chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed severe viral like illness 48 hours after vaccine. C/O fever 2 days occurred following MENACTRA A and B (mother convinced vaccine related??) 101-102. C/O diarrhea after the MIRALAX last night??? C/O stomach ache very vague but parents gave MIRALAX for constipation. C/O headaches generalized. Denies: nasal congestion, cough, sore throat.
Up to 72 hours after the shot: * Headache * Pain in the injection site (described as sharp pain) * Her face would get very bright, red and flushed; it would remain this way for about an hour, and then go back to normal. Then the cycle would repeat about 2 hours later. * Patient reports alternating between  feeling "feverish" or "really hot" alternating with feeling "really cold" * Dizziness, and very unbalanced on her feet * She fell twice the first two days while trying to walk to the bathroom * Extreme fatigue - she slept most of the first 48 hours * Extreme confusion (more than what was presenting with the Alzheimer's prior to the shot) - she could not remember where she was  Ever since the shot/still experiencing: * Persistent nausea * Constant "achy" feeling in her arms, legs and feet * Panic and anxiety (again, more than is common with her daily routine) * Severely decreased appetite - unable to finish more than half a meal or not being able to eat at all due to nausea/a feeling like she is going to vomit * Her arms and legs are visibly shaky * She is too weak often to lift herself out of her recliner (she was able to do this prior to the shot)
FLUMIST given 8-22-12. Seen here for rash & redness left eyelid 8-28-12 and again 8-31-12 with severe impetigo both nares, face, ears & foot.
Reports he fainted for few minutes. History of similar symptom with venipuncture. BP: 134/94 and 150/103 ( repeat) Fingerstick: 121 HR: 60 Sp02: 99% RA Refused to be transported by EMS to ER. Refusal form signed by patient  Seen and cleared by EMS,
Patient received shot from our technician and immediately began to lose conciseness.  He never fully lost conciseness, but was very pale and began sweating. Patient was moved for the chair to the floor. He was given orange juice and 911 was called by the staff pharmacist. After about 10 - 15 minutes, patient began to return to normal color and sweating had stopped. First response arrived, checked vitals, and patient left with his mother, who was present throughout the event. Patient declined ambulance transport.
missed second dose; tested Positive for Covid19 5 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested Positive for Covid19 5 days after first dose) and PRODUCT DOSE OMISSION ISSUE (missed second dose) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested Positive for Covid19 5 days after first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, COVID-19 (tested Positive for Covid19 5 days after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient received the antibodies 7 days after the first dose, it has been just about 90 days after the antibody treatment. No concomitant medications were reported.  Company Comment: This case of Product dose omission issue, concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected event of COVID-19. The patient tested positive for COVID-19, 5 days after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was resolved. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case of Product dose omission issue, concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected event of COVID-19. The patient tested positive for COVID-19, 5 days after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was resolved. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient reported onset of cold chills and hot flashes intermittently and rash to left arm that migrated to legs on 9/18/2007. Reports that had been vaccinated with Td on 4/21/2007 at local emergency room but failed to disclose that information until after Tdap was administered.  Was seen by primary care provider on 9/19/2007 and symptoms resolved spontaneously on same day. Took Ibuprofen 200mg once daily for 2 days.
Patient reports sudden onset sore throat/ itchiness that occurred several hours after he received the vaccine and around the same time his wife had same symptom and she had received vaccine as well. He didn't take anything to alleviate symptoms and they went away on their own a few mins to hour later.
2-3 hrs after injection c/o itching, burning, numbness and pain all rec. Severe itching, no whelps noticed until after child began vaccinating. No fever in site area. Unable to move arm when woke up. Now full range of injection
Pt is doing well, acting normal, smiling playing and responsive. Parent has not reported any abnormality.
Patient had his Booster Covid vaccine the day before. The next day in the afternoon, he felt light headed, went to the bathroom to run water and he fell. He was "out of it" for a few seconds and then came to. He was seen and back to baseline
Pneumonia; Patient has not gotten second dose passed 42 day; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten second dose passed 42 day). The patient was hospitalized on 28-Mar-2021 due to PNEUMONIA. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten second dose passed 42 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Other treatment medication included unspecified antibiotics.  Company Comment: This report refers to a case of Product Dose Omission Issue for mRNA-1273 (Lot #: Not Provided)  with the associated adverse event of Pneumonia. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product Dose Omission Issue for mRNA-1273 (Lot #: Not Provided)  with the associated adverse event of Pneumonia. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received PPSV23 on 10/20/2015 in right upper deltoid. Patient developed redness in right upper arm, which started spreading to lower arm on 10/23/2015. No pain reported. Came as walk-in to clinic on 10/23/2015 and per exam, no confluence or warmth of red sites. Diagnosed with cellulitis s/p PNEUMOVAX.
4/16/2021: Vertigo (30 sec.) when laying in bed ( 12:30 PM for about half hour)  and occurred again after I got up. Had not eaten prior and drank a lot of water after and no further incident occurred. I had taken an 1.5 hour walk in the morning. Fatigued  4/17/2021: Vertigo occurred during half hour yoga video session when I laid down on the mat. Approximately 30 seconds.  Discontinued session and rested remainder of the day. No further events. Also drank 7 glasses of water with two cups of tea as I thought I was dehydrated. Fatigued remainder of the day.  4/18/2021: No vertigo but did not exercise and rested all day. Fatigued.  4/19/2021: Vertigo with yoga session twice in the  morning.  Approximately 15-30 seconds. Went to clinic to vaccinate residents and felt tired, but no further events. 4/20/2021: Vertigo occurred three times during yoga. Felt lightheaded after. Went to see primary health care provider at 1:30 PM in person and felt it was BPPV and provided at home instructions. Felt lightheaded in office when I stretched my neck to look up and when I got off of exam table. Vertigo occurred again when I went to lift my head to hang clothes on the line in the afternoon. No appetite. Hydrated again well and did eat. Fatigued remainder of the day.  Nauseated in the evening and vomited due to vertigo.  4/21/2021 Vertigo severe in the morning and dry heaves after I woke up. Unable to attend vaccine clinic this day as I was so unbalanced I had difficulty ambulating. Just rested remainder of day. Could not perform exercises Dr. had suggested for BPPV . Fatigued. 4/22: Slightly  improved through the day. Able to perform some of the exercises Dr. had suggested. 4/23/2021: Felt better. Vertigo lessoned throughout day 4/24.2021: Resolved.  Vertigo lasted for one week.
got very sick; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 15:30 (Lot number: ER8733) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arrythmia" (unspecified if ongoing); "Low IGG" (unspecified if ongoing); "covid", start date: Feb2021 (unspecified if ongoing), notes: I had covid in Feb 2021. Concomitant medication(s) included: ZOLOFT. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very sick". The event "got very sick" was evaluated at the physician office visit. Clinical course: She had covid in Feb2021 and that is why she waited longer in between her 2 vaccines because she got very sick after her 1st vaccine and doctor told her to wait a bit for the 2nd.
Information has been received from a registered nurse (R.N) concerning a 15 year old female who on 27-OCT-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL. On 18-JAN-2010 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL. It was reported that on approximately 18-JAN-2010 the patient developed headache, vomiting and stomach ache "for the past 10 hours". At the time of this report, the patient's symptoms persisted. The patient didn't sought medical attention. Follow up information was received from the physician who reported that there was no clear relationship between vaccine administration and vomiting. Follow-up information was received from the registered nurse. It was reported that that doctor determined that these events were not related with GARDASIL. Additional information is not expected.
Slept since immun yesterday, h/a, vomiting, fever 102, lethargic, lt arm red/swollen; mom administered APAP 21AUG91;
pt to hospital with c/o fatigue and weakness, coughing, husband with similar symptoms; DNI; positive for COVID; O2 sats 88% on RA, given O2 supplementation via NC; pt was doing better and planning to go home when she was found unresponsive; code stroke called; head CT was negative; placed on BiPAP; pt's condition worsened; developed arrhythmia and hypotension; family called to hospital, but pt passed away before family arrived
Fever; Choking; chest pain; Injection site induration; malaise; injection site erythema; dyspnea - Information has been received from Wyeth-Lederle for pneumotoccal vaccine 23 polyvalent (Pnu-imune) and assigned manufacturer control number HQ768204Oct2000.  The report concerned a 43 year old female with herpes simplex, who on approximately 01 Sep 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 635466/0782k.  On 06-Sep 2000 the patient was also vaccinated with pneumococcal vaccine 23 polyvalent (pnu-imune 23) lot #463-015).  On 07-sep-2000, approximately 24 hours post vaccination, the patient developed an injection site reaction characterized by redness and induration.  She also developed a fever of 101 degrees F that lasted for 1 to 2 days; then a fever of 99 to 100 degrees F.  She also experienced malaise, shortness of breath, a choking sensation and chest tightness.  The reporter stated that the injection site reaction had resolved, but the other events were ongoing at a lesser degree.  The physician felt that these events may be related to an injection of measles-mumps-rubella vaccine that the patient had received one week earlier.  This information was originally received from a physician.
patient describes symptoms starting the evening of  march 13, 2022 of tightness of chest which lasted approximately 24 hours with about 1 hour of actual chest pain during that time.patient went to ER  early morning march 14.  she reported to me that both her blood work and EKG were normal.
Redness, swelling, warmth to the touch-about 4 in. in diameter.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy, medical history, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of one of improperly stored vaccines. The improperly stored vaccines were as follows: GARDASIL 9 injection, lot# M016193 with expiration date 24-APR-2018, lot# M020103 with expiration date 15-FEB-2018, lot# M011840 with expiration date 01-FEB-2018, lot# L037554 with expiration date 25-DEC-2017, lot# M007764 with expiration date 30-JAN-2018 or lot# M009362 with expiration date 13-JUN-2018 (dose and route of administration were not reported), VAQTA injection, lot# L023936 with expiration date 15-MAR-2017, lot# M036459 with expiration date 18-JAN-2018, lot# L015460 with expiration date 20-JUL-2017, lot# L046953 with expiration date 14-JAN-2017, lot# L045713 with expiration date 14-JAN-2017 or lot# L041676 with expiration date 15-MAR-2017 (dose and route of administration were not reported), RECOMBIVAX HB injection, lot# L014418 with expiration date 13-APR-2017, lot# reported as M011671 with expiration date 02-JUN-2018, lot# M029026 with expiration date 18-NOV-2018, lot# L027733 with expiration date 13-SEP-2017, lot# L039660 with expiration date 04-FEB-2018, lot# M000442 with expiration date 31-MAR-2018, lot# L029631 with expiration date 14-AUG-2018 (dose and route of administration were not reported), PEDVAXHIB injection, lot# M006710 with expiration date 06-DEC-18, lot# L004740 with expiration date 16-NOV-2017, lot# M001811 with expiration date 04-NOV-2018, lot# M014927 with expiration date 18-FEB-2019, lot# M027882 with expiration date 14-APR-2019, lot# L014427 with expiration date 09-MAR-2018, or lot# K025005 with expiration date 21-JUL-2017 (dose and route of administration were not reported), ROTATEQ taken orally, lot# M014318 with expiration date 30-SEP-2017, lot# M007307 with expiration date 30-NOV-2017, or lot# L013206 with expiration date 29-JAN-2017 (dose was not reported), PNEUMOVAX 23 vials, lot# M029680 with expiration date 17-JAN-2018 or lot# M026317 with expiration date 11-JAN-2018 (dose and route of administration were not reported). Reporting nurse was not sure which of the vaccines the patient received. There was no adverse effects reported. Product quality complaint (PQC) was not involved. The vaccines were exposed to the temperature between 32 and 36 degrees Fahrenheit for 9 days (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. Additional information has been requested.
5-yr. imm. rec'd on 9-16-14. (LA) with redness and edema no warmth began 9-17-14. (+) low-grade fever on 9-18-14. Seen 9-19-14 for s/s. (10 x 8 cm area erythema on (L) upper arm without induration or tenderness. Tx'd with ibuprofen, warm compresses and return if s/s increase.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced 65 chickenpox throughout the body. Only five of the chickenpox were large.
This spontaneous report was received from a pharmacist refers to a 5 month old patient. On 26-MAR-2014, the 5 months old patient was vaccinated with GARDASIL (dose, route and frequency were not reported). No symptoms were reported. No further details were provided. Additional information has been requested.
pt recv vax 30OCT98 & pt exp swelling on the lt side of face, rt shoulder, & both hands as well as shoulder & joint pain;pt sought unspecified med attention;3NOV98 results of CBC count WNL pt erythrocyte sed rate had inc to 108;
pt exp apnea for few seconds resolved quickly;pt stopped breathing again;when came to office 2-3min distance pt pink, spontaneously active;adm to hosp
Diagnosed Stroke resulting in left side paralysis of left arm and left leg. Hospitalized for 28 days  Medical Center. Follow on with 6 weeks of in-home therapy and presently out-patient therapy both OT and PT as well as Speech. Using wheelchair and walker.
administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature; Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) in an 80-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The vial was first punctured on 25-Jul-2022 around 10 AM and then it was left unattended and kept at room temperature range (8 to 25 degree Celsius/46 to 77 degree Fahrenheit) for 23 hours. The vial did not undergo any temperature excursion.  It was reported that the vial was never in the fridge and it was moved from the freezer to room temperature directly on 25-Jul-2022.  No treatment medication details was reported.
Information has been received from a consumer concerning her granddaughter, a 17 year old female with constant urinary tract infections and drug allergy to antibiotics (name unknown) who in April 2009, was vaccinated with the 3rd dose of GARDASIL (Lot# not reported). Concomitant therapy included birth control name unknown. On the date of last injection in April 2009, patient said she felt the injection itself was painful. A few weeks later in April 2009, she started to experience some side effects: fainting, nausea, dizzy, constant yeast infections, irregular periods, spotting between periods and overall not feeling well. 5 months later, grandmother had to take consumer several times back to her healthcare professional (HCP) for severe back pain, leg pain, raised bump on left leg, and still experiencing throwing up, severe dehydration for which consumer had to be hospitalized in 2011. Grandmother said the patient also while in hospital experienced a seizure, caller did not specify month or date. Caller also reported weight loss consumer went from 123 lbs to 98 lbs. Consumer continued to have the severe side effects which HCP had not found out how to treat consumer. It was also reported the laproscopy was performed on an unspecified date for this patient without giving the lab result. The adverse events was not improved and the patient had not recovered at the time of reporting. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Injection site soreness; Body aches; chills; nausea; Slight increase in blood pressure; increase in pulse rate; headache; Feeling of being unwell; Heart is pounding; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 28th June 2019, refer linked case US2019AMR158858).   On 28th August 2019, the patient received the 2nd dose of Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the general body pain, chills and nausea were not recovered/not resolved and the outcome of the increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced a feeling of being unwell which includes body aches, chills, nausea and headache. The patient stated that her heart was pounding with a slight increase in blood pressure and also reported increase in pulse rate.  The reporter consented to follow up.