that on 23APR2003 at 9:30 am, the patient developed localized swelling and redness to site. The pt was treated with diphenhydramine hydrochloride (Benadryl) 12.5mg (1.5 tsp.). The patient recovered on 23APR2003. No further information is expected. it was reported that the pt recovered at 9:15 am on 25APR2003. No further information is expected.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements.  The patient previously took amoxicillin and experienced allergies.  The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks.  The patient is recovering from the events.   Information on the lot/batch number has been requested.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 1, single (Lot number: fa7584), in right arm, as dose 2, single (Lot number: fa7484), in right arm and as dose 3 (booster), single (Lot number: fj1611), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies cipro", notes: known allergies cipro; Doxycycline, reaction(s): "known allergies doxycycline", notes: known allergies doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 07Jul2022.
Fever 101..1, chills, aches and headache  - taking advil and resting
Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 07-NOV-2011 at the clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. While shingles is a persistent viral condition, the patient has been prescribed vancomycin and acyclovir to manage his symptoms. The patient was later diagnosed by a physician, an Ophthalmologist, for a serious condition in which the shingles spread to his right eye. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Upon internal review, shingles spread to his right eye was considered medically significant. Additional information has been requested.
Fever 101 degrees F, chills, difficulty urination, nausea when he went home after visit.
I have developed a very itchy rash on about 80% of my body that started on 2/28. I also developed a small one approximately 10 days after the first vaccine as well but it was only in 2 areas, my upper thigh and my stomach.
Discharge Provider:  MD Primary Care Provider:  MD Admission Date: 9/14/2022 Discharge Date: Sep 20, 2022  PRESENTING PROBLEM: ESRD (end stage renal disease) (HCC)  Pulmonary vascular congestion  Malignant neoplasm of lung, unspecified laterality, unspecified part of lung (HCC)  COVID-19 virus infection    HOSPITAL COURSE: Patient 76-year-old female with her significant past medical history for stage IV lung cancer, history of breast cancer, chronic diastolic heart failure, CKD stage 4 with planning for fistula in future, presented to the hospital with multiple days of cough, dyspnea, sore throat since 9/12 found to have hypoxia with acute COVID-19 pneumonia. CXR with Mild cardiomegaly and vascular congestion without overt pulmonary edema. BNP elevated and TTE with small new WMA but LVEF normal and no signs of acute new CHF. Patient was not in any acute respiratory distress but needed 2 L of oxygen and was high risk so was admitted. Patient started on both dexamethasone and remedesivir along with supportive care. Improved to room air and remained stable. Plan discharge home with close follow up with both Oncology and Nephrology as well as PCP to consider repeat echo after resolution of covid infection. The patient was educated on need for close followup with PCP and nephrology with repeat labs in 1-2 weeks as her torsemide dose was decreased from BID to daily due to her renal function while inpatient.
This case was reported in a literature article and described the occurrence of cough variant asthma in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced cough variant asthma. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of 11 cases (B0643778A, B0667819A, B0667867A B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 5 subjects who experienced cough variant asthma. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of TDAP, BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13, 427 10 to 18-year-old adolescents who received TDAP vaccinations as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical Td controls match for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the Tdap and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Indented line at the site of the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site indentation in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd September 2019, 3 days after receiving Shingrix, the patient experienced injection site indentation. On an unknown date, the outcome of the injection site indentation was unknown.   It was unknown if the reporter considered the injection site indentation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in his left deltoid. The patient noticed an indented line at the site of the injection on left upper arm. The reporter consented to follow up.
3.0" erythema @ site of MMR inject advised to use ice @ site; advised of precautions & signs of inc/distress; advised to consult MD if condition worsened;
Client presents to Clinic today c/o having a painful bump to right upper arm, Deltoid Region, does not know if it is from HPV vaccine or may be a bug/mosquito bite.  She first felt it about one weeks ago, c/o having chills at times "feeling like I might have a sinus infection", no cough, no fever, no nasal drainage "just wake up not feeling good for the last week", client c/o mild discomfort when arm palpated, slight edema measuring 14 X 13 mm, no erythema, no bruising, Instructed Mother to take client to see PCP ASAP to be evaluated
Vesicular rash on arms and legs, suspect generalized varicella rash due to varicella vaccine administration.
A serious spontaneous report of intussusception has been received from a health professional concerning a two-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 21-Sep-2011. On 23-Sep-2011, the patient experienced abdominal pain and was admitted to hospital and was diagnosed with intussusception. The patient spent one night at the hospital, was NPO and an enema was administered. The abdominal pain resolved and patient was released from the hospital. The outcome of event intussusception was resolved on 24-Sep-2011.
herpes zoster; Information has been received on 09-APR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-OCT-2013, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.   Additional information has been requested.
2nd Vaccine received at approx 10:38am. On arrival to observation area, mother reports patient stated she was not feeling well.  Pt passed out for brief period of  time and was taken to pt care area for further evaluation.  Mom denies hx of seizures  or syncopal episodes. Daughter reports beginning her menses, last night. Reports she ate breakfast this morning and felt fine, before the vaccine. Denies any reaction or issue with 1st dose. BP initially: 88/42, P: 92 O2 Sat: 98% on RA,  fluids given orally. Denies n/v.  BP up to 124/104, P: 78  O2 Sat: 97% Pt became pale again; BP 81/48 .  Call to emergency made services. 1 episode of emesis noted- Pt states she feels better after vomiting; color came back to face; BP:103/62. Paramedics arrived: BP: 108/69 and EKG: NSR @ 90. Mother of pt denied need to take pt to hospital.
severe head ache 36 hours after and a blood pressure rise to 170/70 pulse 66 oxygen was 97 no temp and no I don't have high blood pressure  on Thursday blood pressure was down to 136/66 still had slight head ache  left arm muscle sore for two days on thursday no soreness
received moderna vaccine on his left arm on 2Mar2021 and on 5Mar2021; Sore arm; 16 year old patient received moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received moderna vaccine) and OFF LABEL USE (received moderna vaccine on his left arm on 2Mar2021 and on 5Mar2021) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received moderna vaccine). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced OFF LABEL USE (received moderna vaccine on his left arm on 2Mar2021 and on 5Mar2021). On 02-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received moderna vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      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.  No concomitant medications were reported. No treatment related information has been reported.
My symptoms started around the morning of October 14, 2022. I had a slight sore throat, and my neck was stiff. I tested myself for COVID-19 that afternoon. The result was negative. The following day, I had the same symptoms. I tested myself for COVID-19 again. The result was also negative. The third day, the symptoms persisted. I thought I might have Strep Throat. I visited the outpatient clinic at the hospital. I told them about my symptoms and about my negative COVID-19 test results. They cultured my throat which was negative for Strep. They performed a COVID-19 test. The result came back positive. They prescribed Paxlovid 150mg. I filled it the same day. I took the required dosages. I started feeling better after 24 hours, but I continued taking the medication.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 101.5?, burning in the eyes, sweats and chills, aches, joint pains
Pt recvd 3 Engerix-B vax given 31AUG89, 9OCT89, & 9MAR90 following these titer was neg; pt given 4th dose of vax & 28AUG90 p/4th dose titer was neg;
Acute onset of fever, 102.6 degrees Fahrenheit within 24 hours of receiving the vaccination. Watery Puffy eyes and a fine sandpaper rash on back. Zero rash on anterior torso or extremities.
SHARP PAIN IN ARM (INJECTION SITE ARM); TENDERNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAY-2021, the subject experienced tenderness at injection site. On 20-MAY-2021, the subject experienced sharp pain in arm (injection site arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness at injection site and sharp pain in arm (injection site arm) was not reported. This report was non-serious.