chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spontaneous hives every day, multiple times a day, on feet, hands, and arms. Sometimes neck. Mostly feet.
Information has been received from a registered nurse (R.N.) concerning a female who was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a rash. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Right side of face numbness, then migrating over to numbness to left side of face, then forehead.
elevated liver enzymes; elevated LDH; This case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a adult female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 days after receiving SHINGRIX, the patient experienced elevated liver enzymes and lactate dehydrogenase increased. On an unknown date, the outcome of the elevated liver enzymes and lactate dehydrogenase increased were unknown.   It was unknown if the reporter considered the elevated liver enzymes and lactate dehydrogenase increased to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's husband. The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX vaccine and 12 days post shot had bloodwork with elevated liver enzymes and elevated lactate dehydrogenase. The reporter consented to follow up.
fainting episodes; This spontaneous report was received from a registered nurse via a sales representative and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2021 (reported as in the past 4 to 6 months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (injection site, lot # and expiration date were not provided) for prophylaxis.   On the same date right after the injection, the patient experienced fainting episode. The patient was kept in the clinic for a while, recovered, and was sent home. It was reported the patient sought medical attention but it was unknown if any treatment was given.   The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of fainting episode was considered to be medically significant.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA007327: US-009507513-2107USA007555:
This report described the occurrence of renal insufficiency in an adult female patient who received ENGERIX B vaccine. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient's medical history, concurrent conditions, and concurrent medications were not reported. On 11/5/03, the plaintiff's attorney alleged that on an unspecified dates the patient received vaccinations of ENGERIX B vaccine and experienced medical problems, including severe renal disease and compromise, and Plaintiff's resulting death. These events required hospitalization. Follow up on 11/26/03: "Staphlococcal endocarditis."
Pt vaccinated with DTP and developed convulsion, high pitched cry, prolonged crying spells x 72 hrs.
09/30/2021-10/04/2021. 6-7 hrs. after vaccination awoke feeling like a truck hit all of my insides, organs hurt, bones and muscles hurt, feverish, chills continued for 4 days. Slept for 2 days. No stomach, runs, etc. issues. Temperature from 99.7-102.1. Awoke 10/02/2021 with heart racing, pounding and thought it was going to jump out of my chest. There was tingling sensation moving down my arms to mid-shin area. Hands were splotchy blue, later just the palms.
Narrative:  COVID infection following COVID vaccine series 03/01 Janssen, dose #1 (non-agency) 08/07 pt cc: diarrhea, dyspnea, exposure: unknown 08/09 pt admit non-agency hospital dx: covid-19 pna LOS: 9 days 08/23 COVID swab, result: detected
After his injection, the patient was in the waiting area and described a new taste in his mouth. He described it as a "medicine" taste. He said it wasn't there until he received the vaccine. I examined his arm for redness, swelling, signs of a reaction. There was none. I also screened him for symptoms of anaphylaxis and he had none. I checked on him several times and before he left, he said the taste was "better" and said he had no other symptoms.
Patient noticed a rash that started on his left arm on 11/20/2021, which eventually spread to his right arm.  Rash was not on his chest or back.  He did not seek medical care.  Recommended f/u with PMD at time of patient report.
First few days, sore arm , mild HA.  Then next few days arm was better.  Then on day 7 I began feeling a deep itching sensation in deltoid muscle, went to bed and woke up on day8 and area of redness, warmth, swelling on the deltoid and aching pain down the left arm.  Tingling feeling in left hand.  Showed to boss when I went into work and he had me seek medical evaluation
Patient noted erythematous blotches on upper anterior thighs.  Not itching.  The next morning round, erythematous patches developed on posterior aspect of upper arms.  Not itching.
I got the anthrax shot in my Left arm at 9am on 9/9/2017 and by 4pm on the same day I noticed my arm had began to itch. The next day my arm had begun to swell and was hot to the touch. Also the area in which was the injection site was hard or stiff and bruised.
Pt's mother insists that the baby developed a sudden onset of chest cold, caughing and slight fever the day following immunization which lasted for 2 weeks. Contacted his doctor for his report because mom insisted that the doctor said the baby's illness was related to immunization. The doctor has no record of a visit or an EOR visit either.
This case was considered medically important for the event of febrile seizure. Information regarding Prevnar was received from the father of a male child who received a dose on an unspecified date in 2002 or 2003. Within one month after receiving his last dose of Prevnar, the patient experienced febrile seizure. In 2006, the child began to experience trouble focusing. "No relevant history; no seizure prior to Prevnar; no family history of seizure." The patient's father reported that past vaccine therapies received by the patient included: "all recommended" vaccines, "according to schedule" (dates unspecified.) Indication for Prevnar was immunization. Product was administered on an unspecified date in 2002 or 2003. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in 2002 or 2003, the patient received the last dose of Prevnar. Within one month after receiving Prevnar, the patient developed a "high" fever and lost consciousness (date unspecified). On the way to the emergency room, the patient regained consciousness. The patient was observed in the emergency room and had blood work done. The emergency room could not find a cause for the loss of consciousness and released the child. At a follow-up visit to the pediatrician, on an unspecified date, the child was diagnosed with febrile seizure (febrile convulsion). Approximately one month later, the patient experienced a second febrile seizure with loss of consciousness.  A neurologist evaluated the child and found no cause for the loss of consciousness, agreeing with the diagnosis of febrile seizure. On an unspecified date in 2003, the patient began Trileptal (oxcarbazepine) therapy. Between Nov 2004 and Jan 2006, the patient did not experience any seizures. On an unspecified date in Jan 2006, Trileptal was discontinued. On an unspecified date in Mar 2006, the patient experienced a seizure with loss of consciousness. According to the reporter, since the first seizure, the patient experienced approximately ten similar episodes. In 2006, the child started school and his teachers reported that the patient had "trouble focusing" (disturbance in attention). The reporter noted that the child does not follow "simple directions." As of 27 Mar 2006, the patient had not recovered from the events.
Tightness in airways noted after 2 days from second dose.; This is a spontaneous report from a contactable Nurse reporting for herself.  A 36-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284, expiration date unknown) intramuscular (arm left) on 22Jan2021 (12:45 AM) (age at vaccination of 36-years-old) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1824, expiration date unknown), intramuscular (arm left) on 04Jan2021 (12:45 PM) (age at vaccination of 36-years-old) at single dose for covid-19 immunisation. The patient experienced tightness in airways after 2 days from second dose on 24Jan2021, 12:00 AM; no hospitalization required. No treatment was administered in response to the event. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination the patient has not been tested for COVID-19. Outcome of the event was recovered on an unspecified date.    .
Rash, inner thigh, both legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Feb2021 at 10:30 (at the age of 64 years old) (Lot Number: EL9267, unknown expiration) as 1st dose, single for COVID-19 immunisation.  Medical history included pre-diabetic and high cholesterol. No known allergies. Concomitant medications included rosuvastatin and metformin.  The patient experienced rash, inner thigh, both legs on 20Feb2021 at 20:00. The patient did not receive treatment for the event. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. No other vaccine in four weeks. The patient had not yet recovered from the event.   Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD (lot # M010478, expiration date 01-SEP-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt became pale, turned blue around mouth & passed out @ clinic p/shots; no sz, LOC only for few seconds; In clinic pt again became pale & limp but no LOC;
Patient was 16 yo at first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received and contains non-significant information
This spontaneous report was received from a registered nurse referring to a patient of currently 17 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
burning, tingling of b/l UE and LE,  progressively worse and also occurred on other areas of his body, no weakness, no rash or numbness.
Patient collapsed at the counter, he was helped to the ground, he was asked to lie flat for 10 minutes.  After 10 minutes he was able to sit up and he felt a lot better. After 30 minutes he was fine.
Patient fainted and fell on the floor briefly after flu shot with stiff body and jerking movements. Patient regained consciousness after 10-15 seconds
Covid19 breakthrough.  Pt vaccinated on 03/12/2021.  72 y/o PMH CAD s/p CABGx3, HF, HTN, HLD, DM admitted from home via EMS for c/o AMS, Respiratory distress and fevers.  EMS found pt hypoxic with O2 sat's in the 30's, bagged on route to ER and Intubated upon arrival.  T-105.  Pt started on IV ABX/Steroids and Remdesivir.
CHEST PAINS STARTED WITHIN 18 HOURS ER ADMISSION 24 HOURS AFTER ADMINISTRTION DX WITH INFLAMMATORY REACTION TO FLU SHOT
the patient reported having a flare up or increased bothersome abdominal and bowel symptoms over the past month and rated his abdominal pain as an 8 out of 10. the patient reported that he and his doctor believe his flare up was cause by the second dose of the moderna covid-19 vaccine. he experienced severe inflammation following the second dose of the vaccine and went to the hospital (unknown dates,length of stay). the patient was given steroids to treat the inflammation. the patient reports that he is currently on prednisone taper for ongoing inflammation and is feeling much better. the patient reports that the stelara prescriber is aware of all of the above and does not feel that the flare up was due to stelara and wants the patient to continue stelara. the patient reports that he feels comfortable continuing stelara as well. no further information provided.
Heart is racing; High Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart is racing) and HYPERTENSION (High Blood Pressure) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ATENOLOL, AMLODIPINE and LOSARTAN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PALPITATIONS (Heart is racing) and HYPERTENSION (High Blood Pressure). At the time of the report, PALPITATIONS (Heart is racing) and HYPERTENSION (High Blood Pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
local Rx (R) thigh edema, erythema, warm, no tender 6 1/2" by 5 1/2"
Administered on 4/9 Jenssen. On 4/14 patient daughter complained mother had a red itchy rash on bicept and on legs and ankles (red, bumpy, and itchy). Patient instructed to take benedryl and to contact primary care doctor. Pharmacy and Patient contacted doctor.  RX medrol dosepak prescribed to picked up.  Patient's rash resolved.  Family thinking this was related to the vaccine since patient had not tried any other meds nor was outside.  Doctor did not think was related to Vaccine per patient's daughter. Filing Voluntary VAERS to report rash 5 days later.
Red rash and swelling at injection site. The red rash and swelling with pain to touch lasted until Feb 8. then the arm was still slightly swollen and currently black and blue
He states that he started having fatigue on 9/7. He went to his PCP for COVID test and was positive on 9/8. Symptoms progressed to productive cough, fever, emesis, and body aches. He stated that it has been progressively more difficulty to stay hydrated. He endorses having Moderna Vaccine x2 second dose in May 2021.   Course: Patient presents with breakthrough COVID-19 Pneumonia. Will continue dex, start Baricitinib, and hold Remdesivir given LFT and AKI. Patient has numerous risk factors for COVID-19 syndrome including Obese, Male, Elderly, COPD, CAD, CHF, Lung Cancer history, and OSA. Patient expresses desire for no intubation but wants CPR attempted. Saturation goal will be > 88% and he is currently on HFNC.
benign fasciculation; twitching in the abdominal area / feeling like a baby moving; achiness; tiredness; sore arm; This case was reported by a consumer via call center representative and described the occurrence of fasciculation in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 2nd October 2019, refer US2020252579), Shingrix with an associated reaction of pain in extremity (1st dose received on 2nd October 2019, refer US2020252579), Shingrix with an associated reaction of fatigue (1st dose received on 2nd October 2019, refer US2020252579) and Shingrix with an associated reaction of pain (1st dose received on 2nd October 2019, refer US2020252579).   On 3rd December 2019, the patient received the 2nd dose of Shingrix (intramuscular). In December 2019, less than a month after receiving Shingrix, the patient experienced fasciculation, muscle twitching, general body pain, tiredness and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fasciculation was not recovered/not resolved and the outcome of the muscle twitching, general body pain, tiredness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fasciculation, muscle twitching, general body pain, tiredness and pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced a sore arm, achiness and tiredness which resolved.  In late December 2019, the patient reported twitching in the abdominal area, described as feeling like a baby moving. She was seen by a neurologist who did an EMG (Electromyogram) and NCS (Nerve Conduction Studies).  The patient was diagnosed with benign fasciculation, which was present at the time of reporting, and only became apparent with dose 2 and not dose 1. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252579:same reporter
Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a contactable pharmacist, the patient.  A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 17Dec2020 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization.  Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced acute pancreatitis with sepsis, which were reported as serious for hospitalization and being life threatening. The patient had gone to the emergency room due to the event and was hospitalized for a total of 6 days.  On 29Dec2020 and 31Dec2020, the patient had COVID-19 nasal swabs performed and both results were negative. Therapeutic measures were taken as a result of acute pancreatitis with sepsis and included gall bladder removal. The clinical outcome of acute pancreatitis with sepsis was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events pancreatitis with sepsis with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced unspecified adverse event. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20220638820.
Patient had hemorrhagic vitreous detachment, retinal tear.  Treatment was laser surgery and rest. Outcome was back to normal.
Breakthrough case admission after 2 vaccines Pfizer 3/22/21 lot# ER2613;  Pfizer 4/12/21 lot# Ew0150
On Thursday, August 21, 2008 I received the ZOSTAVAX vaccine to prevent shingles. On Sunday, August 24, I started having a headache, each day it was getting worse and no over the counter pain medication would relieve it. On Wednesday August 27, I couldn't stand the pain anymore and I went to the hospital where I was diagnosed as having Shingles. I can give you the report. I have also printed the form out for my doctor to complete for you. They put me on Valtrex 1GM three times a day. I took them for 2 days and then started to get really sick and vomit. I went to my doctor, on August 29 and he gave me something to calm my stomach so I could eat. From the hospital they sent me to my ophthalmologist because the shingles was on my face and all around my eye. They can also tell you about this if you need their input. They said I did have a spot on the cornea and to watch carefully if anything affected my vision. It didn't but my eye became swollen and sore. I have a photo that my wife took today if you should need it to see. This is not a small side effect, it is full blown shingles. 10/17/08-records received for DOS 8/27/08-presented to ED with C/O headache since 8/24/08-now teeth hurting. Two days prior noted rash on scalp and left temple. Impression:headache, rash most consistent with shingles.  DX: shingles. temporal arteritis. 1/27/2010 S/p CVA with residual dysarthmic.