chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 02 September 2014. A 26 year-old male subject with no past medical history reported was found with Encephalitis, myelitis and encephalomyelitis 9 days after he had received an injection of ACAM2000 (lot number and site of administration not reported) on 25 February 2014. He had previously received the following vaccines on 18 February 2014: Anthrax vaccine and Typhoid, ViCPs vaccine (manufacturers, lot numbers, routes and sites of administration not reported). On 06 March 2014, he was diagnosed with Encephalitis, myelitis and encephalomyelitis. No laboratory test results were provided. It was not reported whether the patient had received any corrective treatment. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Additional information will be requested from the investigator.
allergic reaction; Initial information was received on 21-Jun-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 13 years old female patient who had an allergic reaction (hypersensitivity) after receiving TETANUS TOXOID.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergy to horse serum   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of TETANUS TOXOID.  The caller reported she had an allergy to horse serum. As per her doctor she could receive a tetanus vaccine as long as it did not have horse serum, which she thought they stopped using  No laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Headache, Myalgia, Fever, body aches, fever, headache, fatigue, runny nose Narrative: Day 1 through 9 - body aches, fever, headache, fatigue, runny nose, eye pain; states get fever when has flu shots
Anaphylaxis within 15 minutes.   Throat tightened wheezing began given Benadryl at clinic then taken to ER downstair at Hospital.   Given more benadryl, then epinephrine, Decadron, then breathing treatment. once undercontrol sent home and then recommended seen by own doctor.  I saw doctor on the 21st.
This case was reported by a consumer via call center representative and described the occurrence of breathing arrested in a female patient who received RABAVERT for prophylaxis. The patient's past medical history included animal bite. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 2nd dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced breathing arrested (serious criteria GSK medically significant), hives, difficulty breathing, neurological disorder nos, twitching facial, burning foot, low blood pressure, burning in eyes, burn of unspecified degree of foot and vaccine administered at inappropriate site. On an unknown date, the outcome of the breathing arrested and difficulty breathing were recovered/resolved and the outcome of the hives was not recovered/not resolved and the outcome of the neurological disorder nos, twitching facial, burning foot, low blood pressure, burning in eyes, burn of unspecified degree of foot and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the breathing arrested, hives, difficulty breathing, neurological disorder nos, twitching facial, burning foot, low blood pressure, burning in eyes, burn of unspecified degree of foot and vaccine administered at inappropriate site to be related to RABAVERT. Additional details were reported as follows: The patient was tall and had thick thighs. The patient recently experienced what she thought was a bat bite and received two injections of RABAVERT at the emergency room, both administered in her thigh. After receiving 2nd shot, the patient had breathing problems and she stopped breathing for a period of time. She also had very low blood pressure and burning eyes and had to be kept at the emergency room for several hours for observation. The patient went to the emergency room at approximately 7 PM and went home around 4 AM. The patient developed hives from head to toe and still had the hives. She also had neurological problems for a couple weeks after the vaccine. When she smiled her face would twitch, and the bottom of her feet burned. The patient was not sure all of the problems were related to RABAVERT. Around the same time this was happening, her daughter had strep throat and was later diagnosed with scarlet fever and had a rash similar the reporter's. Strep throat and other illnesses were going through her household. Due to the fact that the injection was given in her thigh, the emergency room recommended she get a titer to check if the vaccine was effective. The titer came back with an antibody lever greater than or equal to 0.5 and said it was acceptable level. This case has been linked with case US2018GSK121404 (same patient for 1st dose), reported by the same reporter. The reporter said that she had reported these adverse events previously but duplicate case could not be found. Lab Comments: Lab test for rabies antibodies was done on an unknown date and the antibody titre was found to be greater than or equal to 5 and it was acceptable level.
pt placed in home hospice with diagnosis of COVID pneumonia; pt's condition was worsening - increasing SOB, on O2 supplementation (NRB), dyspnea with rest, decreased po intake; DNR; per death certificate, pt died at home
Pt. jerked arm while giving SHINGRIX, resulted in partial administration of vaccine and had to be re-administered after 7 days. Patient also felt dizzy afterwards and suffered near-syncopal event.
19 weeks Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (19 weeks Pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 19-Aug-2020 and the estimated date of delivery was 01-Jun-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (19 weeks Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (19 weeks Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
wheezing upper respiratory; high blood pressure; bronchitis; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 67-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0153) via intramuscular route of administration (age at vaccination 67-year) in Left Arm on 14Apr2021 02:00 PM as dose 2, single for COVID-19 immunization. It was reported that the patient previously received the first dose of BNT162B2 (Lot number: ER8732) on 24Mar2021 in Left shoulder for COVID-19 immunization. Medical history included Illness: No illness at time of vaccine; Sometimes wheezing from change of seazures- pollen had very mild here and there but became chronic after vaccines for COVID-19 from an unknown date and unknown if ongoing No illness at time of vaccine. Concomitant medication included azithromycin taken for upper respiratory tract infection, bronchitis from 15Apr2021 and ongoing. On 15Apr2021 the patient experienced wheezing upper respiratory, high blood pressure. The patient underwent lab tests and procedures which included chest x-ray (Check for clots blood pressure): negative on 19Apr2021; computerised tomogram: check for clots foot swollen and previous knee fracture- swelling more-checked for clots 03May2021; COVID-19 (Wheezing upper respiratory Cushing- high blood pressure): negative on 19Apr2021; ultrasound scan (Check for clots blood pressure high): negative on 20Apr2021. The events were reported as serious (medically significant). AE required to visit physician office. Therapeutic measures were taken as a result of wheezing upper respiratory, high blood pressure. The clinical outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Information has been received from a physician concerning a 13 or 14 year old female who in January 2008, was vaccinated with the first dose of GARDASIL (Lot number not provided).  In January 2008, the patient developed pain in right lower quadrant.  The patient went to the ER but was not admitted.  The series of doses was discontinued.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
CDC Reports: 2 mo infant received DTP/OPV on 12OCT89 and died 8NOV89.
Patient presented to the ED on 3/30/21. Patient also presented to the ED and was subsequently hospitalized on 4/1/21. On 4/5/21 he had an ED visit, and on 4/9/21 patient presented to the ED and was subsequently hospitalized. These visits are within 6 weeks of patient receiving COVID vaccination.
On 10-9-12, patient called to say that he is still experiencing pain in arm when he moves it. He is going to Doctor on Friday 10/12/12 and will call us with what doctor says. MD put on anti-inflammatory and will recheck in 2 weeks. May need MRI. Patient states getting worse. Patient had tattoo on arm where shot administered.
Patient said that he had not received a covid vaccine previously. After we contacted him in subsequent days to solve insurance billing issues, he reported that he received the J&J vaccine on 3/8/21
This spontaneous report as received from a physician refers to an 18 month old male patient. The patient's pertinent medical history and drug reaction or allergies were not reported. On 24-MAR-2016 at 11:12 a.m., the patient was inadvertently vaccinated with the first dose of GARDASIL (lot # L040459 with expiry date 06-APR-2017), intramuscularly in the right thigh. Concomitant vaccines included the fourth dose of PEDIARIX (lot # 924JA) and the first dose of hepatitis A virus vaccine inactivated; both administered intramuscularly in the left thighs on 24-MAR-2016 at 11:12 a.m. There was no illness at the time of vaccination. No relevant diagnostic tests and laboratory data were performed. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.
This spontaneous report received from a physician refers to a 68 year old female patient enrolled in a Market Research. Concurrent or medical conditions were not reported. Spring 2013, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. Summer 2014, the patient developed shingles after receiving ZOSTAVAX. The patient recovered from shingles in 2014 (14-21 days after onset). The reporter physician considered shingles to be related to ZOSTAVAX. Additional information has been requested.
mom states pt started crying approx 11AM; states would nurse @ times, did console to holding & did stop crying to fall asleep for 5-10mins @ times would wake crying; stopped crying approx 4PM (total 5 hrs) p/crying; irritable;
Patient complained of debilitating muscle pain in both arms and groin area. He used to be an avid swimmer and can't swim anymore. Used to bench press 50 lbs or more and cannot even lift 25 lbs now. This started 2 days after receiving flu shot.
Six days post vax pt developed chickenpox that consisted of greater than 50 lesions all over the body. Pt maximum temperature was 101.9F. Pt was not exposed to natural chickenpox.  One week after onset the pt recovered.
This spontaneous report as received from a health professional (nurse) refers to an unspecified number of patients of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On an unknown date these patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K018143, expiry date: 10-APR-2016). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two reports received from the same source (MARRS # 1507USA007754). Additional information has been requested.
Weakness, dizziness, joint aches, chills, headache.  Problem started at night, 12 hours of sleep made symptoms disappear.  No health professionals consulted.
Pt was given diluent only without the medication.  Had to restick the patient a second time to give the vaccine correctly.
Within minutes of the injection I felt very dizzy with associated palpitations.  The triage RN took my BP 160/80 HR 110.  The sensation quickly subsided and i left the triage area within 10 minutes.   Over the course of the next 3 hours that same sensation would come and go every 10-15 mins, again lasting a short time with return to normal,  I would feel very dizzy with palpitations lasting about 30secs-1min and then it would subside.  At one point I had a metallic taste in my mouth, another time i felt nauseous.  My coworker stated I was pale.  By 12:30pm that day the sensations stopped and I just felt very tired the rest of the day.   By the following day I felt completely back to normal.
right arm swollen; chemical taste in mouth; lymph nodes on my right side swollen; Fever; muscle aches; migraine; The right side of my neck got sore; The right side of my neck got swollen; Longer than 35 days between Covid-19 Moderna vaccine; extremely sick; fatigued; Myalgia; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia) and MYALGIA (muscle aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued) and MYALGIA (Myalgia). On 21-Feb-2021, the patient experienced MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore) and SWELLING (The right side of my neck got swollen). On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth), LYMPHADENOPATHY (lymph nodes on my right side swollen) and PYREXIA (Fever). On 20-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine) had resolved. On 01-Mar-2021, ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia), MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore), SWELLING (The right side of my neck got swollen), PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth) and LYMPHADENOPATHY (lymph nodes on my right side swollen) had resolved. At the time of the report, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided. At the hospital, patient was told that the event chemical taste in mouth was due to the vaccine.
Information has been received from a consumer concerning her 15 year old daughter who in July 2009, was vaccinated with a dose of GARDASIL (lot number not reported). Subsequently the patient experienced an injection site reaction after vaccination. Therapy with GARDASIL was discontinued. The symptom was improved. It was unknown if medical attention was sought. At the time of the report, the outcome of the patient was not reported. No further information is available.
Prolonged elevated heart rate - 95-100 BPM (+30 from baseline) Lightheadedness Chills Extreme fatigue
Took seasonal Flu shot 10/26/09 @ 3:22 pm 10/27/09 at 11:30 am woke up with aching pain in legs & all over. Legs worse. States can hardly walk. Did report to work.
Client received High Dose Flu vaccine 10/11/11. States later that night started with muscle pain in all extremities. Could not drive for 4 days still has muscle pain & swelling on hands & feet at night - saw private MD 10/12 & 10/17 preformed blood test & gave pain medication.
Diabetes diagnosis based on bloodwork, very high A1C about 2 years after having a normal A1C, do not have lab work from 2020, but unusual to see such extreme change so suddenly, no COVID infection
This spontaneous report was received from a medical assistant regarding a 18 year old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 24-JAN-2019, the patient received first dose of adult formulation of VAQTA 50/0.1 u/ml, lot # R006341 with expiry date 21-APR-2019 for prophylaxis, instead of pediatric formulation of VAQTA. No adverse effects were reported. No product quality complaint was present.
pt recvd vax & fainted; gasped for breath; turned very pale & had blue infing around her mouth;
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unspecified dates, since 18-DEC-2014, the doses of ROTATEQ that underwent a temperature excursion, were administered to unspecified patients (default route; oral, dose, lot numbers and expiration dates were not provided) No adverse effects have been reported. This is one of several reports from the same source. Additional information has been requested.
Woke up with headache and sore throat, developed more lethargy/fatigue. Telehealth appt with dr on 2/10, said to rest. Stayed home from school, returned to school 2/21/23
Nausea, vomiting and diarrhea soon after administration of the vaccine. Previously was feeling fine.
Pt recvd Hep B vax 17JUL91 & approx 24 hrs post vax, pt devel a generalized rash; Pt was placed on therapy w/DPH;the rash lasted 5 days; @ time of report pt had recovered;
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative, notes: Covid rebound positive test after negative test a few days earlier; Positive, notes: Covid rebound positive test after negative test a few days earlier. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Caller is an HCP reporting a patient missed her 2nd dose of GARDASIL 9 that was due in July and came in today to receive it. The patient, however, is now 46 years old. No additional clarifying statements or details were provided. HCP declined permiss; No additional AE; This spontaneous report was received from another reporter and refers to a 46-year-old female. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date (when the patient was 46-year-old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported) (inappropriate age at vaccine administration). No adverse events were reported.
Within one hour after vaccine given, child had erythematous morbilliform rash to torso and faces with no breathing issues. Appeared sleepy at first. He was given 2 tsp BENADRYL with rash almost completely resolved within 20 minutes of the BENASRYL much improved temperament and after dose of BENADRYL.
About 45 minutes after receiving vaccine the patient was at home and while reaching into the refrigerator he got dizzy and passed out. Patients wife said he lost consciousness for a few seconds.  Patient said he felt dizzy and tired for several minutes afterward and did not feel completely normal for 2 days afterwards.
Rash and swelling at site of administration. Loss of appetite for days afterward. Sleepiness and trouble sleeping. Moderate fever night after vaccination.
Patient experienced red, raised, itchy area 14 cm, warm to touch, forming blisters. Treated for possible cellulitis / cephalexin 500mg 1 cap q 6 hrs.
Information has been received from a physician concerning a 11 year white female student on 22FEB2001, was vaccinated in the left arm with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The physician reported that on 27MAY2003, the patient developed varicella disease. It was unknown if medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
The next day after receiving my vaccination, I felt fatigued. I wasn't concerned because I felt fatigued after all my vaccinations. However, this continued and got worse over the next week. I felt sluggish. My body was achy. That continued for a couple of months. I went to the doctor. She did routine bloodwork and checked my thyroid. My T4 was a little elevated and my iron was a little low. The doctor prescribed iron. I continue to feel fatigue most of the time. The body aches have gotten better, but the fatigue is ongoing.
Fever, red area, pain, itch. Cefadroxil 500 mg one BID, Acetaminophen 500mg one every 4 hours csn, Hydroxyzine Hcl 25mg one every 6 hours.