chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 07-NOV-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX lot # L029485, expiration date: 06-NOV-2016 (strength, dose, frequency and route were not reported. Concomitant therapies were not reported. No adverse effect were reported and no Product Quality Complaint was involved. Additional information has been requested.
patient c/o numbness of the fingertips of the R hand since last Wednesday, 4/28/2021. Denies any headache, nausea/vomiting, chest pain, dyspnea, dizziness, vertigo, slurred speech, weakness.  Patient received her 1st Moderna vaccine on 3/31/2021 on the left upper arm.  She received her 2nd Moderna vaccine on 4/28/2021 on the right upper arm. Her numbness symptoms started on Friday, 4/30/2021 just 2 days after her 2nd Moderna vaccine
Symptoms started approximately 1 hour after the vaccine was given, starting with weakness, chills, instability, needing help to restroom, poor appetite, vomiting, facial paralysis, tongue enlargement. Seizure occurred approximately 3 days later. These symptoms also went on for about 3 days before taking him to outpatient, and after 11 hours they discharged him with no clear answers. Then called PCP and was seen there, then ear, nose and throat doctor, then neurologist, then doctor, and PCP again. All of the doctors associated the symptoms and paralysis as an adverse event from the flu shot. Patient is still choking on medications and food due to tongue swelling and facial paralysis. Instability, weakness, and poor appetite are continued adverse events that have not resolved.
Fever over 104; Like I had the flu; Really sore; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Like I had the flu), MYALGIA (Really sore), PYREXIA (Fever over 104) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Birth defects (Birth problems). Concurrent medical conditions included Autism.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 05-Nov-2021, the patient experienced INFLUENZA (Like I had the flu). 05-Nov-2021, the patient experienced MYALGIA (Really sore). On 05-Nov-2021 at 7:30 PM, the patient experienced PYREXIA (Fever over 104). On 05-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 07-Nov-2021, INFLUENZA (Like I had the flu), MYALGIA (Really sore) and PYREXIA (Fever over 104) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: high (High) High,fever over 104.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  It was reported that was At 7:30 PM on 05-Nov-2021, patient had a fever over 104, felt really sore, and like he had a flu. This lasted for 2 days before resolving. He did not take any medications or treatments. He was considering calling 911, but did not. He has not spoken to a HCP about his symptoms.
Breakthrough case admission after 4 vaccines Pfizer 1/16/21 Lot# El0142;  Pfizer 2/6/21 Lot# El3248;  Pfizer 10/21/21 Lot# FE3590;  Pfizer 5/27/22 Lot# FJ4991
Pt developed rash that was sore and itching at injection site - continued to grow in size to 2 inches x 1 inch. Advised BENADRYL, ice.
All over my back, my butt, my legs; Itching; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, Lot: EL0140, Exp:Mar2021), via an unspecified route of administration on 21Dec2020 for first dose at single dose for COVID-19 immunisation. Medical history included blood pressure high and anxiety. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) for Blood pressure high and an anxiety medicine. The patient experienced itching there was nothing on 25Dec2020, in the morning of 26Dec2020, suddenly had rash all over back, butt, leg, she would like have the rash over body and she knew the reaction like the people like said it was within a couple of hours but this was more than couple of hours it is few days. At the time of reporting, no treatment received, she might go emergency to see if I get good dose of Benadryl. The event outcome was unknown.
pt recv vax & 3 days p/vax pt exp joint & stomach discomfort, bronchitis, h/a & felt lethargic;subsequently p/each bout of sx pt presented to MD who treated pt w/med;
Generalized patchy maculopapular rash with erythema anteriorly & posteriorly; Patient received Prednisone from Dr. (PCP).
Patient received Twinrix (Hep A/B) #2 on 8/29/06, 12-15 hrs after receiving shot, he stated he wound up in bed due to lack of energy. Denies nausea or vomiting. Stated he had minimal abdominal cramping. Is still lacking energy 7 days later.
FEELING DISORIENTED, VISION BLURRED, TINGLING, COLD SWEAT, AND THEN SLIGHT DIFFICULTY SWALLOWING
became positive on Tuesday; became positive on Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "became positive on Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: on Tuesday.  Additional information: the patient got his booster on Sunday as he had no symptoms. He became positive on Tuesday.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt states that she has left arm muscle pain at the injection site that has been there since the initial injection of the Shingrix vaccine on 09/08/2020. Pt states that it hurt to move her arm and is disruptive when she sleeps at night. Pt has not been seen by her provider for this arm pain. Pt was advised to contact her provider to discuss the pain she is experiencing.
Developed high blood pressure after having second booster shot of Moderna Covid vaccine. Started blood pressure medication on 11/22/2022.
Since the second vaccine, I've had a roaring sound in my right ear that comes and goes. I've never had this before in my life. I did take allergy medication afterwards and it did not help.
PATIENT DEVELOPED RASH ON ARM. PATIENT SAW DR AND WAS GIVEN A STEROID SHOT AND PRESCRIBED A MEDROL DOSEPAK TO COMPLETE AT HOME THAT WAS BROUGHT TO THE PHARMACY AND FILLED TODAY 7/9/21
Death on 05/04/2018 from unknown causes at this time. Vaccines given on 05/03/2018 in office.
pt recv vax FEB97 & 15FEB98 pt devel shingles on lt arm;
Following day after patient received vaccination, patient returned to the pharmacy and stated after the shot (approx 30 min after), pt reported that he had difficult seeing, talking, and his motor skills were impaired. Pt was home at time of incident. Pt spouse called 911 and pt was taken to emergency room. MD took several test too rule out seizure and stroke. Pt states he was at ER for approx 3-4 hours, and steadily improved at ER. Pt was released from ER for seizure-like symptom.
Patient reported muscle spasms starting 3/14/21 in evening, on 3/17 patient reported a red spreading area on arm below the site of injection. Patient sought medical help that day and initial diagnosis was possible cellulitis.
A third dose of Moderna was inadventently administered; there was no documentation of a second dose in the patient's chart or on his CDC vaccination card, and he did not think he had received a second dose.  A subsequent review of a hand-written vaccination log showed that he had indeed received a second dose of Moderna on 2/19/2021.
being dizzy; problem with seeing, my eyes are blurry and all of sudden when I look up all I see is stars; problem with seeing, my eyes are blurry and all of sudden when I look up all I see is stars; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "being dizzy"; VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "problem with seeing, my eyes are blurry and all of sudden when I look up all I see is stars".  No follow-up attempts are possible. No further information is expected.
Post viral symptoms 4 weeks post Influenza vaccine, increased difficulty ambulating x 4 weeks myalgias, neuropathies, evaluated by ER physician on 12/12/08.  2/5/09 Received ER medical records of 12/20/2008. FINAL DX: left leg pain Records reveal patient experienced difficulty w/weakness since 10/9/08 flu shot.  States had flu symptoms shortly after shot & had been having muscle ache of left leg since.  On 12/20 had muscle spasms & pain in left leg & it gave out, was unable to bear weight on left leg.  Neuro consult done & was WNL.  Tx w/meds & d/c to home.  Referred to Ortho.
Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Fever; Fatigue; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; Diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 44-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Apr2021 at 44 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fever, fatigue, shaking, pain and diarrhea in Apr2021 with outcome of not recovered. The patient reported severe headache, a fever and fatigue, not sure when he will get relief. The patient wanted to know when he will get some kind of relief. His headache was severe it feels like he was being hit on one onside of his head. He felt like it was shocking his body because of the pain all over, his body shaked because of the pain. He was surviving on Tylenol and Ibuprofen right now. The patient clarified having a maybe a little diarrhea along with the pain all over, fever, fatigue and severe headache.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Woke up with a 102.1 fever. Was extremely achy and feverish for 24 hours. 102.3 was the highest I recorded. There is also some swelling and warmth and redness around the injection site.
Severe muscle/joint pain starting at 7:00PM (starting in knees and ending in shoulder blades) and lasting until 12:00PM; chills starting at 10:00PM and lasting until 1:00AM; high fever 103.2; extreme tiredness the following day
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot on head and eyebrows) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced RASH MACULAR (Red spot on head and eyebrows). At the time of the report, RASH MACULAR (Red spot on head and eyebrows) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient confirmed it was not itching or burning and it was just there. There were no pre-existing condition and no allergic to many medications or food.
Pt received 1st dose of Moderna vaccine on 3/4/21 at 3:25 pm.  On 3/16/21 pt called office to report that she noticed this morning that a rash developed under the left arm.   Pt denies any itching, pain, swelling, heat or bumps.   Pt was referred to PCP.   Pt stated that she had already followed up with her PCP.
Patient has been experiencing radiating pain down her right arm when at rest as well as when extending arm or raising above the shoulder. She stated this began shortly after her vaccine was administered and is still on going. She followed up with her MD who is running some tests and performing imaging to determine the cause.
Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.  No concomitant medication was reported.
On 1/4 developed dime sized redness over vaccine site which on 1/5 enlarged with firmness, erythema and puritus.  On 1/6 developed swelling to antecubital area which was gone by 1/7.  On 1/7 developed erythema and petechiae to both upper arms.
A consumer report has been received concerning a 5 year old, male patient, Height: 43.0 inches. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medications included Diphtheria toxoid, Tetanus toxoid, whole cell pertussis vaccine and poliovirus vaccine live oral. Patient reported that 5 y/o son received FLUMIST QUADRIVALENT (intranasal) vaccination along with DTP and Polio vaccines on 22-Dec-2015. Consumer reports son's weight to be 43.5 lbs. Consumer reported that 3 hours after son received FLUMIST, DTP and Polio vaccines, on 22-Dec-2015, son had a red lump on his left cheek. Patient reported that the following morning, on 23-Dec-2015, son had another red bump on his right cheek and his right eye had a bigger lump that looked like a swollen eye on his upper eyelid all they way up to his eyebrow. The action taken with suspect drug was unknown. The outcome of the events of big lump on right eye, red lump on cheek and swollen eye was unknown. The company physician assessed the events of big lump on right eye, red lump on cheek and swollen eye to be non serious.
What I initially noticed was some problems with my vision. After trying to narrow it down, I was able to figure out that in the upper left quadrant of my field of vision, I had to blank areas. This persisted for about 15-20 mins and then it began to get better. After 30 mins, I was completely recovered. The blank areas were visible with both eyes, so I knew it wasn't a problem with the eyes. It was a brain problem. I went to the ER and they immediately took me in to run tests and observation. By that time, nothing showed up in the tests. They kept me all that day in the ER and then I spent the night on a bed in the ER. They kept me until early afternoon the next day. They moved me up to a hospital room. Finally they discharged me about 6:30PM.
got extremely sick; Initial information received on 10-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who got extremely sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for  prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got extremely sick" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Got a flu shot one time in my life and got extremely sick. So no I won't be doing that again."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got extremely sick).  At time of reporting, the outcome was Unknown for the event got extremely sick.
Information has been received from a physician concerning an 18 year old female with no known drug reactions/allergies who was vaccinated with Gardasil. Subsequently, the patient experienced dizziness, nauseous, starting to faint throughout the evening and pale. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from dizziness, nauseous, starting to faint throughout the evening and turned pale. The product quality complaint unit was not involved. No further information is available.
Parent called to inform me that child was seen at Childrens ER due to leg area being swollen. ER report enclosed.
POSSIBLE GUILLAIN BARRE SYNDROME SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the subject experienced possible guillain barre syndrome symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible guillain barre syndrome symptoms was not reported. This report was non-serious.
COVID-19 infection/Covid-19 positive; COVID-19 infection/Covid-19 positive; This is a spontaneous report from a contactable physician (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received her first dose on 12Jan2021. She developed COVID-19 infection two weeks after receiving the vaccine in Jan2021. The lab data included Covid-19 positive in Jan2021. The outcome was unknown.  Information about batch/lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
just slightly feverish and soar muscle for 10 hours after 1 day of injection . injection site at arm soar after 1 day
HPV #1, 8/18/08; HPV #2, 10/20/08; HPV #3, 3/3/09. Hospitalized within 2 weeks of each vaccine for severe depression exacerbation.  3/23/09 Received PCP vaccine records & medical records of 8/18/08-3/17/2009. FINAL DX: OCD, depression, suicidal ideation Records reveal patient experienced good health on 8/18/08 when received HPV #1.  RTC 10/20 s/p hospitalization x 2 wks for depression & was continued psych meds & care.  Had nasal congestion, HA & sleep disturbance x 3-4 days.  No dx provided & received HPV #2.  RTC 3/3/09 w/rhinitis, cough, fever x 4 days.  Dx w/viral URI & received HPV #3.  3/26/09 Received multiple ER medical records:  9/5/2008 ER visit FINAL DX: Depression w/suicidal ideation Records reveal patient having SI.  Meds given for UTI.  Psych eval in ER & transfer to psych hospital.  11/8/2008 ER visit FINAL DX: Depression w/suicidal ideation Records reveal patient w/SI x 1-2 wks.  Psych eval in ER & transferred to psych hospital.  3/10/2009 ER visit FINAL DX:Depression w/suicidal ideation Records reveal patient w/SI intermittently since 11/08, on multiple psych meds & seeing psychiatrist 2x/wk & was in outpatient program.  Had dx at psych hospital recently of depression, OCD & anxiety disorder.  Had 30# wt gain w/increased appetite.  Parental divorce in process.  Psych eval in ER & transferred to psych hospital.  3/16/2009 ER visit FINAL DX: Depression w/suicidal ideation Records reveal patient w/SI & plan for self harm, racing thoughts, insomnia.  Psych eval in ER & transferred to psych hospital.  4/6/09 Received D/C summaries for 3 admissions: 9/6-9/17/2008 Final dx: OCD; major depressive disorder, recurrent. Records reveal s/s had been progressing since summer w/suicidal ideation, anxiety, panic attacks, OCD repetitive behaviors.  Initial psych hospitalization.  Parents had separated 1 yr prior & had multiple family/friend losses.  Required constant attention while hospitalized due to anxiety.  Tx w/multiple meds as well as psychotherapy.  Slowly improved & d/c to home on continued meds & w/outpatient therapy.  11/9-11/16/2008 Final dx: major depressive disorder, recurrent; OCD. Records reveal patient had initially done well s/p hospitalization 9/08 then gradually began to have recurrent s/s that increased severely 4 days prior to admit w/suicidal ideation.  Had been seeing therapist weekly & was on meds.  Meds adjusted & changed.  Improved & d/c to home on continued meds & therapy.  3/11-3/14/2009 Final dx: major depressive disorder, recurrent; OCD; panic disorder w/agoraphobia. Records reveal patient had attended partial hospital program for couple of mo & had done OK but depression, anxiety & SI returned.  Having academic & social difficulties.  Gained 35#.  Meds adjusted.  Slowly improved & d/c to home w/continued meds & therapy.
04/14/2022 0835: Patient vaccinated with Pfizer and HPV #2. In a few minutes child stated feeling lightheaded. Parent stated that child had breakfast today. 0837: Seated in semi recliner and offered apple juice. Tolerated it well. 0845: Child stated feeling much better. Walked with parent to be seated in waiting area for the observation time. On her way she looked pale and disoriented. Made her sit in chair and lower her to the ground and raised feet. Called Rapid Response. BP: 100/57 Pulse 70 o2 sat 97%. Patient become alert and responsive. 0852: BPX2 done lying, sitting and standing. 0855: Parent given choice by team to be taken to ER or go home if feeling better. Child stated feeling better. Parent advised to go ER if any issues at home. 0910: Patient went home accompanied by parent.