chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT WAS A HEALTHY, HAPPY, THRIVING, ADVANCED INFANT MEETING ALL OF HIS MILESTONES, CRAWLING,SITTING, AND STANDING. NEVER SICK. HE RECEIVED HIS VACCINES ON 09/10/2008 ON 09/13/2008 MOTHER NOTICED PATIENT WAS NOT ACTING NORMAL, SEEMED TO BE OFF BALANCE, WOULD STARE FOR AN EXTENDED PERIOD OF TIME, AND WAS FUSSY. SHE NOTICED HE WOULD PULL AT HIS RIGHT EAR IT WAS THE WEEKEND, SO SHE GAVE HIM TYLENOL FOR THE DISCOMFORT HE SEEMED TO BE IN. SHE TOOK PATIENT TO THE DOCTOR ON TUESDAY, SURE IT WAS AN EAR INFECTION. UPON DOCTORS EXAMINATION SHE ADVISED MOTHER TO TAKE HIM TO THE HOSPITAL. MOTHER TOOK HIM TO MEDICAL CENTER WHERE THEY PERFOMED A CT-SCAN OF THE BRAIN ON PATIENT. SHE WAS TOLD HIS BRAIN WAS SWOLLEN AND THEY AIREVACTED HIM TO  HOSPITAL WERE HE STILL REMAINS. SINCE HIS HOSPITALIZATION PATIENT HAS BEEN THROUGH A SERIES OF MRA'S MRI'S BLOOD WORK (ETC) HE SUFFERS FROM SEIZURES, SWELLING OF THE BRAIN, STROKES, AND NUMEROUS BRAIN LESIONS. WITH NO DIAGNOSIS OR PROGNOSIS FROM THE DOCTORS, THEY ARE UNABLE TO GIVE US A DIAGNOSIS. THEY ARE TREATING HIM WITH IV METHYLPREDNISONE, AND PHENOBARBITAL. THE FACTS ARE AS STATED ABOVE PATIENT WAS HEALTHY AND HAPPY PRIOR TO THE VACCINES.  10/15/2008 Reviewed hospital medical records of 09/18-10/03/2008. FINAL DX: multiple posterior fossa infarcts; ataxia; new onset seizures x 1 episode Records reveal patient experienced fall 5 days prior to admission hitting left side of head.  Two days prior to admission had intermittent episodes of poor balance, veering & falling to the left, decreased resonsiveness, abnormal behavior.  One day prior to admit, seen by PCP & sent to ER where CT scan reveled right cerebellar contusion.  Neuro, ID & Heme/Onc consults done & admitted to PICU.  DTRs quite exaggerated in LEsTx w/steroid taper.  Had possible seizure x 1 min w/eye/head deviation to right & postictal sleepiness.  Loaded w/Pb & steroids increased & tapered again.  Progressed slowly.  D/C to home on ASA, steroids & Pb w/PT & ST referrals.  10/3/08 Reviewed ER medical records of 9/17/2008. FINAL DX: right cerebellar contusion Records reveal patient experienced balance difficulty & fall from approx 3 inch step 4 days prior.  Left eye ecchymosis noted.  Excessively sleepy on day of visit w/increasing difficulty w/balance & left sided weakness. Transferred to higher level of care.
Pt with local reaction to pneumovax measuring 3.5cm wide by 5.5cm long on the R deltoid. Area is erythematous, warm and tender to touch. Sx began approx 3 hrs after vaccination. Pt has not tried any ice therapy or otc meds. Local reaction to Pneumovax. Ice to area, ibuprofen or motrin time 3 days. F/U in 2-3 days if not resolved. For subsequent pneumovax - follow pre treatment protocol. Temovate cream to injection site prior to vaccine.
sore throat; was kind of lethargic; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LETHARGY (was kind of lethargic) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), LETHARGY (was kind of lethargic) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LETHARGY (was kind of lethargic) and HEADACHE (headache) outcome was unknown.            Concomitant medication information was not reported  Treatment information was not reported
3cm indurated erythema with pain at injection site. Seen at doctor visit, 10 days later.
Narrative: COVID infections following completion of COVID vaccine series 03/19/21 COVID vaccine dose #1 04/12/21 COVID vaccine dose #2 04/30/21 Pt reports to ENT for nasal congestion - treated with steroid pulse 05/10/21 Pt reports to allergy for evaluation of nasal symptoms; reports diminished smell 07/21/21 Pt reports dry cough that is occasionally productive with yellow sputum, loss of taste/smell with hx of allergies x2; reports household diagnosed 07/20/21; swab performed - COVID POSITIVE 07/22/21 Pt reports cough, headache, muscle pain
drying vesicle lesions, approx 20-30;dx chickenpox, probably vax failure, came to MD office 15MAY97;
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. Patient's pertinent medical history and drug reactions/allergies were not reported. Pharmacist stated that a physician's practice informed her that they may have administered a dose of PROQUAD (Merck) to a patient on 05-FEB-2016 (reported as "today") that expired on 05-DEC-2015 (lot number unspecified) (expired product administered). The outcome was unknown. The pharmacist was not in the location where the expired dose was administered, so she did not have access to any other details surrounding this event. She was not aware of any adverse effects. No product quality complaint was involved. Additional information has been requested.
Arm is swollen and it itches.  site of the vaccine is hard and its inflamed large hard nodule at injection site.   warm, painful, bruised
1. Site of injection: vesicular cluster on 8/22/06.  2. Generalized vesicular eruption (20 lesions) onset 8/23/06, no systemic illness.
Patient Contracted COVID-19  Patient Died from COVID-19 on 10/09/2021
07/17/2003: Immunizations. 07/19/2003: Right arm swelling, slightly itchy
Patient said she has the rash under her armpit.  The size is around 2-3 inches. It is red, swollen and painful.
T105.2 R 2 hrs p/vax; APAP given q 4 hrs; listless; t103.0 R p/sponge bath; irritable; eyes glazed; aches all over; scream when touched; high pitched cry 14APR92 PM t98.2 @ 2PM 15APR92 t101.0 10PM 15APR92; Pt taken to hosp 15APR92 & kept;
pt recvd vax; exp induration at inject site for 3 days p/ vax;
Patient tested positive for Covid-19; Patient tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A  non-pregnant 40-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and then dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE,  for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient tested positive for COVID-19 via nasal swab on 30Aug2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the adverse event was unknown. Facility type vaccine was at a hospital. The outcome of the event was recovering at the time of reporting.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient received Moderna COVID vaccine on 2/27/21 (lot # 002A21A), 3/27/21 (lot # 026B21A), and 10/30/21 (lot # 014F21A).  On 12/28/21, patient tested positive for COVID. On 12/29/21, patient admitted to our facility med/surg unit for acute hypoxemic respiratory failure and pneumonia due to COVID-19 and uncontrolled diabetes type 2.  Patient was provided with remdesivir for 4 days. On 1/2/22, patient decided to leave the hospital AMA (against medical advice) after a thorough discussion of risks of leaving the hospital.  He declined oxygen therapy at discharge. He was sent a prescription to complete his course of Dexamethasone in an attempt to improve his tenuous respiratory status (the risks of worsening respiratory decompensation are greater at this time to his life than elevated glucose that may result from steroid use).
On 11/15/09 I noticed a rash on my childs face, arms and legs. On 11/19/09 my son was seen by his physician and a heart arrythmia was identified. My child has now been referred to a cardiologist and an allergist.
Had second dose on Saturday; headache and body aches the rest of Saturday and Sunday. Monday just body aches. Tuesday around 12:30pm during lunch break felt like I had something in my eye. Pulling out white stringy stuff and about 20 mins after initial feeling my eyes were nearly swollen shut, felt like lots of sand in my eyes, and a headache. I do not have any food or seasonal allergies, only allergy to sulfa.
Excessive sweating; Swelling on lymph node (right side); Pain and Soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Excessive sweating), VACCINATION SITE LYMPHADENOPATHY (Swelling on lymph node (right side)) and AXILLARY PAIN (Pain and Soreness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Apr-2020. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 09-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling on lymph node (right side)) and AXILLARY PAIN (Pain and Soreness). On 11-Jan-2021, the patient experienced HYPERHIDROSIS (Excessive sweating). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Jan-2021, AXILLARY PAIN (Pain and Soreness) had resolved. At the time of the report, HYPERHIDROSIS (Excessive sweating) and VACCINATION SITE LYMPHADENOPATHY (Swelling on lymph node (right side)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2020, SARS-CoV-2 antibody test: unknown (Positive) Unknown. In December 2020, SARS-CoV-2 antibody test: unknown (Positive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took her second dose on 06 Feb 2021.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03 Jun 2021 contains significant information such as added medical history, lab data and concomitant products .Updated reporter information and patient demographics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
12:20 given vaccine on 1/27/21 12:29 began to leave, felt dizzy  12:30 parked in vehicle at vaccination location I had sharp pain in center of chest, heart was racing, I saw hives on my chest, neck, throat and up to my mouth. My lips were getting numb. I was confused and unable to participate in a work phone call I answered.  12:45 I began driving as I felt a little better. Drove 2 miles and pulled over to park and wait it out. Heart still racing, hives still present, chest pains still there and could not inhale deeply.  12:50 I drove the rest of the way home. I took a double dose of liquid Benadryl and laid down waiting for symptoms to pass. They slowly resolved over the next 6 hours.  It is now 1/30/21 and I still feel like crap, but not allergy wise. More like the flu.
Pt received vaccine on 11-9-15. Severe swelling, red and hot x 10 days. Itching and "bumps" thereafter. 12/1/15-> red and scabbed and "hurts way down in the arm" and "hurts to lay down on it at night".
Developed pain, ringing, and popping in left ear about 5 days after first dose. Symptoms have remained the same since.
Immunizations given at 0845, she screamed from 12:30-2:45/pm. Her foot was purple with red spots.
Chills, Headache, Nausea, Fatigue, general malaise, Arm Pain.  I did not go to work the day following the vaccine because I felt so bad.  I took APAP and Ibuprofen routintely x 48 hours to help with symptom relief.
Pt rec'd 6 immunizations. Waiting for the 15 minutes with his sister. He saw her get dizzy as nurse sat her into chair, then he fainted, bumped his head on the sheetrock wall, his father partially caught him helped to floor. Not unconscious at anytime. Kept him on floor flat until recovered. Father decided he was okay. Used foreign lang line to converse.
Mastitis of the left breast which is the arm I received the vaccine.  My PA treated me with a course of antibiotics. Follow up with my breast doctor at local Women's imaging Center two months later with mammogram and ultrasound was normal
has pain, tingling, numbness in arm during and immediately after injection pain radiating down arm and continued after dosing with ibuprofen 400mg and massaging  3 hours later patient states pain in shoulder recommended seeing physician if pain continued after medication and ice she stated if not better tomorrow she will see physician
This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H018691 exp. date 07-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211; 1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012231; 1309USA012232
This spontaneous report has been received from the patient's father referring to a 16 year old male patient. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant therapies included PROZAC. On 02-MAR-2018, the patient was vaccinated with the third dose of GARDASIL 9 (strength, anatomical location, route, lot number and expiration date were not provided) for "prevention of HPV". It was reported that immediately after vaccination, the patient was complaining of soreness at the injection site, additionally, some of the vaccine was draining from the injection site and the patient's coat was wet. Although the patient sought medical attention, none treatment was given and none laboratory studies were performed. The outcome of injection site pain was reported not resolved. The outcome of injection site discharge was unknown. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL in 2011 (dose, route, site of administration and lot # not reported). The reporter stated that in 2012, the patient received the second dose of GARDASIL (dose, route, site of administration and lot # not reported) well outside the recommended interval between the first and second dose. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician concerning an 8 week female patient with no pertinent medical history reported who on 13-JUL-2009 was possibly vaccinated with a dose of PNEUMOVAX 23 accidentally. It was reported that late on 13-JUL-2009 the physician was doing dictation and noticed that his nurse had signed out the PNEUMOVAX 23 instead of another similar sounding vaccine which had been intended for this child. No relevant laboratory testing had been performed. It was unknown if the child will receive any more PNEUMOVAX 23 and the child's father reported that she was showing no adverse effects from this event. Additional information has been requested.
Patient was given a dose of Fluzone MDV from a vial that was at 18.6 C for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144005, 2019SA144006, 2019SA144008 and 2019SA144005. (same reporter).  This case involves a 13 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (1st dose this year).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AE and Exp. Date 30-Jun-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
We don't know when the rash actually started on his chest and back but we noticed it around 8pm that same day. We gave him an allergy pill but that didn't really help. We saw an Allergist (6/30) and he mentioned, it wasn't hives but that he would need to research if he could get another shot based on the reaction. After this weekend, Patient said his back would sting when he would get hot so I called back the doctor. On Wednesday, he prescribed Triamcinolone Acetonide Cream. We have used it once so far and Patient's back does look a little better but the rash is still there.
Med Error:  An empty syringe with 0.5 ml of air was inadvertently administered into the left deltoid instead of the Moderna COVID-19 vaccine. The RN giving the medication disclosed the error to administration and to the patient.   The patient was called back to receive the dose of Moderna as planned that same day.   Writer is not aware of any adverse reaction due to the medication error.
fever/ 101 fever; very hot; dizziness/ dizzy; Diarrhea; can't even see straight; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 05Apr2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) as single dose for COVID-19 immunization. Medical history included breast cancer diagnosed about a year ago and it was not ongoing and lung cancer diagnosed 15 or 20 years and it was not ongoing, it stopped 20 years ago. Patient took a lot of medications. Patient stated she experienced every single side effect listed including fever and dizziness after receiving the first dose of the Pfizer COVID vaccine. Patient stated was it possible that she had COVID-19, she had a 101 fever (07Apr2021), diarrhea (05Apr2021), was very hot (07Apr2021), dizzy (06Apr2021), and had everything that was on the paper. Patient stated she had a fever and couldn't even see straight (Apr2021). She had diarrhea from 05Apr2021, 06Apr2021, 07Apr2021, 08Apr2021 and still has it. Stated it was bad and had to throw underwear out, that's how bad it was. Stated she started feeling very hot last night 07Apr2021 and it was the same. When she got up she was dizzy and that had stayed the same. Patient stated she hasn't used anything for treatment. Outcome of the events was not recovered. No investigation assessment.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse via a company representative refers to a 69 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were unknown. On 25-MAR-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously from batch/lot # 01097Y (dose, and expiry date unknown). On 29-NOV-2012, the patient developed shingles. She sought medical attention from a nurse practitioner and received an unspecified treatment for the event. The outcome of shingles was unknown. Causality was not provided by the reporter. No product quality complaint was involved. Additional information has been requested.
Caller stated that he had "2 nose bleeds"; heart skipped a beat and stuff/beat 2-3 times and then skip a beat, then continue to beat again; it does it all the time but seemed to get worse; heart skipped a beat and stuff/beat 2-3 times and then skip a beat, then continue to beat again; it does it all the time but seemed to get worse; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunisation. Medical history included "heart skipped a beat". The patient's concomitant medications were not reported. On the 13th day after the first dose (Feb2021), the patient experienced his "heart skipped a beat and stuff". The patient stated that he had 2 nose bleeds and his heart would "beat 2-3 times and then skip a beat, then continue to beat again; it does it all the time but seemed to get worse". The patient wanted to know if he can proceed to the second dose. The patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 22Jan2021 and is scheduled for second dose today, 12Feb2021 at 4:45. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
chills in my left and right arms; lymph nodes in injection site arm feel painful; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills in my left and right arms) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in injection site arm feel painful) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills in my left and right arms) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in injection site arm feel painful). At the time of the report, CHILLS (chills in my left and right arms) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in injection site arm feel painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Patient was given a 2nd booster dose of 0.25ml.  Patient had been administered a 0.25 ml dose in Nov 2021
Pt was given HAVRIX 1 on 2/5/19 and the next day, 2/6/19 woke up with red rash on face that was itchy and swollen. Rash goes away after 30-60 mins and then will reappear usually after patient has been sleeping. Advised to give zyrtec  liquid 1/2 tsp twice daily.
First day - onset of fatigue; soreness at vaccination site; slept 9 hours that night Second day - continuing soreness; fatigue Days 3, 4, 5 - soreness gone, fatigue and sleepiness continue; mildly elevated temperature - about 99.5 or 99.6F
Caller describes "bites" on both legs beginning 6 days after vaccination, starting on her ankles. Visited urgent care over weekend; prescribed mupirocin, famotidine, prednisone & sulfa/trimeth. Of note, caller reports having rescue animals in the home. Yesterday saw PCP, no new scripts provided. Advised to continue taking meds as prescribed & follow-up with PCP.