chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive and confused (beyond baseline)
Upon approaching her 30 minutes observation time, patient stood up and felt dizzy. Patient assisted back to chair with legs elevated.  EMS evaluated. Vital signs obtained. Glucose checked by EMS. Drink provided to patient. Patient eager to go home and eat as she has not eaten since breakfast. Patient reports no longer feeling dizzy. Patient assisted back to car via wheelchair.
Sm. purple bruise at injection site & egg-size hard, reddened area below inj. site.  Area is warm to touch and tender when arm is moved.
Child was vaccinated on 4/17/01 at approx. 16:00. Mother states at approx. 20:00, the child complained of itching and a rash was noted on chest and back. Child was taken to PMD on 4/18/01. Per doctor's notes: fine papular rash on chest and back (light pink color). Treated with Rx Atarax. Mother states rash barely visible by day #3.
Fever, chills, and aches started around 1AM the night of the vaccination. Shortly after coughing, wheezing, shortness of breath, and dizziness began and lasted until about 8AM. It was severe enough that I almost went to the ER. But my rescue inhaler was helping to control the coughing some. This was by far the worst ~8 hours of my life. I have never felt anything like it, and I had Covid earlier this spring and it was not nearly as bad.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse event were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Rash on stomach/Rash trunk/rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on stomach/Rash trunk/rash) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, Psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE), Psoriasis and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash on stomach/Rash trunk/rash). At the time of the report, RASH (Rash on stomach/Rash trunk/rash) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.  It was unknown if the patient was enrolled in clinical trail.  Treatment information was not reported.
Pt. states that approximately 8 hours after vaccines both areas began to itch severely & become swollen & hard. Hot to touch - approximately 2-3 inches in diameter. BENADRYL given in clinic.
Community Health Office 11-month-old child was in for the second DTaP, IPV, HIB. The combination vaccine, PENTACEL, should have been used. KINRIX was given instead.
pt recvd vax & exp temp 104, was fatigued & sleepy & just did not feel well;
EPILEPSY, UNSPECIFIED 2/25/2022 ATHEROSCLEROSIS OF AORTA  GUILLAIN BARRE SYNDROME 12/13/2021 ATHEROSCLEROSIS OF AORTA  HYPOTENSION 10/28/2021 ATHEROSCLEROSIS OF AORTA  EPILEPSY, UNSPECIFIED 2/25/2022 ABNL BRAIN MRI  GUILLAIN BARRE SYNDROME 12/13/2021 ABNL BRAIN MRI  HYPOTENSION 10/28/2021 ABNL BRAIN MRI  EPILEPSY, UNSPECIFIED 2/25/2022 ALTERED MENTAL STATUS, UNSPECIFIED  GUILLAIN BARRE SYNDROME 12/13/2021 ALTERED MENTAL STATUS, UNSPECIFIED  HYPOTENSION 10/28/2021 ALTERED MENTAL STATUS, UNSPECIFIED
I was tired, then I got an awful headache, couldn't sleep.  Tired, nauseous when I moved,  No arm soreness.  It comes and goes.   I am a very healthy person and this is not like me.
so sick; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who was sick (illness), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient got the shot twice and both times he/she was sick and not had shot since then.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for illness was unknown.  There will be no information on the batch number for this case.
Patient was under 18 years of age when receiving the vaccination. The patient has since been checked in with and has had no adverse events following the vaccination.
a 29 month old patient received a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse practitioner reported a 29 month old patient received a dose of Kinrix., which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Pityriasis Lichenoides et Varioliformis Acuta  Occurred within 2 months of booster
Pt recvd vax & following inject pt exp numbness & tingling upper lt arm, face, & nose around lt eye;
This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown demography. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route and frequency was not reported) which was exposed to -5C for 14 days. The patients were also vaccinated with GARDASIL (dose, route and frequency was not reported), ROTATEQ (dose, route and frequency was not reported) and PNEUMOVAX23 (dose, route and frequency was not reported) which was exposed to -5c for 30 days. No adverse effects reported. Additional information is not expected.
Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; This is a spontaneous report from a non-contactable Other-HCP. This Other-HCP reported for a 43-year-old female patient that received second dose of bnt162b2 (BNT162B2, Pfizer COVID-19, Batch/lot number: EL0142), via Intramuscular on 05Ja2021 02:00 PM at single dose on Left arm for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products: Sulfas and first dose of bnt162b2 (COVID 19) for covid-19 immunisation. Concomitant medications were none. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Flu like symptoms like headache, chills, body aches from 05Jan202108:00 PM. No covid prior vaccination. No covid tested post vaccination. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Had red and hot mark extending down flu shot side to elbow out beyond. Patient told to call doctor, he said he had prior staph infection. (Patient called when I was off and would not return my calls for further info).
Localized redness, approx. 6cm in diameter area, warm to touch and toddler noted to scratch. Advised warm compresses and Tylenol every 4 hours, follow-up with our office if symptoms persist or worsen.
Mom brought pt back to MD office as pt had hives on trunk, arms, & legs; Most of body very reddened & warm to touch; pt c/o itching; DPH given;
Fever, diarrhea-hospitalized a/IV fluids/fever/ATB for 3 days; recovered completely;
5 days after shot developed pulling in both legs/developed into muscle fatigue in legs and in Rt arm. Restarted Celebrex 200 mgs which had discontinued for 7 days (Incl 1 day prior to shot)/added 2-4 Tylenol 500 mgs per day/ice/heat/exercises for shoulders/back/legs. Still experiencing symptoms 2 wks after started 3/18/21.
Patient, presented to clinic 4/10/17 for complete physical and immunizations. Pt returned to clinic today 4/13/17 due to (L) lateral thigh swollen and erythematous and plus or minus tendered; given cold compress, TYLENOL and MOTRIN as needed for pain.
This patient had swelling and pain of the left deltoid on 01/31/2001. Treatment with Benadryl and Prednisone.
This case was reported by a pharmacist via out of hour services and described the occurrence of injection site erythema in a adult patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist (Rph). The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. There was no redness or swelling for the patient after dose 1. The call was an AHVM (After Hours Voice Message) left by pharmacist on Sunday, 23rd September 2018 at 3:15 PM. On her message, she noted that GSK might contact the other pharmacist, who would be on duty the next day, 24th September 2018. A call back to the mentioned pharmacist was made, but there was no further information about the individual patients. This is 1 of the 5 cases, reported by the same reporter.
Redness, swelling, blisters. 5/22/06 mom called. Report child doing good no swelling, no blisters anymore, no problems.
Within 2 hours of vaccine administration, had metallic taste in mouth. At about 20 hours, left arm slightly sore, right arm very sore and worse with movement. 30 hours--weak, chills, no temperature, quarter size welt on right arm. By 40-48 hours, palm size arm, raised area on right arm. 68 hours - raised area from shoulder to elbow affected on right.
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 23-OCT-2012, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 10-SEP-2015, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Low grade fever (lasted 1day), severe body aches (lasted 1 month), severe headache (lasted apx 4 weeks), breakthrough menstrual bleeding has been ongoing 98% of the days ever since this second shot. Still not resolved.
Immunization led to relapse in nephrotic syndrome. Elevated protein levels in urine noted next day. Prednisone therapy began 14 days later. has not recovered fully. Biopsy, Prograf therapy, and strokes have resulted.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY
Works night shift.  Received vaccination at 7am - went home to sleep.  When awoke noticed that tips of both big toes were numb.  Numbness is intermittent but worsened with cold temperatures.
This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns an adult female patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed such a pain in her arm that she had to have a physical therapy to lift her arm, after pain continued for six weeks. The patient also developed shoulder pain. Outcome was not reported. Case linked to: 201404074325 (same patient).
SLEEPY; This spontaneous report received from a patient via a company representative . 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, intramuscular, batch number: The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sleepy was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Right after immunization patient looked pale and thought she was going faint. This was a near syncope event. Patient did not actually faint. Told her to lay on the ground flat with legs elevated. She was monitored for 30 minutes and felt fine after.
8 hours intermittent chills, sweating and fever, 4 hours vertigo (1 hour severe), 8 hours nausea, 24 hours headache and body aches and 48 hours swollen and painful right underarm lymph nodes.
Rash and hives to face and neck, cellulitis, abscess at site (L) deltoid, enlarged lymph nodes (L) neck and axilla.
Information has been received from a Registered Nurse concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). The Registered Nurse reported that 1 month after receiving the vaccine, the patient experienced chest pain. It was unspecified if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Left leg with 5 1/4 inch diameter erythema. Warm to touch, not tender. Painless lump approx 2 1/2 inch in diameter. Information received from the follow-up states that nodule remains and parent reported to provider that child has had 2 flares ups at the site described as " a bump with dots around it". These have faded within hours or overnight.
Around 2 to 3 minutes after vaccination, the patient was sitting on the bench outside the pharmacy and began to feel light-headed and tired. The patient's parent called me over, as he believed the patient had passed out. The patient was leaning on his parent with his eyes partially closed and did respond to questions. The patient did not lose consciousness and was A&O x3 (person, place, time) at all times. The patient lied down on the bench and after around 5 minutes, he felt well enough to sit back up. He was hungry so he was given a small amount of water and a snack and mentioned that the water made him feel better. After sitting on the bench for around 15 minutes after feeling better, he felt light-headed again and laid back down on the bench. The patient remained conscious the entire time and did not faint. I had him continue to lay down for around 10 minutes, and then he sat back up. After 30 more minutes, the patient had not experienced any other adverse events and decided to leave the pharmacy. The patient was advised to seek immediate medical attention if any symptoms returned.
This spontaneous report was received from a Registered Nurse referring to a multiple, unknown patients of unknown age and gender.  The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   In April 2017, reported as between 18-APR-2017 and 26-APR-2017,  the patients received multiple doses of improperly stored VAQTA invalid Lot #M005274 with and expiration date on 03-APR-2018 and Lot #M039202 with an expiration date on 11-MAR-2018 (strength, dose, and route of administration were not reported) for prophylaxis. The vaccines were stored at a Temperature of 47°F to 77°F during 84 hours. There was no previous temperature excursions and the call was not because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015668: US-009507513-1705USA015670:
Patient received Trumemba vaccine with 2nd dose of MCV4 on 6/15/23. Woke up on 6/16/23 at 5AM with NBNB emesis x 3 episodes. improvement in symptoms at 12PM, no further emesis, back at baseline.
Sore arm; Just little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and CHILLS (Just little bit of chills) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and CHILLS (Just little bit of chills). At the time of the report, VACCINATION SITE PAIN (Sore arm) and CHILLS (Just little bit of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.
Facial/body itching, redness of skin; itching decreased after Benadryl 50 mg was given. Went to ED.
CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine. Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day. Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities. Patient has not reported any adverse events to health clinic where error occurred.
Rapid heart rate.  Diagnosed as Atrial Flutter. Continued for weeks and resulted in treatment via medication and  cardioversion early December.  Heart rate back to normal at this time
fever, rash, droupy eyes, and experience "brain dysfunction". The child stopped walking, crawling, holding, grabbing, feeding herself, making eye contact or responding to everyday common responses. The child was observed by both parents and doctor to sit in the room and not interact or respond. This behavior continued for two months.
On March 4, 2021, a red rash appeared on my left arm at the injection site. It increased in size until it reached a size of 6 inches in each direction.  The rash has continuously  itched, ached, and slightly burned, with a pinching sensation  at times.  Borders of the rash were slightly raised as it spread. Rash felt slightly warm to the touch. Rash did not start to fade until March, 14, 2021, and area is still slightly visible today. The area on my left arm where the rash was still aches, slightly itches, and feels like a pinching sensation. Since the injection, I have felt some fleeting sharp piercing pains in various parts of my body (the worst was on the left side of my spine; another on my right toe and arch of foot:  and random "pins and needles" sensations. in other areas. Overall, I have felt sleepier than usual since the vaccine.
Chronic inflammation and joint pain. Lasted 4 months. Took Mobic (meloxicam) to relieve pain.
Employee started having fever after receiving the vaccine.  To date, employee is still feeling ill and seeing a doctor for care.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/06/2021. PATIENT FULLY VACCINATED ON 04/21/2021.
Received 12 month immunizations on 8/28/09. Next day presented to ER with temp 103.2 and seizures. Was hospitalized in PICU. Treated with ATIVAN, DILANTIN, VALIUM. Potential aspiration pneumonia after vomiting x 2. 9/24/09 Discharge summary received for date of service 8/30/09 to 9/3/09: Tactile fever noted by caregiver. Later arrived to ED via EMS in status epilepticus. Fever 103.2F, vomiting, chest congestion.  DX: Febrile seizures, status epilepticus. ICD9 codes: 345.3, 345.3, 348.39, 079.99
Had onset of headache which lasted at least 6 hr, also had fever of 99.9
Skin rash and swelling in arm with injection. Diphenhydramine 25-50 mg QID, methylprednisolone, acetaminophen/hydrocodone 5 mg other.