chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed patient begin to have jerking movements as he was going to sleep.  They were mild at first, but continued to get stronger as time progressed.  I took him to the pediatrician in January for these incidents, and he referred him to a neurologist.  Patient's seizure activity escalated to gran mal seizures in February.  He has been under a neurologist's care since March, when he was tenatively diagnosed with generalized epilepsy and must undergo more test to see the severity of his epilepsy.  We are not sure if this will result in a permanent disability or not.  Hopefully, he will heal from the injury to his nervous system.   11/10/09 Medical records received for DOS range 12/1/08-4/29/09. PMD visits and neuro consult. Final DX Seizure disorder, Upper respiratory infection.  First febrile seizure 5/2008. Viral syndrome temp 104.  12/1/08 Followup visit for OM. Vaccine given Jerking movments on awakening since 27 mos.  Increased jerking movments during sleep. Progressed to myoclonic seizures upon wakening. Then OMx2, cold and sinus. Jerking while falling asleep and awakening noted at the time, some head droop. Long term EEG abn. 2/23/09 tonic clonic non-febrile seizure. X30 secs. Postictal x20 min.  Mutltiple OM and URIs throughout records.  ICD9 Codes: 345.90, V04.81, 381.1. 381.01, 472.0. 790.8, 786.2, 388.7, 465.9, 780.31, 388.7, 307.4, 461.9
no additional adverse event; three doses of ROTATEQ were administered following a temperature excursion; This spontaneous report was received from a medical assistant and 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 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml once, orally, lot # 1691308, expiration date 28-NOV-2021 for prophylaxis. The vaccine experienced a temperature excursion, however, at the time of reporting, the reporter was waiting for multiple excursion form to be returned so no details were provided. Digital data logger was not involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA008565:
Pt called and asked if the shot is why her baby was born on 9/16/00 and has chromosome abnormalties. Her due date was questionable. Baby weighed 14 lbs and 15 ounces. First learned she was pregnant on 2/6/00. Baby to see specialist on 11/5/00. Follow up states: Not really an adverse event per se: Pt is a 17 yo female who gave birth on 09/16/2000 to an infant who apparently has chromosomal anomalies. The mother was inquiring about the possibility that a Hep B vaccine she received on 01/06/2000 may have played a role in the baby's condition.
had fever 104 R for 12 hrs taking APAP; was quiet; temp nl 930AM 28APR92; mom talked to MD next AM; MD recommended DT w/next vax;
Copied from Database. Topic: Acute Illness >> Apr 26, 2021  8:30 AM wrote: POS SCREEN Pt started having Sx on 4/23, sinus congestion.  Pt stated yesterday he had a temp of 101F and sore throat and crackling in ears.  Pt stated he has received both Covid Vaccine injections.  Please advise. Thank you
tinnitus; headache focused behind her left ear.the pain was her skull behind her left ear; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), EAR PAIN (headache focused behind her left ear.the pain was her skull behind her left ear), FATIGUE (tiredness) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     The patient's past medical history included Tinnitus and Colonoscopy. Concomitant products included ANASTROZOLE and VITAMIN D2 from 17-Mar-2021 to an unknown date for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FATIGUE (tiredness) and HEADACHE (headache). On 06-Apr-2021, the patient experienced TINNITUS (tinnitus) and EAR PAIN (headache focused behind her left ear.the pain was her skull behind her left ear). On 05-Apr-2021, FATIGUE (tiredness) and HEADACHE (headache) had resolved. On 06-Apr-2021, EAR PAIN (headache focused behind her left ear.the pain was her skull behind her left ear) had resolved. At the time of the report, TINNITUS (tinnitus) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not reported.  Patient 2n dose was due 05-may-2021.
Received a notice to schedule the 2nd vaccine and she reported to vaccine site 6 days earlier.  The nurse did not verify the fist vaccine date before administering the 2nd vaccine.
Excessive discharge of fresh flowing blood occurred from the vagina/I also had vaginal discharge of clotted blood; menstrual cramps; fever (102F); Chills; muscle aches; persistent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Sep2021 15:30 (Batch/Lot Number: EW0179) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included illness from Oct2020 to Nov2020 Identifiable symptoms of the COVID-19 disease. During that period of sickness, the patient's female reproductive cycle was not affected. Following the first shot of Pfizer on 17Sep2021 the patient started experiencing adverse effects.  It began approximately three (3) hours (18:30) following the shot. Excessive discharge of fresh flowing blood occurred from the vagina, which did not lessen until the following day.  In those first several hours of bleeding, the patient also had vaginal discharge of clotted blood.  For seven days, the patient continued to have minimal amounts of vaginal discharge and menstrual cramps. In relation to her menstrual cycle, these adverse side effects took place during the beginning of my proliferative phase. For approximately forty-eight (48) hours following the shot, the patient experienced similar side effects that have been previously reported by Pfizer: fever (102F), chills, muscle aches, and a persistent headache. The patient underwent lab tests and procedures which included pyrexia: 102 fahrenheit on Sep2021. The patient did not receive treatment for the events. It was unknown if patient had covid prior vaccination. The patient was not covid tested post vaccination. The outcome of the events was recovered in Sep2021.   Follow-up attempts are completed. No further information is expected.
patient reports "feet feel dizzy and chest feels funny" and mild headache.  Patient laid down, neuro exam wnl.  At 11:48am, patient reports feeling relief.
Mild itching on right deltoid started on the afternoon of 1/22. Sensation lasted about an hour.  Mild itching continued daily in the afternoon for about an hour. On 1/27 I woke up with a rash near the injection site (R deltoid). Area is red and warm to the touch.  Area is itchy throughout the day and continues this morning
Sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.   This case was linked to MOD-2021-034014 (Patient Link).
W/in 24 hrs PT seen in ER; given Cephradine--improved in 2 days; discontinued p/4 days because of diarrhea; inc T, redness, swelling arm--w/in elbow shoulder area--not totally encircling arm; dx of cellulitis
kind of bed for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (kind of bed for 2 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (kind of bed for 2 days). At the time of the report, BEDRIDDEN (kind of bed for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were provided by reporter.
Patient reported headaches , strange taste  on her mouth, and tingling on the left arm  2 minutes after getting the vaccine.  As per staff: Patient was A/O, Denies SOB, Palpitation, Throat itchiness or closing.  Her vitals signs were: BP:120/74, HR:92 and Regular RR:20, Lung clear. Apple juice given. Patient stated feeling better around 0355 and discharge home with instruction to call heath care provider if symptoms persist
baby is 2 months old and I'm breastfeeding; baby is 2 months old and I'm breastfeeding; experienced excessive breastmilk increase; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 29Jun2021 14:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 30Jun2021 06:00, outcome "unknown" and all described as "baby is 2 months old and I'm breastfeeding"; LACTATION PUERPERAL INCREASED (non-serious) with onset 30Jun2021 06:00, outcome "unknown", described as "experienced excessive breastmilk increase". Therapeutic measures were not taken as a result of off label use, product use issue, lactation puerperal increased.  Additional information: No COVID-19 was prior vaccination. No COVID-19 tested post vaccination. No Known allergies.   Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021817541 Same patient/drug, different patients/events
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
Warm reddened, itchy area on right deltoid from top of shoulder to approximately 1 inch below deltoid.
Brachial neuritis left shoulder and upper arm within a week after vaccination. The ER record and medical record received on 1/6/04 confirms diagnosis of brrachial neuritis.
This subject is a 76 year old male who died on 7/24/03 due to his emphysema while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/10/02. The subject died 287 days post immunization. The subject's family phoned on 8/15/03 to notify the investigator that the subject expired from emphysema on 7/24/03. The event was reported by the investigator as unrelated to the study product. A 15-day follow up report received 8/26/03 adds: Additional info received 08/22/2003. Previous medical history received and available in source documents. Discharge Summary: 04/24/2002. History and Physical: 04/24/2002. Progress Notes: 1/4/00, 1/25/00, 3/6/00, 3/1/01, 6/29/02, 7/8/02. Final diagnoses: 1. Exacerbation of chronic obstructive pulmonary disease with bronchitis. 2. Gastrointestinal bleed secondary to polyps. He will be discharged on Atrovent metered dose inhaler two puffs p.o. q6h. Ventolin metered dose inhaler two puffs spo q6h. Theophylline 300mg po bid, Ceftin 500mg po bid for the next five days and Prednisone 6mg po once a day to be tapered as an outpatient. Diet and activity can be as tolerated. He will follow-up with myself and with Dr. Hospital Course: He was admitted for exacerbation of COPD. He was placed on bronchodilators, antibiotics, oxygen and IV Theophylline and steroids. He showed a steady improvement as his medication was tapered on the final hospital day. He was back to his baseline and did not have dyspnea on exertion. While in the hospital, he had an episode of GI bleeding. Dr. was consulted. Colonoscopy was done. He had noted to have a rectal mass and multiple colon polyps and anal stenosis. Biopsies were done. H&H remained stable. At this time, no further in-hospital management is planned and he can be followed as an outpatient. Impression: 1. Severe COPD. 2. Weight loss. Maintain Prednisone at 20mg per day. Continue on Pulmicort, Atrovent, and Albuterol. Follow-up again in one month. Death certificate states congestive heart failure. Additional info received 9/19/03. Follow up report. Diagnosis: Emphysema, chronic obstructive pulmonary disease, congestive heart failure. Progress notes: 9/19/03. Patients certificate of death received and noted. Immediate cause linked as COPD and congestive heart failure. Review reveals no evidence of cong. failure in this facility. Pt received his injection of RSV vaccine in Oct. 2002. Deceased July 24, 2003. Death certificate received. Cause of death: End stage chronic obstructive pulmonary disease, congestive heart failure. The investigator assessed the events as unrelated to the study products. Follow up on 09/17/2003: "Additional information received 09/05/2003.  Family reports death certificate states: A-End stage of chronic osbructive pulmonary disease.  B-Congestive heart failure.  Copy pending.  Diagnosis: Chronic Obstructive Pulmonary Disease, Emphysema.  The death was reported by the investigator as not related to the study product."
Headache, recurrent, intermittent, mildly disabling at times. Addressed by neurology, neurosurgery, endocrinology and psychiatry w/o effect.
Joint swelling in hands, hips, spine and shoulders, Muscle pain including knots in spinal erectors, neck, trapezius muscles,, biceps and triceps. Headaches.  What is concerning is that these sxs have persisted and continue to be salient at 13 days from date of vaccine. On day 7, I had nausea with vomiting.  Continued pain at injection site at day 13.
35 minutes after vaccine: Slight headache & slight nausea 6 hours after vaccine: Left upper arm extremely stiff & tender. Tired/sleepy feeling. 8 hours after vaccine: EXTREME exhaustion, legs, arms stiff [unable to turn over in bed] (Water/Coffee/Tea intake). 1 day after vaccine: VERY EXTREME exhaustion, difficulty walking, moving. No appetite. No bowel movements(Water/Coffee/Tea intake-very high-very little urination)-slept 10 hours. Vaccination site extraordinarily sore & stiff. Still difficult to turn over in bed. 2 day after vaccine: EXTREME exhaustion occurs in waves.  Sleeping over 12 hours-cannot stay awake. Stiffness subsiding.  Vaccination site no longer sore, stiffness subsiding.   3 day after vaccine.  Still exhausted.  stiffness very light.  Still require 10 plus hours of sleep.
1-2min sz-no tx resolved;hosp admission-phenobarb level found to be subtherapeutic;
Sore arm at first, then about 24 hours after the vaccine, chills, low grade fever (100 degrees), achey joints/muscles
Extreme fatigue - throughout the entire day Chills began late afternoon Low Grade Fever 99.7
Patient received 0.3 ml of undiluted Pediatric Pfizer Bivalent vaccine, we he was to receive adult Pfizer Bivalent, no abnormal adverse reaction reported. At follow up call, she said her symptoms seemed milder and lasted longer compared to previous vaccinations
During receiving his shots he screamed and cried louder than any other time in the past.  He cried for about 2 hours straight afterwards.   Once home, he complained how bad it was hurting. The swelling increased about every hour on his left arm where the shots were put in.  He could not lift his arm up AT ALL. It was as red as a firetruck, tender to touch and burning hot.  His entire shoulder and upper arm swelled up 3x the normal size.  I brought him back to the Pediatrician office the very next day. The nurse gasped and put her hand over her mouth when she saw his arm. The doctor came in and said this was normal and it happens all the time . He stated to just give him benadryl and Tylenol or ibuprofen for pain. And said if his arm is not better in 2 weeks to bring him back.   He had little to no movement of his left arm for 2 weeks. It also took 2 weeks for the swelling to even START to go down.  Not only that, but he is now traumatized and petrified to go to the doctors since this happened.
Called to assist with post vaccine reaction on individual in Observation area at 12:04.  Approached patient in chair who had eyes closed and stated she was itching all over and dizzy.  No hives.  No rash noted except local reddness extending about 3-4 inches around injection site.  No diaphoresis.  Skin without pallor.  Alert and oriented x3.  Coworker Rn drawing up benadryl 50mg to be given IM  by RN at 12:09 in right upper extremity. Vital signs 122/70 , HR 72, RR 16-18.    Continued  to assess patient at chair side who sipped on water.  No nausea.   Patient continued to complain of dizzyness while itchy sensation diminishing.  Vital signs BP 118/70  Hr 78, RR 16. .  Color remains pink.  No rash.  Itching only in upper extremeties.  Legs elevated on chair.  Pt refused to lay on stretcher.  Stated she no longer felt dizzy and only left arm itched. Eating protein bar.  Vital signs rechecked after standing patient upright.   BP 116/78 HR 80 RR 20.  Pt wanting to go home.  Observed her for 30 minutes post benadryl injection.  Ambulated out of observation area symptom free and insisted on driving self home.  Warning signs reviewed regarding vaccine reaction and aware to react to the onset of further or worsening adverse vaccine reaction.
Pt woke in AM with 2 blisters on trunk and they continued to spread through out day on trunk and face @ 10-12 spots.
Information has been received from a registered nurse in a physician's office concerning a 61 year old female with no allergies and no medical history who on 14-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot 659615/0162X). There was no concomitant medication. On 15-MAY-2008, after the patient received zoster vaccine live (Oka/Merck) a rash appeared on the area of the patient's wrist to the elbow of the vaccinated right arm and also some on her left arm. No lab test were performed. The patient called the physician's office to report her experience. As of 16-MAY-2008 the shingles type rash persisted. Additional information has been requested.
Child experienced a nose bleed from left nostril (blood was running out of the child's nostrils) on May 24, 2021 around 4:30 a.m.  Nose appeared swollen. Nose bleed lasted about 5 minutes. Parent used tissue to help stop nose bleed and sat child in an upward position. Child remained alert and normal throughout the process. Child has a history of occasional nose bleeds but has not experienced a nose bleed prior to this incident in over a year.
Rash and Nausea began 1 day after vaccine. Intermittent headaches since 1 day post vaccine. Denies anaphylaxis.
Patient describes becoming dizzy after getting second MODERNA COVID-19 dose about three days after. Patient reports feeling lightly dizzy almost on a daily basis having one to two episodes per day.  Usually having the first episode at the start of the day and getting the second one at the end of the day when resting.
Mother of patient called immunization clinic at 1:15pm today 01/09/2009 asking for nurse who administered vaccination to her daughter. Mother claims daughter came home from high school today (01/09/2009) sick, having vomiting and diarrhea, with pain to the right upper arm and looked swollen. Mother believes child will die from the HPV ("the girls shot") due to information she gathered from her internet search. Mother stated "What should I do?". I expressed concern and needed more data from mother and crossed-check clients immunization consent form from 01/08/2009. It indicates that I was the administrator of the immunizations and that the HPV #1 dose was given on the Left Upper Deltoid (IM) and the Meningococcal Conjugate (MCV) on the Right Upper Deltoid (IM) with the Varicella #2 dose to Right lower arm Tricep (SQ). I strongly recommended Ice Pack or Ice Cubes inside a zip-lock bag as tolerated by client to Right Arm and/or what mother has previously given child for muscle discomfort, like Tylenol or Mortrin. If S/S continued next 24hours, mom would need to take daughter to ER of choice for follow-up. Mom agreed.  1/12/09 T/C to Mom states pt is no longer ill but mentally scared & will not go to school.  Has not seen MD or gone to ER.  Only researched on internet & is now afraid she is going to die.  Not physically ill.  Strongly encouraged Mom to have patient seen by MD or go to ER for reassurance & medical testing.  Refuses.  Gave Mom CDC NIP info phone # for additional info.
I got fever of over 104F on July 3 and was sent to emergency room on July 3 and 4. After CT scan doctor found consolidation on right lower lung lobe and diagnosed I was having pneumonia although I received PPSV23 injection just over one month ago.
EXPIRED VACCINE USED; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that no treatment was provided to the patients. Concomitant medication was not reported. It was reported that the vaccine was stored in the freezer and they would take out one to two vials and keep in the fridge as needed each day.