chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 25 May 2011. A 4-year-old child (gender not reported) had received on 23 May 2011 an intramuscular right deltoid injections of DAPTACEL and IPOL (lot numbers C3449AA, and D1086-1 respectively); and subcutaneous left deltoid injections of MMR and VARIVAX (manufacturer Merck, lot numbers 0743Z and 1474Z, respectively) and overnight, the patients arm became red, swollen, and the skin in the affected area was weeping. The patient required a doctors visit; however no relevant diagnostic tests and/or laboratory data were performed. It was also not reported whether the patient had required any treatments. The patient had no concurrent illnesses, pre-existing medical conditions or use of other medications at the time of the vaccinations; and had not received any other vaccinations with 4 week prior to 23 May 2011. It was noted the patient had not experienced any adverse events with past vaccinations. At the time of this report, the patient had not recovered. Follow-up information was received from a health care professional on 05 July 2011. The birth weight of this male patient was 6 pounds 12 ounces and he has 3 siblings. It was confirmed that the patient was vaccinated on 23 May 2011 at about 12:30 PM and on 24 May 2011 (previously reported as 23 May 2011) at about 3:00 PM the whole right arm became swollen, red and weeping. On 25 May 2011 at about 11:00 AM he was seen by a physician. He was instructed to continue taking BENADRYL and apply cool compresses. The event was considered serious by the physician. It took 5 days for him to fully recover. The outcome was reported as recovered on 28 June 2011. Documents held by sender: None.
Bladder infection and bacterial vaginosis likely unrelated to vaccine.   29 weeks pregnant at time of shot one, almost 30 and 5 days pregnant during visit involving infection.   Recovered from infection with antibiotics
Varicella like lesions, approximately 20 in number, scattered over face abdomen, and arm reported by mother over the phone to Dr.
Information has been received from a registered pharmacist concerning a 66 year old male patient with no drug reactions/allergies who on 12-AUG-2010 was vaccinated SC at the left deltoid with a dose of ZOSTAVAX (Merck) (lot number reported as "0512Z" which was invalid) in the pharmacy by the pharmacist. A "couple" of days later the patient called and reported a "rash" at the site of injection. The pharmacist stated that no treatment had yet been rendered and the patient again called today on 16-AUG-2010 to say that the rash was getting larger. It was not present on any other area of the body according to the pharmacist. The patient did not seek medical attention. At the time of report the patient's status was not recovered. Follow-up information has been received from the pharmacist concerning the patient who on 12-AUG-2010, at 02:15 pm, was vaccinated SC with a dose of ZOSTAVAX (Merck). Subsequently the patient developed a large rash at the injection site which subsided eventually on 19-AUG-2010. Additional information is not expected.
Swollen lymph nodes near collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes near collar bone) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes near collar bone). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes near collar bone) outcome was unknown. Not Provided          No concomitant Medications were reported.  No treatment details were provided.  Patient reported that lymph nodes were not painful.
Gradual progression of symptoms since receiving the third booster of the GARDASIL vaccine in January of 2008. Initial Labrynthitis diagnosed by student health center and costochrondritis in late March. Followed by extreme exhaustion and a diagnosis of depression. Fatigue increased. Tempromandibular Joint problems, severe headaches, and neck pain began in Spring. Hip and knee pain followed in April and has worsened to limping and sharp pain. Shoulder pain. Redness and stiffness of the hands followed in early May, followed by ankles. Also, in May, I started experiencing numbness intermittently in my hands. I am seeing a rheumatologist who is treating the symptoms and has made no diagnosis at this time. I am no longer able to work a full day and have spent most of my summer on the sofa. 8/18/08-records received for DOS 6/25/08-presented with C/O arthralgias and myalgias that began in March 2008 noted pain over right trochanteric bursa and pain when walking or standing for periods of time. Participating in spinning class. Stiff and achy in morning. Some numbness and tingling. Color changes in fingertips when exposed to cold. Heat rash on chest. Costochondritis. Pain in chest, headaches.   DOS 7/16/08-follow up visit. Improvement in symptoms after Medrol dospak. Assessment:potential inflammatory arthritis.
Inflammation, itchiness, edema approximately 2?x 4? around injection site, touch less skin temp of affected area 99.9 F, forehead temp at same time97.9F
muscle aches; Violent shaking all over; dry heaves; extreme chills; vomiting; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 6:00 PM, the patient experienced TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache). On an unknown date, the patient experienced MYALGIA (muscle aches). At the time of the report, TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she called 911 when events happened, but she did not go to the hospital.   Concomitant medications were not provided.  Treatment information was not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 6:00 PM, the patient experienced TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache). On an unknown date, the patient experienced MYALGIA (muscle aches). At the time of the report, TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she called 911 when events happened, but she did not go to the hospital.   Concomitant medications were not provided.  Treatment information was not reported.
Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.
No adverse event; Bivalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered after the BUD to patient).    No concomitant medications were reported.  It was reported that, the patient received bivalent doses after the beyond use-by date.  No treatment medications were reported.
Injection @ 9am.  Fever (100°),  chills/ shivering,  fatigue,  sore muscles (lower back,  hips,  thighs) began around 8:30 - 9pm.  Woke at 12am & HR was 160bpm, still had fever. Woke at 6am & took temp several times until 8am..Had fever/temperature between 102°-103.8°. Felt fatigued throughout the day, HR ran between 125-135 & temp ran between 100° -102°. Temp broke sometime in the am hours of Jan 8. Woke up at 6am and temperature was 98.0 & HR was 85bpm. My left shoulder muscle was swollen & itchy through Jan 15th. The soreness in my left arm disappeared on Jan 13th. I took Tylenol for temperature and drank plenty of fluids.  Was very concerned about increased heart rate.
Cough started 10 minutes post shot.  Felt like congestion in lungs.  Persisted the remainder of the evening/night.  Gone by next day. Fatigue  day after shot. Swollen, sore lymph node in armpit of arm that received shot.  Symptoms still ongoing.
1540 Pt complaint of feeling nauseous, states feels this was when anxious.  Pt at POD with girlfriend. Squad was called for girlfriend earlier after girlfriend fell to ground.  States anxious watching all that happen.  Denies any other symptoms.  Drank Capri sun.  1551  BP 118/60, RR 18, O2Sat 99%, HR 87.  States feeling much better.  States ready to go home.  Advised pt to seek medical care if experiencing symptoms.  Pt verbalized understanding.  1553 Pt left with girlfriend at his side.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with anxiety, depression, self mutilation and ampicillin allergy who on 22-MAR-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL. On 30-JUL-2008 the patient was vaccinated IM with the second 0.5 mL dose of GARDASIL and on 03-JUL-2009 was vaccinated IM with the third 0.5 mL dose of GARDASIL (LOT# 661764/0650X). Concomitant therapy included albuterol and QVAR. Subsequently, the patient experienced vaginal bleeding and found out that she was pregnant when she went to see her Obstetrician/Gynecologist. Ultrasound was done. The date of last menstrual period was on 25-JUL-2009 and the estimated delivery date will be on 01-MAY-2010. Additional information has been requested.
headache, myalgia, nausea, vomiting, and facial swelling x3 days
Information has been received from a nurse practitioner as part of the pregnancy registry for Gardasil concerning a 17 year old female with no history of drug reactions/allergy who on 16-FEB-2007 was vaccinated with a first dose of Gardasil (lot # 656049/0187U) 0.5 ml IM. On 06-JUN-2007, was vaccinated with a second dose of Gardasil (lot # 657736/0389U). There was no concomitant medication. Medical attention was sought. It was reported that the patient did not know she was pregnant until a baby was delivered on the patient's bathroom floor on 21-JUN-2007 at an approximated gestation of 30 weeks. Estimated date of delivery September 2007. The baby died eight days later on 29-JUN-2007 of schizencephaly. The patient claimed to be unaware of her pregnancy because she had her menstrual periods throughout her pregnancy and did not gain weight. The patient had no prenatal care. No other information was available at the time of reporting. Additional information has been requested.
Info has been received from a physician concerning an 18 month old pt who "12 months ago", in 4/04, was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt "developed zoster on the trunk, just one dermatome". Unspecified medical attention was sought. It was reported that the pt's adverse experience resolved on it's own, and at the time of the report, the pt was recovered. There was no product quality complaint involved. Additional info has been requested.
Felt for about a week after the shot had gait problems, and felt very unsteady walking. Had to have a friend hold him up couple times. Had trouble staying balanced when moving.
pt recv vax; 6 hrs later, devel swelling & rash; tx w/ meds & sx relieved;
NA  CAD, Chronic Abd pain with Opioid treatment - Chronic Pancreatitis
body broke out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 17:00 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Apr2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "No adverse effect"; Bnt162b2 (Dose 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: URTICARIA (non-serious) with onset 15Dec2021 06:00, outcome "recovering", described as "body broke out in hives". Therapeutic measures were not taken as a result of urticaria.  Additional Information: It was stated that, when she woke it was fine but after an hour body broke out in hives. They completely covered legs from the knee up, and they were on arms as well. The patient was not tested to Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. fainted after shots, pt brought to back laid down, cool compress applied to forhead, ; rice & crackers given.
I have had multiple adverse effects since the first hour I received  this vaccine . I started within the first hour with an extreme headache and foggy cognition my entire arm began to turn red down to my hands and it felt as if I had a tourniquet placed on the injection site and my lower arm felt tingly and the blood supply was lacking  . I felt lethargic and only what I could describe as a dream like state .  Within 3 hrs I had a low grade fever , body aches and cold sweats this continued for 4 days as well as the redness to my arm . After the first day the following morning I had started  menstrating for  the second time that month as I had just finished my regular cycle a week prior to the  vaccine . I have been regular on my cycle for the last 16 years and this was the first time I have ever become irregular. The bleeding was extremely heavy with large blood clots and the bleeding was painful . It was the first menstration I have ever had . This also continued for 6 days. At day 4 the cold sweats became less frequent and the fever had subsided and the redness in my arm had faded but the feeling of nausea and headaches started and have not stopped . I am having to take medication for nausea daily and am more lethargic than I have ever been .  I have not yet felt myself again and continue with this I'll Feeling .
didn't reconstitute the Hib with the (DTaP/IPV). The cohort also didn't reconstitute the Hib with the 0.4 percent NaCl and gave it / no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (with unknown demographic) who received dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) (lot number and Expiry date unknown) via unknown route in unknown administration site.  The patients' medical history and concomitant medications were not reported.   It was a case of actual medication error due to inappropriate reconstitution technique. (it was reported that The cohort didnt reconstitute the Hib with the (DTaP/IPV). The cohort also didnt reconstitute the Hib with the 0.4 percent NaCl and gave it)  At the time of reporting, no adverse reaction was reported.  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 Directive and Module VI of the 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.  Information on the batch number was requested.  Documents held by sender: none.
Mom called on 10/27/2021 to report that on 10/20/2021 her daughter had developed a low-grade fever, a "golf ball" size knot with a red circle around the area where the injection was given, and a full-body rash.  Mom took the child to the doctor on 10/22/2021 because of the rash and a sore throat and was diagnosed with strep and put on amoxicillin.  Mom states that she has been on amoxicillin before and has had no problems with taking it, also no problems with the first dose of MMR/Varicella.  Mom did state that there is an extensive family history of severe to anaphylactic reactions to the MMR vaccine.    Pt told mom that on 10/25/2021 that her tongue hurt, mom noticed that her taste buds were swollen.  Mom thought is was just because the pt had just eaten ramen noodles and maybe it was too hot.  The pt complained of pain on her tongue again the morning of 10/26/2021 mom thought the taste buds still looked a little swollen and had a white color to them.  She had no other symptoms so mom sent her to school.  Later that day the school called mom to come pick her up because she was not feeling well.  The pt told mom that her tongue hurt really bad, mom noticed that the spots on her tongue were now yellowish/white lesions x3 and painful.  Mom called the doctor to get an appointment and then called us to update us on what had happened.   Mom stated that she would call us back after seeing the doctor to let us know what the diagnosis is from the doctor.
Extreme dizziness,  brain fog, fatigue,  general unwell feeling, random heart palpitations all on going