chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started on 12/16 with a mild cough and ache, within 1 day it became severe aching and a lot of coughing. Low grade fever, congestion. Currently I'm on day 12 and have extreme fatigue, some coughing and congestion. I took PAXLOVID and started it on my day 4 and took it for 5 days.
Four days post vax, mom reported the pt was fussy and spitting up. Reported wheezing. Pt was seen by physician six days post vax who stated symptoms were due to stomach problems and treated with Prevacid.
This spontaneous report as received from a 79 year old female patient (reporting on herself). On 01-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose, frequency and route not reported). Concomitant therapy was not reported. It was reported that 2 weeks after she had the vaccine, on 15-APR-2013, the patient had shingles. At the time of the report the patient's outcome was unknown. Additional information has been requested.
She had an enlarged lymph node on her neck on the side of the injection after her first vaccine. It became larger for the first 3 days after the 2nd injection and then went back down to the size it was prior to the 2nd injection.
Information has been received from a physician concerning a 14 year old female patient who on 10-APR-2009 was vaccinated with the first dose of GARDASIL in the left deltoid. The patient also received a PPD test the same day. Subsequently, the patient experienced burning feet and hands after the vaccination with GARDASIL. The experience was not immediate, but once she got home, for the next 48 hours, the patient had to have her hands and feet in buckets of ice water. She had sensation of burning. There was no swelling and there was no emergency room (ER) visit. It was reported that it seemed to have a spontaneous onset and a spontaneous recovery. There was no preventive of serious criteria needed. The doctor determined that the patient was allergic to GARDASIL and would not administer any more doses. At the time of the report, the patient recovered on an unspecified date. It was noted that the patient was also on ADDERALL, but was on ADDERALL holiday because of spring break. Follow-up information has been received from a physician concerning a 14 year old female patient with no illness at time of vaccination and with no pre-existing allergies who on 10-APR-2009 at 3:00 PM was vaccinated with the first dose of GARDASIL IM in the left deltoid. At 8:00 PM on 10-APR-2009 the patient experienced burning and itching of feet and hands to the point of putting them in ice water. The events lasted for 2 days. Medical attention was not sought. No laboratory diagnostic test was taken. On 12-APR-2009, the patient recovered. The reporting physician felt that burning and itching of feet and hands and allergy to GARDASIL were related to therapy with GARDASIL. Additional information is not expected.
12 Y 4 M old male with a history of chest pain that started two days ago on Monday. On 7/11 night, he didn't feel well felt nauseous. He was able to sleep but had chest pain the following morning that improved after he vomited. The chest pain is midsternal and feels pressure-like. It lasted a few hours. He swam on 7/12 without problems (at a swim club) for an hour. He had his second dose of COVID-19 vaccine on Saturday 7/10/21. There has not been any fevers. Elevated troponin and CRP with recent COVID-19 vaccine, suspicious for post-vaccine myocarditis. He is hemodynamically stable with normal vitals and no evidence of ventricular ectopy or depressed left ventricular function. His troponin peaked at 11.05 and trended down, but his most recent value is slightly up at 8.2 from 7.6. Recommended continuing to trend the troponins for now (if they show a downward trend then twice daily is adequate, unless he develops chest pain). At this time, IVIG is held unless he becomes unstable or  the troponins trend upward .
Fever for 2 days then rash starting on neck & groin area and spreading; Mother describes as flat, red blotches.
PATIENT FAINTED IMMEDIATELY FOLLOWING THE VACCINE ADMINISTRATION. LAID PATIENT FLAT ON THE FLOOR, PUT HIS FEET UP AND PATIENT WAS OK WITHIN 30 SECONDS.
Initial information was received from a consumer (patient's parent) on 08 July 2008. A 17 year old male patient with a history of hay fever and a family history of Hodgkin's Disease (patient's father): on 30 June 2008 received an intramuscular left arm injection of MENACTRA (lot number not provided). On 01 July 2008, the patient developed swollen lymph glands in the left clavicle area. The patient had a chest X ray completed and labs drawn (results not provided). The patient's swollen lymph gland continued to resolve. No additional information was reported.
My pre-existing hematoma/bruise was much worse when I undressed 12 hours after the vaccine.  There was increased swelling, darker color, the bleeding/bruising went down to my foot leaving pool sort of bruises at the sides of both sides of my heel.
This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 11 patients who, on unknown dates, developed HZ in the 7th year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010596). Additional information has been requested. Sender's Comments:  US-009507513-1703USA010321.
Extremely sore arm, chills with no fever, general body aches and tiredness that lasted 2 hours.
SORENESS, ITCHINESS & MUCH SWELLING. THE TREATMENT  I WENT TO THE DOCTOR ON  02/22/2019 AND WAS  PRESCRIBE AMOX-CLAV 500-125 MG TWICE A DAY AND  TRIAMCINOLONE ACETONIDE CREAM USP
Between 2 and 4 weeks after vaccination, I began to experience stomach and intestinal pain, then eventually after a couple more weeks, dizziness and sharp pains in my head, also experienced shortness of breath, weakness in my arms. I initially expressed these concerns about the stomach/intestinal pain to my doctor at the time, and he decided to have a CT scan done (lower pelvic region only) which proved negative for any issues.... since I was getting my yearly physical in September, we decided to wait until then to see if the head and  arm symptoms were still manifesting at that point. By that time, they had begun to abate. These symptoms began to ease over time (I would say that around 3-4 months after vaccination all of these symptoms had disappeared).
redness and swelling at the injection site; redness and swelling at the injection site; Pain in arm; unable to lift his arm above his head; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th March 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased. On 31st March 2020, the outcome of the injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: No Lot number or expiry details were known. The patient received Shingirx in the left deltoid last Wednesday (from the date of reporting). The reporter reported caused redness and swelling at the injection site.  It also caused pain in his arm and he was unable to lift his arm above his head.  He wanted to know if the second dose was the same as the first. The reporter declined to provide his medical doctor information.
Shoulder started to hurt. Tried OTC pain relief.  Finally went to doctor on 12/9/13 because pain was becoming severe and needed greater relief.  Was diagnosed as bursitis.  Treatment ineffective.  Saw another doctor on 2/20/14.  Recommended physical therapy.  Symptoms continue to worsen.  Difficulty dressing, showering, sleeping.
I woke up in the morning and felt like I was coming down with a mild cold. I had a slight headache, scratchy throat, achy chest, fatigue, congestion, and body ache. I took TYLENOL, and ADVIL to help relive those symptoms. I took an at home COVID-19 test that came back negative. I continued to have mild symptoms and re took a COVID-19 test on 7/30/2022 that came back positive. I went to an urgent care that same day and they prescribed me PAXLOVID. I am still experiencing the same symptoms.
While immunizing the patient, some of the M-M-R II vaccine leaked out of the syringe; This spontaneous case was reported by a pharmacist referring to an adult patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, frequency, route, lot# and expiration date not reported) for prophylaxis.  While immunizing the patient, some of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine leaked out of the syringe (incorrect dose administered).
About six hours after my shot I started having shortness of breath and heart palpitations. I went to the ER and they  gave me some fluids and testing and I was discharged the next day. I had a mild heart arrhythmia which was not present two days later when I went to the doctor. I had a little shortness of breath and experienced a few heart palpitations for a week after the vaccine. I have not had any more since then.
EXTREME HIP PAIN THAT INTERFERES WITH SLEEP AND DAILY LIFE. DOES NOT ABATE WITH TIME.
Elevated blood pressure 230/170 for over 24 hours. Dry mouth, Feeling of unease. Chilled, Insomnia. Loss of appetite. Joint pain, Headache for 6 days.
Manager and I went together to look at our AVP stock as patient is uninsured.  I thought I grabbed the adult AVP one and didn't realize that we had pediatric ones.  Patient was given first dose of Hep A by me on 10/20/2022.  Patient was notified as well as the provider of this incident.
Pneumonia vaccine administered on 10-OCT-2007 and Pneumovax administered on 15-OCT-2009; This spontaneous report has been received from an other healthcare professional via an immunization records from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2111USA004903), concerning a 71-year-old patient of unknown gender. The patient was not allergic to egg, neomycin, latex and gelatin. The patient's concomitant vaccine included unspecified quadrivalent influenza vaccine. The patient's concurrent conditions and medical history were not reported. On 10-OCT-2007, the patient was vaccinated with the first dose of unspecified pneumococcal polysaccharide vaccine (PPV) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiry date were not reported) for prophylaxis. On 15-OCT-2009, the patient received pneumococcal 23v polysaccharide vaccine (PNEUMOVAX) as a second dose (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis (Inappropriate schedule of product administration).  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2111USA004903:
pt recvd vax;2-3 hrs later, began inconsolable screaming & crying;t 101-103 x 2 days; crying persisted for 2 days;to MD 16dec94, t 99.3ax;no redness,swelling,using both arms w/ limitation;documented pertussis rxn per MD;
I was feeling tired and fatigued about 9:30, so I went to bed and I woke up about an hour later around 10:10:30. I had the chills and I was shaking real bad. I felt like I had a fever, and I got a compress and put it on my forehead. I tried to go back to bed and I could not sleep, I got up again about 12:30am and took two Aleve to try to get rid of my fever. While I was up getting the Aleve, I took my pulse and it was a steady 111 - 115, and it was just real high, and it stayed that way all night. With my history of A-fib, I thought that was going on with me, my temperature at that time was about 100.2. It was a low grade fever, I could not get to sleep. About 1:30 in the morning the shaking finally stopped, however my chills never stopped, and my heart was still racing, also I had really bad joint pain, every joint I have was aching. At 6:30 in the morning, I had my wife drive me to the ER. I was there for 3-31/2 hours, and it was determined that I did not have A-Fib and my pulse had went back down into the 90's, my chest x-ray turned out normal and they did not find anything wrong with my blood and my COVID-19 test was negative as well. I stayed fatigued for the next two days, I also had headaches throughout this whole ordeal.
Injection site pain, joint pain, mild headache, fatigue, fever (max 102.5) beginning late night of injection (3/26) approx. 11:45 pm and worsening throughout night and the next day. Symptoms began showing improvement in the evening of the day following injection (3/27) and more or less gone upon awakening on 3/28. Took 1000 mg Tylenol upon onset of symptoms and approx. every 6 hours.
This is a 24-year-old female who is 37 weeks and 4 days' pregnant, who received her second COVID vaccine (manufacture: Pfizer) at 1452 today.  She began experiencing throat itching and wheezing.  She was given albuterol and a shot of Benadryl, and she noticed some improvement in her throat itching.  She then received a dose of IV 125 mg Solu-Medrol, and then her hand started swelling.  Right side of her face became hot and red.  She began itching on her trunk, arms and legs.  She says that she has a history of "being allergic to everything and has learned not to panic in these situations."  She has a history of asthma since she was a child, and is currently on albuterol inhaler and a Qvar inhaler over the past 4 to
3 months after receiving the  2nd dose of the Moderna vaccine,  I began having the same issues that I had after the 2nd dose at the injection site.  That included a very sore upper arm from the top of my arm to a couple of inches above my elbow, for a weeks time. With the  2nd dose , I also had a rash and swelling.  This time it did not exhibit a rash or any swelling,  but my arm was painfully sore as it was after the 2nd dose.  I showed no other symptoms of any sort.
Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021; Patient received vaccine from vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J121A, 036B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022 at 10:48 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.   Date the vial  initially stored in the refrigerator  was 07-Feb-2022, date and time the vial first punctured was16-Feb-2022 at 10 am. The vial did not undergo any temperature excursions. Post puncture the vial was stored at room temperature and quarantined. Total amount of time the vial was exposed to room temperature range was 27 hours. Reporter does not know whether patient experienced events after vaccination.  No treatment details were reported.   This case was linked to MOD-2022-487921, MOD-2022-487957 (Patient Link).
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/04/2021 and 02/25/2021. They were brought to Emergency Department via ambulance after experiencing "garbled speech" which was concerning. Paramedics determined the individual was hypoxia (O2 at 69%), hypothermic, bradycardic, and hypotensive. They were unresponsive upon arrival to Emergency Department. They were admitted and tested positive for COVID-19 upon admission. They were found to be experiencing multiple complications and conditions in addition to the chronic conditions listed earlier in this form. They were found to have pneumonia, multiple decubiti, hypothermia (body temperature 36 C), an MRSA Urinary Tract Infection, and be septic. The individual's condition did not improve and they were transitioned to comfort cares only on 10/30/2021. They remained hospitalized until their death on 10/31/2021.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (strength, lot#, dosage and route unspecified) for prophylaxis. No adverse effect reported. No product quality complaint involved. No further information was provided. Additional information has been requested.
Left arm became warm, red and swollen. She continued to have swelling and pain 5 days after injection. Returned to clinic. Ultrasound of area was done and found an abscess. Fluid was aspirated from the area using guided ultrasound and sent to lab for testing. Patient was directly admitted that same day to the hospital for IV antibiotic treatment.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8733), in right arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish, mango; "Known allergies: Mango" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I continued to have symptoms and test positive for another 5 days; Positive, notes: I tested positive again; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received vaccine. Patient did not receive any other medication in 2 weeks.
Woke up feeling numbness and swelling in left side of face.  Went to emergency department and was told it was not a stroke but have been diagnosed as having Bell's Palsey.  This did develop from a reaction to the flu shot.
Fever of 101F, sore and aching body, tight jaw, headache, chills
No side effects for 7hrs, then injection sight slightly sore at 9p Thursday 4/22, 8a Friday 4/23 entire left arm ached and all joints ached.  By noon 4/23 increased aches in joints and tired.  By 4p 4/23, exhasted and took 2hr nap.  At 5p woke to severe aches all over body ( muscles & joints).  Fell asleep at 6pm 4/23, when awoke at 7a 4/24 exhaustion gone and only slight joint aches remained.  10a body seems To returning to normal as aches continue to subside and I have energy again to do things.
Bump size of an egg at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump size of an egg at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Neck pain. Concomitant products included HYDROCODONE for Neck pain, MELOXICAM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (Bump size of an egg at injection site). At the time of the report, VACCINATION SITE MASS (Bump size of an egg at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.