chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On 21-NOV-2017, the patient was inadvertently vaccinated with a dose of PROQUAD Lot # N012491, expiration date on 17-OCT-2018, for prophylaxis (strength and route of administration were not reported), instead of an intended dose of M-M-R II for prophylaxis (strength, dose, route, Lot # and expiration date were not reported). The PROQUAD vaccine was administered simultaneously with an intended dose of VARIVAX for prophylaxis (strength, route, Lot # and expiration date were not reported). The nurse confirmed that she did not confuse PROQUAD with M-M-R II but simply grabbed the wrong vaccine and did not realize her error until she went to document in the patient's chart. No adverse effects were reported. The dose of M-M-R II was not administered.
Hives warm to the touch surrounding injection site on right thigh. Noticed 30 minutes after injection.
pt recvd vax 8NOV93 & 15NOV93 called MD stated pt had devel pus @ inject site; lt thigh red, swollen, warm; drainage yellow @ home; taken to hosp;
Dryness and swelling of tongue and cheeks; Swelling of tongue and cheeks; Swelling of tongue and cheeks; Tongue is also "irritated" by certain foods; Diarrhea; Achiness; Nausea; Headaches; Fever; Fatigue; Hoarseness; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Achiness), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks) and SWELLING FACE (Swelling of tongue and cheeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial cancer, Uterine cancer, Ovarian cancer and Urinary incontinence. Concurrent medical conditions included Hypertension and Weight loss (Lost approximately 15 pounds since September 2020). Concomitant products included LISINOPRIL for Blood pressure high, LENVATINIB MESILATE (LENVIMA) from 19-Mar-2021 to an unknown date for an unknown indication.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Achiness), NAUSEA (Nausea), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue). On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and DYSPHONIA (Hoarseness). At the time of the report, DIARRHOEA (Diarrhea), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and NAUSEA (Nausea) had not resolved and PAIN (Achiness), DYSPHONIA (Hoarseness), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) Elevated but stable.         The patient was scheduled to receive their Keytruda vaccine on 09 Apr 2021 but rescheduled it to 19 Apr 2021.  The patient reported that they still had issues with their mouth and their blood pressure was still elevated but stable.  Patient's Relevant Medical history also included Keytruda infusions.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 as NNI-email without source document attached On 27-May-2021: Follow up received on 27-May-2021 as new events added
Information has been received from a consumer concerning her 17 year old daughter with sulfonamide allergy and allergic reaction to CECLOR family of drugs who in September 2007, was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On the same date, the patient felt like fainting 15 minutes after her second dose. She also missed the third dose. The consumer stated that her daughter was also diagnosed with polycystic ovary syndrome (PCOS) after received her second dose of GARDASIL. Additional information has been requested.
Arm swelling; Arm hardness; felt sick to my stomach; nausea; injection site itchiness; injection site rash; injection site bumps; injection site red lesion(COVID Arm).; Body aches; FEVER; CHILLS; BACKACHE; SKIN ACHE; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness) and ABDOMINAL DISCOMFORT (felt sick to my stomach) in a 75-year-old female 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS). On 15-Feb-2021, the patient experienced MYALGIA (Body aches). On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps) and VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).). On 21-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach) and NAUSEA (nausea). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps), VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS) was resolving and PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach), MYALGIA (Body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant products were provided. Ice pack is the other treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup information received on 25-may-2021, No new information
Contact with and (suspected) exposure to covid-19; Suspected COVID-19 virus infection; COVID 19 MAB Infusion Navigator Initial Patient Assessment; Ordering Prescriber has completed required FDA EUA elements. COVID-19 Positive Result Date (and on chart/file): 05/19/2021; Start of Symptoms Date:  05/18/2021;  Body mass index (BMI) ?35; Chronic kidney disease; Diabetes; Immunosuppressive disease ? 65 years of age ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease
Fever/chills, nausea/vomiting, diarrhea, body aches
Just days after receiving their final round of shots, both my children became very ill.  I had put off getting them the shots as long as I could, but we were forced to get them because the children's insurance was revoked until we got them caught up on these shots.  Anyway, about 3 days after getting the shots, both children had high fevers, loss of appetite, chills, and breathing problems.  My son, who is older, took better to the antibiotics that were given to them by their pediatrician.  He started to get better, but patient's condition got worse.  Their mother rushed her to the emergency room where she had a febrile seizure and stopped breathing.  The emergency room team was able to revive her and get her breathing again.  We stayed overnight in the hospital, but then in the morning we received no answers as to what was going on, and the doctor at the hospital gave us nothing to help and our daughter was released.  The very next day she still had a high fever, breathing trouble and matted eyes, so we took her to her pediatrician's office, where we were told to get her to the hospital immediately and the doctor showed disbelief that she was released the way she was.  Under the doctor's recommendation, we took her to the new pediatric unit at the Hospital.  We stayed there for 5 days with our daughter getting poked and prodded, IV's antibiotics, breathing treatments, tests and more tests.  The doctor told us that she had developed a viral and bacterial upper respiratory infection.  Any time I tried to bring up the shots, I was scoffed at, and viewed as an insane person.  Both children had, up until that point, been very healthy and had never had more than a little cold or ear infection.  I believe that if we hadn't gotten our daughter back to the hospital when we did, she would have died.  I was scared for her life from the first night in the emergency room and especially after we were turned away with no explanations and no prescription of anything to help her infection.  I am very thankful for the people who actually cared for our daughter and not for their profit margin.
Patient felt nauseated, shaky and very tired for two days. Her arm at injection site was red, hot and swollen.   She took Tylenol and slept. The arm swelling went down after three days.
pneumonia; neurological problems; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. Information regarding the pt's concurrent conditions, medical history and concomitant medications was not provided.  On an unknown date, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On an unspecified, after received zoster vaccine live(ZOSTAVAX) the pt suffered from pneumonia and serious neurological problems. As a result of these symptoms, the pt was seen and treated by medical providers. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had sustained severe and permanent personal injuries, including but not limited to: serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also had suffered and incurred damages, including medical related expenses, the loss of accumulations; and other economic and non-economic damages as a result of these injuries.  By the time of this report, the pt had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
At the time of injection, I heard a crunching sound and instant intense pain.  The injection site was very high and may have been injected into the shoulder joint.  I did not experience this with the 1st dose. The pain continued non-stop the same day Sunday, Monday , Tuesday at the time of this report. The pain is accompanied by limited mobility and functionality, i.e. can't move arm without intense pain and cannot lift arm.
Fever, Aching bones, Sore skin, HA, Blurry vision, Severe coughing,Very tired, Ttightness in chest, Large volume green phlem, Sweating, chills, Runny nose and eyes. Most symptoms subsided in 7 days. Coughing continues into 3rd week
This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (K021152 Expiration date: 02-JAN-2016). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
High pitched screaming after Prevnar for 16 hours after injection. Only received Prevnar that day. No other IMM's administered on that date.
patient complained of difficulty swallowing and dizziness and was placed on a monitor.  VS on 01/26/21 at 1515: BP= 144/81, Temp= 35.8 C, RR= 24, HR= 102; at 1518: dizziness had resolved: BP= 124/81, Temp= 35.8 C, RR= 20, HR= 198, O2 Sats RA= 100%; at 1521: patient states still has difficulty breathing, patient encouraged to do slow deep breathing, VS: BP= 137/84,  RR= 20, HR= 84, O2 Sats RA= 99%.  At 1524: VS: BP= 123/88, RR= 20, HR= 98, O2 Sats RA= 100%.  At 1527 VS: BP= 121/77, RR= 20, HR= 91, O2 Sats RA= 99%.  At 1531 patient continues to complain of difficulty swallowing, patient encouraged to take slow deep breathes, VS: BP= 125/78, RR= 18, HR= 90, O2 Sats RA= 94%.  At 1536, patients states swallowing is better and said "maybe my throat is dry," VS: VS: BP= 133/82, RR= 18, HR= 94, O2 Sats RA= 100%.  At 1541 patient starts to complain of a headache, VS: BP= 128/86, RR= 18, HR= 94, O2 Sats RA= 94%.  At 1546 patient is stable and is able to ambulate VS: BP= 123/84, RR= 18, HR= 94, O2 Sats RA= 99%
Initial case received on 26 January 2010 from a healthcare provider.  A 29 year old male patient received an intramuscular left deltoid injection of IMOVAX Rabies (lot number D0869-1) at approximately 1:30 P.M. on 19 January 2010 (The narrative on the report states this was the first dose, but "Number of previous doses" was marked as 1). The patient also received within the previous four weeks, an intramuscular right deltoid injection of H1N1 (lot number UP001AA), a subcutaneous right arm injection of YF VAX (lot number UF627AA) and an intramuscular left deltoid injection of FLUZONE (lot number U3254EA) on 13 January 2010.  On 20 January 2010 at approximately 2:00 P.M. the patient experienced abdominal pain rated 2 on a scale of 10 and lasted 5 hours.  Follow-up information was received 19 February 2010 from a health care professional.  The reporter confirmed the event occurred after the patient had received their first dose of IMOVAX Rabies vaccine, lot number D0869-1.  The patient completed the IMOVAX Rabies series and did not experience any additional adverse events.
Pt c/o pain in elbows when he tries to move them, especially the left arm. It started two days after the shots. He says it feels like his tendons and ligaments are really sore. They are slightly sore to the touch but very sore when he tries to move them, he feels like his range of motion is limited. There is possibly slight swelling at the elbow on the left arm but none on the right arm.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Product was administered past the expiration date/Expired vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion/vaccine was above 46 F for 10 minutes while stored in the fridge) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 21-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Product was administered past the expiration date/Expired vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion/vaccine was above 46 F for 10 minutes while stored in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Product was administered past the expiration date/Expired vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (had an excursion/vaccine was above 46 F for 10 minutes while stored in the fridge) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. An overview of temperatures while stored in the fridge was provided as Min 36.6 F  Max 47.3 F Average 38.3 F.. No treatment information was provided by the reporter.
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 7th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407
Fatigue, fever, muscle cramps/aches, headache, stomach pains, dizziness, flushed cheeks Treatment : Advil every 6 hours for 2 days, tested negative for flu and strep throat.
Second adult dose of Hepatitis A vaccine was given 16 days too soon.  Rehab facility is in rural area, was unable to connect to internet or use cell phone to call my staff at County Health and Human Services, Immunizations clinic to verify date of last dose. No adverse events reported.
1.  Fatigue - Unable to stay awake for a complete work day 8am-5pm since around June 7th 2.  Legs go numb, burn and tingle from knees to toes while standing or walking.  Lasts for approx 1 hour and occurs several times per day.  Getting slightly better but not resolved.  Have seen Dr and Chiropractor  3.  Arms go numb from shoulder to finger tips.  Much less severe than legs.  Occurs about daily for about 15 minutes. 4. After catheterization on 6/18/21 had blood in urine and blood clots in bladder from 6/21 thru 7/18.  Have needed to occasionally catheterize (about 1/ quarter) for several years due to chronic Lyme and chronic prostatitis.  Have never had this reaction before.
vaccinated on 3/6/03 On the evening of 3/22/03 developed temperature, rash and subsequently a total of 143 spots on whole body. On 3/26/03 did a DFA which came back positive for varicella zoster virus antigen
I was feeling really tired and couldn't focus on anything. I had developed a cough and night sweats, so I tested myself for COVID-19 and tested positive on August 31, 2022 and was prescribed PAXLOVID. My symptoms went away after about a week and I had tested negative but then I started getting a cough around September 13,2022 and tested positive for COVID-19 again. I felt worse the second time around and had to call my doctor for more meds. I still have to use a inhaler because I start wheezing.
Fatigue, scratchy throat, headache, sinus congestion, cough, mild nausea.
fully vaccinated employee tested positive 11/2/21 Pfizer  1st dose 12/12/21 2nd dose 1/8/21  Booster 10/1/21
pt recvd vax 7PM did not wait the 20 mins observation time; 10-15 mins post inject exp SOB, hives, abdo pain; was treated w/Epi, Solumedrol, & DPH; f/u w/MD again 25OCT & no further sx noted;
This spontaneous report was received from a pharmacy technician concerning an unspecified number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, frequency and route were not reported) lot # M013156 with expiration date of 15-OCT-2017, for prophylaxis. The temperature of the PNEUMOVAX23 was 47°F for a time frame of 15 minutes. Also, a prior temperature excursion occurred and the temperature was 50°F for a time frame of 12 hours. No adverse effects were reported. The excursions were called due to data logger. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 30-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 ((lot # M008766 (not valid), expiry date: 15-OCT-2017) (route: intramuscular). On the same day, the patient had received another dose of PNEUMOVAX 23 (inappropriate schedule of vaccine administered). No side effects reported. The outcome of the events was unknown. Additional information has been requested.
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Multiforme rash over approximately 50% of body. No fevers, no spots, no cough.
One day after shot, rash started in the arm flu vaccine was given (L). Now rash on chest and itchy. There is a raised area at the site of the flu shot.
Starting getting dizzy and lightheaded 5 minutes after receiving shot.  Drove to my office, arrive 9:55.  From approximately 10AM-1:30PM have no memory of anything I did or said.  I remember driving back to my office after doctor visit, next thing it was 1:30 in the afternoon and I was home.  Office staff stated I layed down in my vehicle, stating I did not feel well.  They said my eyes were a little hazy, similar to when I get a migraine headache, but talked and carried on normally. Slept most the day.
Admit for COVID with possible bacterial pneumonia. Fully vaccinated, not sure when.Treated w/ O2, remdesivir, steroids, cefepime, vanc, tociluzimab. Still admitted at time of review 7/29, on 6L O2.
A 20 year old female pt received her first dose of RabAvert for preexposure series into left deltoid on 02Dec03. Approx 1-1.5 hours later, she c/o nausea, lethargy, tingling left arm, left side of chest, numbness left arm which lasted about 3 hours (particularly nausea). Observation during this time found pt to be in no acute distress (NAD) and neuro exam to be within normal limits. The pt left the clinic with only mild paraesthesia left arm. Additional information received on 03Dec03: The pt was contacted by her health care provider on 03Dec03. The pt stated she had completely recovered.
Vaccine administered came from vial that was kept in fridge for longer than manufacturer recommended storage date.  Patient did not return our multiple calls to inform them of the expire vaccine that they received. The patient did not call back in any capacity to complain about any adverse events. The manufacture informed us via written statement that patients "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration". Revaccination was not advised.