chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 11:30 the evening of the vaccine pain radiated down the entire arm of vaccine site and to the chest and neck. The entire shoulder blade. The pain improved and has settled into the shoulder joint. The arm pit and shoulder joint and neck lymph node remain tender and painful on day 4 post vaccination. Ibuprofen and ice packs have been used for treatment.
Bruising on his arm to the elbow a few days after the booster shot was administered.
102 degree fever. Headache. Right lymph node swelling, tenderness, arm tingling. Nausea. Intestinal "issues" was awakened during the night with these symptoms 2-2-15 Pt. had received RABAVERT.
This was administering the Meningitis and HPV vaccine to the patient when he suddenly became unresponsive and was convulsing. The patient was unresponsive for approximately 5-10 seconds and had 2-3 noticeable convulsions prior to regaining consciousness and sitting up. Also present in the shot room was the patient?s mother and younger brother. The patient was seated in the clinic bench, when the vaccine administration occurred. This PHN administered the meningitis vaccine in the patient?s left deltoid without concerns. This PHN then administered the HPV vaccine in the patient?s right deltoid, and within seconds the patient slumped into the chair and his body convulsed 2-3 times. This PHN braced the patient on the bench and attempted to lean him over slightly, but the patient?s brother was also seated on the bench still. After 5-10 seconds the patient regained consciousness. This PHN continued to assess the patient and reassure the mother that this is a known reaction to vaccination, and the HPV vaccine. This PHN also inquired about hydration status, and expressed concerns about the patient being slightly dehydrated as well. This PHN explained that the convulsions didn?t appear to be seizure related, but that the patient?s primary provider should be made aware of the incident. This PHN check the patient?s blood pressure and it was 126/68, pulse 55, and SPO2 99%. This PHN then asked for Dr. to assess the patient. Dr. assessed the patient and stated that his pulse was slightly low but otherwise normal findings. Dr. reassured the mother that her son was likely slightly dehydrated and additionally had a vasovagal reaction to the vaccination. Dr, also explained that the convulsions were the body?s response to the shifting of blood from the brain and decreased heart rate, and likely not seizure related due to lack of post ictal state. The family remained in the clinic for approximately 30 minutes after the appointment time for assessment and reassurance. This PHN documented the vaccination reaction.
hepatitis B nonresponder; Literature Report:  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 41 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 42 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 7. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Pt received the 1st dose for Moderna-Covid-19  vaccine on 12/23/2020. When information for database was documented, it was found, she had the 1st dose for Pfizer Covid-19 vaccine on 12/17/20. She was notified and spoke with one of our physician, She did not report any sides effects. Pfizer and Moderna pharmaceutical's were reported.
Red face, hives. Advised Benadryl 3/4 tsp on 5/21/03 - continue 9 times, every 6 hours until no hives at 24 hours. All hives gone by next morning.
The mother reports to HD this morning with a complaint of left deltoid redness, swelling, itching with fever to site. Mother phoned ER on 8/22/01 PM and was instructed to use ice packs; child assessed on 8/23/01 at 08:18 AM here at DCHD and instructed to use ice packs and contact MD tomorrow if none better. Appears to be a local reaction; no signs or symptoms of septicemia at this time.
Was sweaty, unresponsive, and breathing shallow a few mins after administration. BP 97/68. Within a few mins, patient became responsive and BP 146/81. Patient chose not to go with EMS and walked out of store after they were feeling better. Today (3 days later) received report from medical examiner that patient passed away.
Soreness at injection site - very red - extreme itching - painful shoulder to wrist at location and spread slightly down arm.
Narrative:  Covid +, Moderna #2, SOB, CHF, 92 years old, home with hospice
Patient received passive antibody therapy on 02/14/21 while hospitalized as part of mild COVID-19 treatment in the last 90 days.  Patient administered the first COVID-19 Moderna vaccine on 03/02/21 and again on 03/30/21.
sore throat; cough; runny and stuffy nose; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), COUGH (cough), RHINORRHOEA (runny and stuffy nose) and FATIGUE (fatigue) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), COUGH (cough), RHINORRHOEA (runny and stuffy nose) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat), COUGH (cough), RHINORRHOEA (runny and stuffy nose) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. The patient would not be taking the second dose.
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 24-OCT-2012 19:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: He received the shingrix shot on 4/21/23. No reaction but on 4/27/23 his arm became swollen. From the top shoulder deltoid area extending all the way down to elbow. It is all red itchy swollen and warm to the touch. Pt had seen his primary care in the morning and his primary care told him not to get the second dose.
Symptoms:  chills, fever 99.7,  Treatment: Dayquil Outcome: Symptoms continued following OTC meds
Incredibly itchy rash covering my back, plus chest, stomach, backs of knees, and crooks of elbows.
Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Pt recvd flu vax in DEC92 pt exp flu-like sx, dizziness & imbalance; pt was admitted to the hosp in an encephalopathic state;
This case was reported by a healthcare professional and described the occurrence of headache in a 46-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline).  Concurrent medications included LEVOXYL and Fluoxetine hydrochloride.  On 27 May 2010 at 10:35 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm).  On 27 May 2010 in the afternoon, less than one day after vaccination with TWINRIX, the subject experienced headache and nausea.  The subject almost attended the Emergency Room due to the nausea being so bad later that afternoon.  The healthcare professional considered the events were disabling.  On 28 May 2010, the events were resolved.  The healthcare professional considered the events were probably related to vaccination with TWINRIX.
10x20 cm area of swelling & erythema & soreness in region of inject (reported 19JAN95 by parent);
Painful, redness rash around injection site start happening day after injection. It has lasted for more than 1 week. After one week the pain went away, but still redness. The redness area has gone down since the beginning stages. No other symptoms.
Pt received Pfizer COVID bivalent booster for ages 5-11 instead of intended 12+.
Pain at injection site, swelling and tenderness at deltoid mm origin, limited range of motion- left shoulder.
Varicella like eruption at site of injection and over torso/back 50-80 lesions; Abdomen 70 to 100 lesions.
feeling ill; Headache; sinus pressure; sore throat; chills; sweats; cough; extreme tirednes; arm was really sore; This is a spontaneous report received from a contactable consumer (reporting on herself).   A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 229Jan2021 12:00, as unknown, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose on Friday 29Jan2021. Friday, Saturday and Sunday her arm was really sore. Tuesday (on 02Feb2021) she began feeling ill. Headache, sinus pressure, sore throat, chills, sweats, cough,  no fever and extreme tiredness. These symptoms lasted through Thursday. Adverse event result in go to Emergency room/department or urgent care. No treatment received for the adverse event. Since the vaccination, the patient has tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Feb2021.  The outcome of the events was recovering.  Information on the lot/batch number has been requested.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt developed 2 swollen lymph nodes in right inguinal area, 1 cm and 1.5 cm in size.
Extreme and unprecidented manifestation of rosacea; extreme sensitivity on face to sun and heat including once, hives (photo available). Delayed medical attention until physical in late July. Dermatologist prescribed sun avoidance,  and Metronidazole Topical Gel, and Minocycline; adhered to both over subsequent weeks and stopped the medications after six weeks. They symptoms waned and did not reoccur after cessation of medication.
Information has been received from a health professional concerning a 17 year old female who on 13-FEB-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) 0.5 ml in her left deltoid (lot# 655327/1287U0. Concomitant therapy included CELEXA and minocycline. On approximately 16-FEB-2008 the patient experienced dizziness and was taken by ambulance to the emergency room. It was unspecified if the patient was admitted to the hospital or just treated and released by the emergency room. It was determined in the emergency room that the patient had a "probable allergic reaction" to GARDASIL vaccine (yeast), which also included a rash and hives. The patient was treated with BENADRYL. Additional information has been requested.
Gout; This is a spontaneous report from a contactable Other HCP who was dentist (reporting himself).  A 68 year old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246, expiration date: unknown), via intramuscularly in right arm on 14Jan2021 at 14:00 as a single dose for COVID-19 immunization. The patient had no known medical history and concomitant medications. The patient did not receive any other vaccines administered on same date of the COVID vaccine. The patient did not receive any vaccine with 4 weeks of Pfizer vaccine. The patient had no AE's prior COVID vaccination. The patient did not undergo any lab test. On 15Jan2021, the day after vaccination, the patient had gout which was never had in his life. The patient did not go to any emergency room or physician office. The patient took unspecified medication for the event and it went away in about two days. The patient stated that the event was not too serious and it just hurt when walked. The patient thought he never had gout before and was very coincidental. The patient was in good health. The patient related the event. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9265, expiration date: unknown), via intramuscularly in right arm on 04Feb2021 at 13:00 as a single dose for COVID-19 immunization. The patient was far did not have gout after the second dose and hoping he would not get it. The outcome of the event gout was resolved in Jan2021.  Follow-up attempts are completed. No further information is expected.
Headache; Chills; Sore arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CCDPH/VW) via an unspecified route of administration on an unknown date (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced headache, chills and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, chills and sore arm. The clinical outcome of the events headache, chills and sore arm were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
ROTATEQ administered first. PEDIARIX then given IM in left thigh. Infant cried, held breath, got red in face, mother noted lips got blue. Infant was staring then went limp and began breathing again. This occurred immediately after administration. Infant was back at baseline within one minute.
Pt received hep B, cried; nursed; approximately 20 min later, while being strapped into infant car seat, began to cry. Stopped suddenly, was noted to be pale, labored respiration. No L.O.C. No specific intervention. Resolved post approximately 2-3 minutes. Admitted to eval. D/C dx: ? choking episode ? breath holding.
This is a 83-year-old man with chronic idiopathic pulmonary fibrosis who developed COVID 19 and acute hypoxemic respiratory failure. The patient has previously declined any intervention for his chronic lung disease. Previously the patient reported no significant difficulty breathing only mild dyspnea with exertion. He reported that he was fairly functional and had no impediment to performing his ADLs or IADLs. The patient was hospitalized in late January after a fall at home. He was also found incidentally to have COVID-19. Patient was monitored over 10 days for failure to thrive and malnutrition. The patient was to be discharged to a SNF but he suffered an acute hypoxic episode and required 10L O2 acutely. The patient has baseline IPF without evidence of chronic hypoxemia. However, likely due to his COVID-19, he became acutely hypoxemic. CTA was negative for PE. Patient required transfer to the ICU for ongoing progressive hypoxemia. He was started on vapotherm. He was started on baricitinib in addition to his dexamethasone.  Patient requesting comfort measures
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, injection site, lot# and expiration date were not provided). On an unknown dates, the patient had tenderness at the injection site for a few days. The patient did not receive any treatment for tenderness at the injection site. The pharmacist also stated that he 'normally hears this complaint after PREVENAR 13 injections and not generally after PNEUMOVAX 23 injections'. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
This spontaneous report as received from a consumer refers to an approximately 46 year old female patient reporting on herself. In January 2007, a Papanicolaou (PAP) smear and hormones tests were done which resulted normal. In March 2008, a colposcopy and blood tests were done (results were not reported). In March 2008, the patient was vaccinated with GARDASIL dose 1 (route and lot number were not reported) on doctor's recommendation. In late May 2008, the patient was vaccinated with GARDASIL dose 2 (route and lot number were not reported). On an unknown date in 2008, after receiving GARDASIL, the patient's bilirubin became so elevated, that after a certain course of events she was admitted (from approximately May 2008 to July 2008) to the liver transplant ward in a hospital for 2 months. The patient had bilirubin levels measured from November 2007 until August 2012 (results unspecified). In May 2008, the patient signed a stent uninformed consent. On 02-JUN-2008, the patient had a stent placement. On 18-JUL-2008, the patient experienced liver surgery stent removal. The patient reported that her amended preadmission consent was misplaced. On an unknown date, the patient stated that a physician tried to get her to sign a care plan stating that she had ongoing drug, cigarette and alcohol abuse, as well as falsely claiming she had significant psychiatric problems (the patient refused: medico legal). On an unknown date, an in-vitro fertility (IVF) specialist, made light of the patient's fertility issue and egg saving. The patient did not save eggs prior to surgery with risk if death at age 46. On an unknown date in 2013, reported as 2013/2014, the patient experienced accumulative right side muscle and nerve damage post-surgery, spine twist and subsequent damage to right leg. The patient stated that it was a wonderful blessing that she did not die and that she would like to contribute to clinical trials to help perfect GARDASIL, as she had carefully put together reports, blood tests internationally over 20 years from eminent specialists. The outcome of liver surgery stent placement, liver surgery stent removal, damage to right leg, spine twist, accumulative right side muscle and nerve damage post-surgery, fertility issue and bilirubin became so elevated was unknown. Causality was not reported. Upon internal review, stent surgery and liver surgery stent removal were considered as medically significant events. Additional information has been requested.
June 11, 2023 midnight: Headache and not feeling well.  Requested a cool washcloth for her head. Had a small liquid emesis. Prn emetrol offered but declined. Requested to go to restroom and had a large bowel movement. She stated she felt better.   Assisted back to bed.  She was monitored often. 2 tylenol 325mg given for temp. Around 3am, she was found unresponsive with secretions, rattles in lungs.  Mottling started from hip to feet.  Family called.  She was monitored often. Family arrived to be with her.  She passed around 5am.
Mom noticed next night after removing bandaid,had a red raised area with bumps about the size of quarter. Area was painful to touch. Area has improved but still has raised bumps.
PATIENT CAME BACK TO THE PHARMACY AROUND 1130AM THE DAY AFTER THE VACCINATION, SHE SAID SHE WOKE UP WITH A RASH ALL OVER HER ARMS AND LEGS.  TOLD HER TO TAKE SOME BENADRYL AND IF THE SYMPTOMS GOT WORSE OR DID NOT IMPROVE THEN GO SEE A DR.
pt recv vax 1OCT98 & returns to clinic 2OCT98 w/raised reddened area @ inj site;
I had a severe lymph node swelling in chest, neck, breast, down to my elbow. I couldn't put my right arm down. I called my doctor to let him know. I had horrific back pain and still going to physical therapy since I had vaccine. I also had vaginal bleeding.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) in a patient of an unknown age and gender 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 MYALGIA (Soreness). At the time of the report, MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.