chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This 33 year old female received her first AVA (FAV067) on 1/14/2003 and primary SPV (lot # 4020771) on 2/03/2003. Records document complaints of headache, muscle aches, feeling lousy, with swollen axillary lymph nodes and a 7x7 mm vesicle with slight erythema that scabbed ("major take" 2/16/2003) after her SPV. She also advised having a dental cavity filled <30 days prior to vaccinations.On 3/22/2003 (day 49) she reported to medical for 3 days complaint of left>right ear pain with yellowish drainage from her left ear, a sore throat, her "whole body hurts", photosensitivity, watery eyes, tired, headache and sense of being off balance. She had some nausea and vomiting 2 days ago. She was diagnosed with pre-otitis media and given MOTRIN and CEPROCOL throat lozenger. On 4/6/2003 (day 63) she complained of fever and flu like symptoms x 3 days being cold, had pressure in back and around eyes, back of neck unrelieved with EXCEDRIN or MOTRIN. She was diagnosed with acute sinusitis and dehydration and treated with SEPTRA DS, AFRIN nasal spray, SUDAPHED and TYLENOL with IVF's. Symptoms resolved and on 4/30/2003 she was evaluated for stress (death of 2 friends) reporting poor appetite x 1 month. On 5/7/2003 she presented to medical with diarrhea and vomiting x 24 hours, fever, hot/cold chills, night sweats, with positive tilt test and diagnosed with gastroenteritis (no lab/diagnostics studies). On5/10/2003 she was re-evaluated for resolving viral gastroenteritis (VGE). On 5/25/2003 she complained of heat exhaustion while on pier watch with temperature of 104.1 (no longer sweating and outside air temp 100+ degrees), skin flushed hot and dry, fatigue, a non-productive cough x 1 week, nasal congestion, and a sore throat. She also complained of increasing dry non-productive cough with chest comfort with difficulty breathing in secondary to coughing. She described this chest discomfort "as if someone was sitting on my chest" with radiating abdominal and flank pain. CXR's showed hilar lymphadenopathy and enlarged mediastinum with diagnoses of mediastinal lymphadenopathy, pyelonephritis, mild anemia and elevated LFT's. She was medevac's on 5/30/2003. After several difficult biopsies her second VATS procedure (June 2003) confirmed the diagnosis of malignant lymphoma, diffuse large B-cell type with extensive necrosis and multifocal severe lymphoid infiltration or non-Hodgkin's lymphoma. On 6/28/2003 she received AVA #2 (FAV067). On 7/1/2003 she was admitted Stage II-A diffuse large cell lymphoma for chemotherapy via EPOCH-R protocol. In October 2003 and May 2004 repetitive PET scans showed remission and marked reduction of mediastinum tumor mass. Meanwhile, AVA #3 (FAV067) was given on 2/10/2004 with no reported adverse event or reflare of symptoms reported. In April 2005 she was found for work; however in October 2005 a PET/CT scan revealed new activity with biopsies showing Hodgkin's lymphoma (HL). She underwent further chemotherapy in 2005 requiring PROCRIT due to chemo induced anemia, a stem cell transplant in 2006 and was deemed to be in full remission by 2007 where she remains today (2013).
Pt was giving this dosage, however this strength is for 4-6 years of age normal pediatric nurse is out on Quarentine due to COVID-19
Chills, followed by severe arthritic type pain in joints and muscles, sleep disruption, shallow breathing.  Second day loss of appetite, loss of energy and pain, second night mostly aches and pains, but vivid dreaming.  No arm pain.  Some depression.
1st dose- I did not have a reaction other than sore injection site 2-nd dose- I had fever/chills, vomiting/diarhea, strong headache, sluggish, muscle aches, joint aches, confussion or foggy thoughts
First shot had fever and chills for a few hours.  2nd shot I had chills, joint pain, migraine, and vomiting.
A quick onset of a burning itch under the breast area and extending to my back with redness.  Lasted for approximately one half hour and then subsided.  I did put on anti-itch crème but it did not help.
On 6/4, started having muscle ache when she woke up. On 6/5, states has bell's palsy (side of face is pulled down, cannot squint right side)
Has changed menstruation cycle permanently. Had normal menstruation cycles of 29-31 days prior to vaccine. After fully vaccinated has made cycles 45+ days or currently not menstruating at all. No life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 27Apr2021 at 13:15 as dose 2, single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 05Apr2021 at 12:00, outcome "not recovered", described as "Has changed menstruation cycle permanently. Had normal menstruation cycles of 29-31 days prior to vaccine. After fully vaccinated has made cycles 45+ days or currently not menstruating at all. No life". The event "has changed menstruation cycle permanently. had normal menstruation cycles of 29-31 days prior to vaccine. after fully vaccinated has made cycles 45+ days or currently not menstruating at all. no life" required physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Has changed menstruation cycle permanently. Had normal menstruation cycles of 29-31 days prior to vaccine. After fully vaccinated has made cycles 45+ days or currently not menstruating at all. No life style changes have been made. No treatment received for AE. No covid symptoms prior to vaccination. No known allergies and no medical history was reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vertigo since receiving both doses of the vaccine; This is a spontaneous report from a contactable consumer (reporter's friend). A 76-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date, as dose 1 and dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced vertigo since receiving both doses of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Information has been received from a physician referring to a 7 year old patient of unknown gender. The patients' pertinent medical histories and concomitant therapies were not reported. On 26-AUG-2016, the patients received a dose of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017)(dose and route of administration were not provided). No adverse symptoms were reported. No product quality (PQC) was involved. This is one of 5 reports received from the same reporter. Additional information has been requested.
Narrative:  Patient was immunized in timely manner 3-13-21 and 4-3-21 with pfizer mRNA vaccine. On 4-16, patient stated he started having facial weakness, mouth numbess/paralysis. Patient sought emergent care at local facility. He was sent to another hospital for possible stroke. That was ruled out and he was diagnosed with Bell's Palsy. He was treated with a valacyclovir and prednisone with little immediate improvement.
w/in 24 hrs of inject, pt had pain in arm beginning @ the site of inject, moving to lower arm & hand; pain w/some numbness have persisted since that time; pain worse when trying to close fingers in fist & w/greater activity;
Patient received immunization at approximately 0753 and was seated in post-immunization observation  area. 0821 patient observed to have mild cough and developed a hoarse voice. She was asked if she was having difficulty breathing and speaking and responded in the affirmative. 0823 Benadryl 50 Mg was administered in right Deltoid, followed immediately by epinephrine by Epipen by Pharmacist. Oxygen administered. 0825 911 system initiated. Patient having increasing difficulty speaking and cough, hoarse voice. 0827 Epinephrine administered to left deltoid by Pharmicist. Patient indicated that breathing was difficult, but less labored. 0831 paramedics  arrived and administered3rd dose of epinephrine. Oxygen saturation was 100% with 2 liter. BP/ 19/8
After receiving the Covid-19 untested vaccine in May2021 I developed Rheumatoid Arthritis within a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "After receiving the Covid-19 untested vaccine in May2021 I developed Rheumatoid Arthritis within a week". Clinical courses is as follows: After receiving the Covid-19 untested vaccine in May2021 the patient developed Rheumatoid Arthritis within a week. Is there any compensation without going to Court for this situation. The patient would have appreciated the truth prior to taking the vaccine. The patient know there were a number of folks paid to keep quiet about the Vaccine and we were Guinee Pigs for this issue for Pfizer. The patient never had an issue until the Vaccine was touted as safe. Trust me, It cuts your life by at least 5 years w/ much pain. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I've been using a continuous glucose monitor for years, and my blood sugars are in good control.  Starting the day of the vaccination and continuing for about two more days, my blood sugars were abnormally high (above 200 mg/dl) much of the time, and it was difficult to keep them in the normal range.  I've not experienced this reaction to any vaccination in the past.
patient came in for second shingrix patient accidentally got the pfizer covid vaccine when he already got the 2 monderna vaccines in february
no immune response; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (no immune response) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MYCOPHENOLATE MOFETIL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (no immune response). At the time of the report, IMMUNE SYSTEM DISORDER (no immune response) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment information was  provided.
Pt given MENACTRA. Then given HPV in other arm. Immediately after injection pt crossed arms around herself, fell backward and jerking arms and legs. Eyes open. Lasted 3-4 sec. No recollection of episode. Shaking and disoriented after for few seconds. No history of syncope with vaccines or seizures. Monitored 20 min and ok. No erythema around injection.
Information has been received from an RN concerning a 38 year old female pt who on 4/24/00 was vaccinated with a 1st dose of Hep-B, IM in the left deltoid. The same day, post vax, the pt experienced a sore arm, itching, a rash and felt "extremely fatigued". The pt saw a dermatologist. Follow-up information from an RN indicated that the dermatologist dx'd the pt with eczema. On 5/5/00, the pt recovered.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was recived from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 18-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excurson total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until aftre the first fact due to employee errror of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occured in the point of storage in clinical practice.  This is one of several reports recived from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
6/14 Dr ofc - Rash all over papular no fever. 6/15 - 0430 ED hospital. 6/14 - 100 degrees R - febrile seizure. Dosed with TYLENOL and MOTRIN.
Red, whelps, itching on affected arm (L) and now on legs and trunk using hydrocortisone cream 1% and BENADRYL 25mg Q 6 hrs.
12a fever, chills, achy for 24hrs.  Tylenol extra strength q6hrs
mom called 9SEP93 3PM; just noticed flat red rash on pt abdo, buttocks, legs; no fever or other complaints; mom did not notice this rash on pt this AM;
WARM SENSATION/FLUSHING ROLLED THROUGHT BODY FROM HEAD TO TOE. FELT DISORIENTED. ABLE TO WALK. DENIES DIZZINESS. THEN FELT TINGLING TO FINGERS ON LEFT SIDE. SYMPTOMS RESOLVED AFTER 5 MINUTES.
pt is not vaccinated 08/20/23 59.4 kg (131 lb)     Physical Exam: General: Alert, well appearing and in no distress and speaking in full sentences. Appears tired but non toxic appearing.  Heart: regular rate and rhythm Lungs: clear to auscultation, no wheezes, rales or rhonchi, symmetric air entry Abdomen: soft, nontender, gravid Vertex confirmed by bedside ultrasound Transabdominal ultrasound: Presentation: cephalic, Fluid: normal appearing Transvaginal ultrasound: cervical length 4.05 cm   Cervical Exam:    deferred   The exam was chaperoned by RN.     Uterine Activity: Mode: TOCO DYNAMOMETER;MONITOR APPLIED  Uterine irritability noted  Fetal Assessment: Baseline Fetal Heart Rate (Baby A): 160     Membranes and Fluid:    intact     Urine dipstick shows positive for trace protein, moderate ketones.     Patient Assessment: Reassuring fetal status and Uterine contractions, rule-out labor  Active Hospital Problems   Diagnosis   ? (Principal) PRETERM UTERINE CONTRACTIONS       Plan: Observe, Reevaluate in about 2 hours COVID test sent IV Fluids (1 Liter) Pending Study Results at Discharge: None   Issues to be Addressed in Follow-up: COVID -19   Addendum: Pt received IV fluid bolus. UC's resolved. Informed pt of +COVID test. Discussed r/b of paxlovid-declines paxlovid. Reaction (sz) after tylenol use in childhood so listed as an allergy and declines. D/C home and sent message to clinic staff to arrange RN phone calls to check in given unvaccinated.                Note Details  Author (M.D.) File Time 8/21/2023  1:51 AM Author Type Physician Status Addendum Last Editor (M.D.) Specialty Obstetrics & Gynecology Hospital Acct # Admit Date 8/20/2023  Admission (Discharged) on 8/20/2023  Admission (Discharged) on 8/20/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  08/21   Discharged 0203
Patient state that one week after the shot she stated having a mensuration discharge. Went to the Dr. pap smear was given on June 3rd  and all test came back normal.. She is one year into mesopause. June 5th. Headache, fever over 100.2 and body was very week. Went too urgent care on June 7th. They took more test and samples. Negative for COVID. all test was normal except white blood cells were high. June 8th went to PCP more test were taken. Inflammation enzymes marker was high. June 10th fever went away. June 13th developed water stool. The stool and the discharge are still ongoing. June 18th went to urgent care more test. White blood cells were high again but still no cause of infection. June 24 went back to the Dr. ultrasound was performed. Came back normal.  Patient believes that something from the shot has lounged into her Reproductive and intestine to cause these problems.
low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) 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 31-Jul-2021, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs provided.  No treatment drugs provided.
Cough; Muscle or body aches; Headache; Congestion or running nose.
Started to show symptoms of chicken pox-spots September 13, 2006.  No hospitalization.  Treatments for itchiness and other symptoms.
Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006022: US-009507513-2109USA006023:
Mom called stated child woke up at 3:15 AM vomiting one time. Child alert and talkative. Child vomited again at 8:30 AM. Mom stated does not act like he feels bad. No complaints of pain in arms from immunizations and shed call MD if no better.
Pain/redness at site. Myalgias and arthralgias whole body. Chills and sweats.
While prepping vaccines for patient, Men A was correctly prepped and given. TDAP was given incorrectly at time of vaccination. Patients arm was very sore for a few days. But since then has gotten better.
At immunization site, area 4" wide by 4 1/2" long reddened, hard and warm to touch. Mom states redness started yesterday, increase in area post bath last night and today. Pt to be seen by PCP today at PCP office. Staph infection per MD on PCP exam on 8/11/02.
Patient came in for the first dose of the COVID19 Moderna vaccine and reported that he hasn't had a vaccine in 12 years. I reassured him that it was a good time to get this vaccine due to the pandemic and tried to keep in good spirits; he appeared a little nervous. After the vaccine, he stood up and walked over to our waiting area. He walked regularly and sat down. Patient was sitting for a few minutes before the pharmacy technician saw him "slide" down his chair and onto the floor. Patient was unconscious but easily arousable. Regained consciousness after a few seconds. Patient was still breathing and had a pulse. After patient regained consciousness, he said he has a history of passing out after getting his blood drawn/getting a vaccine.
Pain at the injection site started in the evening of 1/12/2021.  It went away after 2-3 days.  Redness and itchiness started on 1/14/2021.  Applied hydrocortisone cream for 3 days then resolved.  However, the redness and itchiness returned  on 1/20/2021.  Possibly caused by irritation form blood pressure monitor cuff or slept on the left side of body in the previous night.
pt recvd vax;24-48 hrs later exp herpes zoster for 3 wks; pt was not seen by MD;
Within 30 minutes post vax, the pt developed a burning sensation in her sinuses. On 10/10/99, she developed left facial paralysis. She was seen by the physician and a dx of Bell's Palsy was made. The facial paralysis persists.
medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2022SA489108, 2022SA502558 and 2022SA503839.  This case involves a 14-year-old male patient who had medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event with yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine (Typhoid) and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) both for Prophylactic vaccination.  On 20-Oct-2022, the patient received suspect yellow fever vaccine at a dose of 0.5 ml total (lot UJ412AB, expiry date: 22-Nov-2025) via subcutaneous route in the left arm for immunization.  On 20-Oct-2022 the patient had a non-serious medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event (product preparation error, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.