chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received 07 April 2009 from a consumer who was the patient's mother-in-law.  A male patient (age not reported) with a history of sleep disorder, had been exposed to a bat and received their first dose of IMOVAX rabies vaccine (lot number not reported) at a local health department on an unspecified date during November 2008. The patient had no concurrent illness at the time of vaccination. The patient received the remaining doses of the post exposure IMOVAX rabies vaccine series at a physician's office, and an unspecified amount of time after receiving the fourth or fifth dose, he developed slurred speech, his hands and feet became swollen and his thought process became affected and were not clear and concise. The patient was evaluated at the emergency room on 04 April 2009. Diagnostic testing included an EEG within normal limits and a CT Scan of the head with normal results. The patient was advised to follow-up with a neurologist. At the time of the report, the patient had not recovered from the event. No additional information was provided at the time of the report. Documents held by sender: None
Patient received additional full dose of Moderna vaccine after reporting only having completed initial series of Moderna COVID vaccine series. Immunocompromised status confirmed. Verified number of doses with patient and on immunization website (2 submitted). Patient then returned to clinic later with vaccine card that showed 3 total doses.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Pregnancy (Live, full-term birth) on 28-Dec-2017. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Mar-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Biopsy chorionic villous: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Prenatal vitamins. Treatment details Fertility treatments Estimated date of conception in 2020. Patient had previous pregnancy on 28 DEC 2017 with live birth.
The temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case via health professional.   This case involves adult patient being administered Influenza Quadrival A-B Vaccine [Fluzone QIV] post-excursion with no reported adverse event and reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA409526, 2022SA409694, 2022SA409707 and 2022SA408679.   On 23-SEP-2022, the health care professional reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error).  On 23-Sep-2022, the adult patient being administered post-excursion suspect Fluzone QIV NP vaccine at dose 0.5 ml (lot:  UT7689LA, expiration date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency.  Action taken: Not applicable.   At time of reporting, the outcome was Unknown for both events.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After check-out I was looking over the sales slip and re-arranging items in cart. I took one step backwards and tripped over the "barrier" cone in front of the customer service desk. I fell over backwards, landing on right buttocks and head.  It's possible that I fell as result of dizziness from the vaccine shot, but more likely that I was simply not watching my step.  I'm in good physical shape and in fact just before the vaccine I participated in an aerobics class.  Alerted doctor's office and advised to use ice on buttock injury.
Male, 54 years. On Monday October 10, 2022, I was administered the GSK influenza vaccine. The next day, October 12, 2022, I started to feel discomfort in my thorax with an irregular heartbeat. The irregular heartbeat lasted throughout the day in the following day October 13, 2022. I used my finger to check my pulse rate and noticed that at irregular intervals there is a pause in heartbeats. At this point I decided to take a ecg and was able to capture the graph with the irregularities. Today, October 14, I am feeling better, but will continue to monitor. I have the ecg if you need me to submit. On another note, I would like to mention that my father in law 89, also took the flu shot and experienced the same symptoms of irregular pulse rate.
This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergie/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of GARDASIL injection (lot # L006549 with expiration date 06-APR-2017 and lot # K008931 with expiration date 04-MAR-2017; dose and route were not provided). There was no concomitant medication. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
BILATERAL SWOLLEN LEGS FROM HIP TO FEET; SWOLLEN TESTICLES; DIFFICULTY AMBULATING UPSTAIRS; DIFFICULTY PUTTING ON SHOES; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and aortic aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included furosemide for heart surgery. On 04-MAY-2021, the subject experienced bilateral swollen legs from hip to feet. On 04-MAY-2021, the subject experienced swollen testicles. On 04-MAY-2021, the subject experienced difficulty ambulating upstairs. On 04-MAY-2021, the subject experienced difficulty putting on shoes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swollen legs from hip to feet, swollen testicles, difficulty ambulating upstairs, and difficulty putting on shoes. This report was non-serious.
The day after my fist dos I got a patchy,  red rash on the inside of my forearms. It lasted about a week and then went away.  I did not associate it with the COVID vaccine.  A month later I received my second dose and five days later I got a red, raised, splotchy, itchy rash on my elbows and ankles. I saw my doctor about it a few weeks  later when it didn't resolve. She put together that the rash and vaccine were connected. I could control the itchiness with OTC anti-histamines but it didn't go away. I continued to worsen over the next two months!  Eventually I went on a strict low histamine diet and it began to clear.  I still (7 months later) cannot eat some high histamine foods without the rash returning, though I previously had no food allergies.
Bexsero vaccine was given at our office at approximately 3:30 pm. The patient waited in our office for approximately 30 minutes before leaving our facility and on her way home. She started feeling body aches and pain about an hour and a half after leaving our facility. Tingling throughout her body, dizziness and shortness of breath also developed within a matter of minutes. After about 30 minutes she fainted and her mother brought her to hospital. At the hospital, oral pain killers were given along with 2 bags of IV fluids. She was monitored in the ER for 5 hours because of the increase in her pulse rate alongside with her dizziness. the patient was discharged and is still having pain in her arm.
Left arm red, warm, and mildly tender. Redness extends from top shoulder to below elbow. Swelling noted as well.
Pt vomited small amounts after nasal inoculation. Pt AO x3 warm, slightly diaphoretic. Pt feels pressure in nasal cavity. Pulse 70, B/P 130/80, SPO2 98% 1655 hrs. Pulse 64, B/P 120/80 1707 hrs.
Child developed severe abdominal pain on 7/22/10. He was very irritable, screaming from the pain, vomited once, seen in ER, had bloody stool there. Intussusception was diagnosed, laparoscopy surgery was done at hospital - on 7/23/10.
Headache, Myalgia, Diarrhea, NauseaVomiting, FATIGUE Narrative:
Pt received injection 9/25/07 at 11:00 am. At 1:00 am 9/29/07 pt developed erythema and edema of fingers, knees and ankles then pain and stiffness. This continued off and on 9/29/07 9/30/07 then resolved on 10/1/07. Labs drawn on 9/28/07 and started Aleve twice once 9 am.
Pt had hip pain,  scan showed Pelvic bone cancer mets; had been cancer free since 2012
About 7pm I started feeling terrible chills and headache. by 10pm I had extreme body aches, bones , muscles, etc.  Headache was very intense,eyeballs ached ,face etc. I was dizzy, jaw was stiff but mostly terrible pain. had some wheezing by it went away when I coughed up mucus. Had a 101.5 degree temperature all night which went down to 100 in the morning and back up to 101.2 later on the 14th.  I had nausea and extreme pain all over my body and restlessness.  it got a little better the next day but still feels like I have the flu. I had covid back in march of 2020 and was tested for the antibodies at the end of August.  There is a horrific dearth of research on people who have had covid and whether they should get the vaccines. It is disgraceful, and the next time I will listen to my gut which told me NOT to get vaccinated!
None from vaccines except sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2 (BNT162B2), on 16Apr2022 as dose 3 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer / Biontech COVID-19 vaccine (DOSE 1, SINGLE, Lot number: EL9262), administration date: 22Jan2021, for COVID-19 immunization, reaction: "None from vaccines except sore arm"; Pfizer / Biontech COVID-19 vaccine (DOSE 2, SINGLE, Lot number: EL9266), administration date: 02Feb2021, for COVID-19 immunization, reaction: "None from vaccines except sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "recovered" (2022), described as "None from vaccines except sore arm". Therapeutic measures were not taken as a result of pain in extremity.
Initial unsolicited misuse report received from a physician ion 04-Nov-2015. This case involves an 29-year-old female patient who was vaccinated with an intramuscular first dose of Imovax (batch number: K1057, K1729, site of administration was not reported) and an intramuscular first dose of Imogam (batch number: L1050-2, expiry date: 23-Jan-2017 and site of administration was not reported) on 15-Jul-2015. The patient was possibly vaccinated with RABAVERT on an unspecified date. It was reported that the patient had no illness at the time of vaccination, no known allergies and no medical conditions. Patient had no vaccination within 4 weeks of vaccination and concomitant medications were not reported. On 30-Jul-2015, 15 days after vaccination, the patient experienced daily headaches in parietal area. The patient was noncompliant with receiving the post exposure vaccines, had received 3 after receiving the second vaccine. Patient required an ER visit on 15-Jul-2015. It was a case of inappropriate schedule of vaccine administered. Laboratory investigation include blood tests which was within normal limits and did not had any studies to evaluate the headaches. It was reported that corrective treatment include over the counter medications to relieve headaches. The outcome of the event was reported as not recovered. Documents held by sender: none.
8 days after vaccination, patient experienced new erythematous patch at the injection site which was painful, swollen, warm, and pruritic. Also had generalized body aches and fatigue x 10 days. This eventually resolved on its own.
Increased heart rate with walking, increased respiratory rate with walking in the morning. This progressed to throughout the day over the next week. Hospitalized for these symptoms, sweating, and dizziness on 03/25/21-03/27/21. High lactate levels  were also present. Multiple tests for cardiac workup have been negative except for high heart rate and respiratory rate with sitting, standing, and walking but these will return to normal within a few minutes. Oxygen saturation has also been dropping as low as 74% for a few minutes after lying back down. Diagnosis of POTS was made but continued work up in progress for oxygen saturation dropping.
Noticed large red spot (approx. 2" X 3" at Injection site on right arm today, 02-27-2021. Some soreness  still at the injection site. Have never had any reactions like this before when have taken Immunizations  shots.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown gender and age. No relevant medical history of the patients was reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ orally (lot number, strength, dose and frequency were not reported). There were no concomitant medications reported. No adverse effect was reported. It was unspecified if the patients had sought any medical attention. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past.  It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.
Bad cramping in left leg, drop foot in left foot, lost all muscle mass on left side of body. Went from perfect health to dianosed with ALS or Lou Gehrig disease after the 2nd shot.
pt recvd MMR vax on 28MAY91 following vax pt devel rash; no further details were provided;
Myalgia, Arthralgia, Fever, HYPERtension, Tachycardia, Fatigue Narrative:  Other Relevant History:
Patient vaccinated against COVID-19; received COVID-19 Janssen vaccine on 3/10/2021.   Patient developed symptoms last week of March.  Called Provider with symptoms and then presented to the hospital (admitted on 4/1/2021).   Tested for COVID and found to be positive.  4/1/2021.  Patient declined, admitted to ICU on 4/3/2021.  Patient died on 4/4/2021.    Chief Complaint: HPI: Patient is a 79 y.o. yr. old female who presents today for COUGH (has had cough for a little over a week) and FEVER (on and off for about a week)Patient was seen due to feeling ill for over week.  Patient states that she was trying to fight it on her own but symptoms have been progressing.  Patient has felt feverish no known fevers.  Has had a persistent now worsening cough.  Patient is feeling very tired and weak due to being sick for over week.  Patient does live alone. Patient is coughing which is productive with sputum.   Patient is eating and drinking well.  No N/V/d.  No loss of taste or smell.   No recent ill exposure.;  Has had covid vaccine.  Patient did get the Johnson and Johnson vaccine over a month ago. Patient is feeling very fatigue; Having feverish/chills.   Patient is taking OTC nightquil which is no longer helping. Patient does see oncologist for her CLL.  DISCHARGE DIAGNOSIS: 1. Deceased 2. COVID-19 with hypoxia 3. Asthma 4. Anemia     DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: Patient is a 79 year old female who was admitted on 04/01/2021 for COVID-19 pneumonia with complications of hypoxia.  Patient's symptoms of cough and shortness of breath have been present for approximately 2 weeks.  It was noted that 1 month ago she did receive the Johnson & Johnson vaccine.  Upon admission patient was treated with azithromycin, Rocephin to cover for secondary bacterial infection.  She was not a candidate for remdesivir due to the length of her symptoms.  She was started on  Decadron, as well as gentle fluids due to tachycardia for approximately 12 hours.  During the night of 4/2-4/3 patient progressively declined requiring more oxygen she was transferred to the intensive care unit.  Patient was a do not resuscitate continued decline and after exacerbating all treatment options patient was switched to comfort care earlier this evening.  Pronounced dead at 6:45 a.m.
patient has Parkinson's' and noticed worsening symptoms the day after including difficulty walking and shuffling of feet.
Information has been received from a registered nurse concerning a 17 year old female with a history of an orbital fracture, knee operation, fainting at needles, and no drug allergies, who on 21-JUN-2007 was vaccinated with a first dose of Gardasil.  The patient was vaccinated with a second dose of Gardasil on an unspecified date.  On 21-JAN-2008 the patient was vaccinated intramuscularly with a 0.5 mL third dose of Gardasil (Lot# 659437/1266U).  There was no concomitant medication.  On 21-JAN-2008 the patient had a seizure in the office.  The patient was administered the vaccine in a lying position and was observed for 10 minutes.  When the patient stood to leave, she felt dizzy and was seated back on the exam table.  At that time, the patient fell back onto the table, drew up her arms, clinched her hands in towards her chest and her legs became stiff.  The nurse reported that the patient had demonstrated "dolls eyes".  The patient's pupils were dilated 7-8mm.  The patient was having seizure movements, but not thrashing about.  The patient was unresponsive, but did not lose complete consciousness.  The seizure lasted 3-5 minutes.  After the seizure the patient was "pasty colored" and sweating.  At this time the patient was able to speak, but could not "track" (she could follow the person that was speaking to her).  At this time the patient's breathing was labored but she was not in distress.  The nurse called EMS and the patient was taken to the emergency room for evaluation.  While the patient was being assisted to the litter she again became pale and fell onto the litter.  The patient was not able to follow directions given to her by the EMS.  The patient's head was turned in the opposite direction of people speaking to her.  No laboratory diagnostic studies were performed.  The patient was released home with her mom (a scrub nurse at the hospital she was evaluated at).  The nurse reported that the mother told her that the patient had taken a nap on the previous afternoon and when she woke up her mother allowed her to compete in a basketball game.  The patient recovered on 21-JAN-2008.  No product quality complaint was involved.  Upon internal review the seizure/seizure movements was considered to be an other important medical event.  Additional information has been requested.
BAD STOMACH PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad stomach pain was not reported. This report was non-serious.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 7:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 06-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route of administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports received from the same source. Additional information has been requested.
SHORTNESS OF BREATH-A LITTLE; CHEST PAIN; CHILLS; NAUSEA; FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a 23 year old male. 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: Unk) dose was not reported, administered on 06-JUL-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the subject experienced shortness of breath-a little. On 07-JUL-2021, the subject experienced chest pain. On 07-JUL-2021, the subject experienced chills. On 07-JUL-2021, the subject experienced nausea. On 07-JUL-2021, the subject experienced fever. On 07-JUL-2021, the subject experienced muscle pain. On 08-JUL-2021, Laboratory data included: Chest X-ray (NR: not provided) Not reported, and EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, chills, muscle pain, shortness of breath-a little, and chest pain. This report was non-serious.