chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 1 1/2 weeks after receiving immunizations, the patient had a seizure while riding in a car. He was taken to the ER and had another seizure. He stayed in the hospital about 4 or 5 days. Tests were done and he was put on medicine, which seemed to help lessen the seizures for a while, but would then become more frequent. Meds were changed and again seizures would lessen for a while, but then come back again. Meds were changed several times, with the same results. Around the 1st of January 2001, he was put on the ketogenic diet with almost instant cessation of seizures, except for small 'tics" which he continues to have. He is now on only one med (Zonegram). The mother gives history of the patient falling on the kitchen floor and hitting his head about two months prior to onset of seizures. She states she gave him Tylenol for the headache, but did not go to a physician at the time. She also states doctors are unsure if immunizations are connected to his seizures. doc 214099, annual follow up states the following:"05/13/2002, mother states that patient continues with diet and medications plus has had seizures since 04/2001. She states that physician did not want patient to  be on the diet for more than 2 years, which will be up in 11/2002. She states that the physician plan to try taking him off the diet at that time. She thinks the patient is a little too small for his age + gets a little more tired than before but lives a "pretty well normal" life + even plays T ball. Per follow up Pt has not recovered. 12/16/2002 father states pt had recent EKG whiched showed "slowness in brain". Is no longer having tics and is continuing on Zonegram 100mg. Still on ketoganic dish, but is to be weaned off innext 2-3 months and within 6 months hopes to be eating normally. Says he has gained some weight and is now in a gymnastic class. Seizure disorder now better controlled with Ketogenic diet taking Titralac, Bug Bunny Vitamins, Zonegran. Repeated ear infection, tubes placed @ 18 months of age. Dx made at ER: facial muscle twitching, decreased responsiveness. Early 11/2000 child slipped and fell hitting back of head(?) Had HA for 4-5 hours. No further HA reported. Hospitalized 2 days @ 8 months of age for high fever and dehydration. 3rd hospital admission 01/08/2001 - 01/11/2001 for ketogenic diet instition records were obtained
Eczema and Hives  over entire body.  Started with just an eye lid and some spots on mid-back, bra line.  Spots of eczema are literally random places all over my body now.   Either welts/hives, red splotches, and all extremely itchy.  I've never had eczema or rashes before.
Right arm with 1.75" by 2" area of erythema, no induration.
Headache; I have little liver issue nothing bad but just fatty; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; HEPATIC STEATOSIS (non-serious), outcome "unknown", described as "I have little liver issue nothing bad but just fatty". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got vaccinated on 10Mar2021 and after work, he started to have little of headache and his eyes everything would just gone away so. He had a test done on Wednesday and they told the patient that he/she has a little liver issue nothing bad but just fatty.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe outbreak of disseminated shingles/ affected other organs and other bodily systems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   Pt visited pharmacy to fill a prescription and pharmacist suggested that she should get zoster vaccine live (ZOSTAVAX) vaccination. On 28-APR-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on or before 01-JUN-2015, pt suffered a severe outbreak of disseminated shingles that eventually covered her body which forced her to be admitted to hospital. Due to the debilitating and severe shingles outbreak, which affected other organs and other bodily systems, pt died on 03-JUL-2015. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's injuries and death were caused by the zoster vaccine live (ZOSTAVAX) vaccine. Due to the shingles and resulting injuries, pt suffered excruciating physical pain and suffering, mental anguish and emotional distress, and loss of enjoyment of life prior to her death.  Upon internal review, the event of disseminated shingles was considered to be medically significant.; Reported Cause(s) of Death: severe outbreak of disseminated shingles/ debilitating and severe shingles outbreak which affected other organs and other bodily systems
Stomach hurts; Achy/ Sore; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurts) and PAIN (Achy/ Sore) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Cholesterol blood excessive.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN (Achy/ Sore). On 29-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurts). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurts) and PAIN (Achy/ Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetes medications, blood pressure medications and cholesterol medications.  No treatment has been given to the patient.
First Dose of Heplisav-B 4 Weeks Ago, 2nd Dose Engerix; Initial Report Received on 09-May-2023  A pharmacist reported that a 20-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.   Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 07-Apr-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941055; expiration date 29-Nov-2024, NDC # 43528-003-05) in the left arm.   On 08-May-2023, 32 days after having been vaccinated with HEPLISAV-B, the patient was given Engerix B (no details available) in the left arm as the second dose. No adverse reactions were reported by the patient.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Kinrix vaccine in L deltoid: Mild erythema, pruritus, inflammation surrounding injection sight.
Pt recv vax on 12/11/98; 3 min post vax pt exp paleness, limp, stiff arms & legs, eyes rolled back, tonic movements x 10 sec then unresponsive x 20 sec; tx=rested supine x 30 min
-Resident was admitted to facility on 4/14/2021 from hospital. Resident had been vaccinated prior to admission to facility on 3/10/21 and 3/29/21 which was given at another clinic/facility. Resident had history of (+) COVID-19 test results on 1/2021 and 4/9/2021 (Test done at facility). Facility is still doing a weekly routine COVID-19 Testing/Surveillance and on 4/21/20, resident was incidentally found to be still (+) COVID-19 (PCR Test). During that positive result (test date:4/21/21) the resident was asymptomatic at that time, and, Quarantine period completed 5/6/21. Resident expired on 5/19/2021
Pt came in 5/8/06 with rash which appeared on L thigh on 5/3/06. Dime-sized cluster of /// 4 blisters on a red base. Doesn't pick or scratch at it unless sees it. Varicella was given to L thigh 4/26. MD looked at it and said it has typical herpes virus appearance. Acyclovir /// cream; apply 5 x daily until reaction gone and to call us if it gets worse. We just saw pt on 5/8/06.
Diffuse pruritic rash with macules and papules covering bilateral upper extremities and chest.
COVID vaccine breakthrough case. Pfizer 3/8/21 EN6202, 3/29/21 ER2613 and boosted 12/20/21 ED7218
She reports that the injection site became swollen; warm to the touch; little lump; it looks like its forming a hickey on my arm; A rash in circles; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), MASS (little lump), CONTUSION (it looks like its forming a hickey on my arm), RASH (A rash in circles) and VACCINATION SITE ERYTHEMA (injection site red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), MASS (little lump), CONTUSION (it looks like its forming a hickey on my arm), RASH (A rash in circles) and VACCINATION SITE ERYTHEMA (injection site red). On an unknown date, the patient experienced VACCINATION SITE SWELLING (She reports that the injection site became swollen). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), MASS (little lump), CONTUSION (it looks like its forming a hickey on my arm), RASH (A rash in circles), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (She reports that the injection site became swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included warm or cold compress and Tylenol.
The patient started experiencing pain in his neck 7 days after vaccination and within 48 hours he lost all mobility.  He was taken to the emergency room and found to have a spontaneous  hemorrhage with cord compression in the cervical cord.  patient was hospitalized at the Clinic for 10 days and then transferred to rehab facility for week.  He had a syncopal episode while in rehab and was readmitted into the clinic.  He was stabilized and then later discharged in to another rehab for 5-6 weeks.  Patient is still ongoing with physical therapy and occupational therapy.  He was initially quadriplegic, but has regained mobility in his upper extremities and is progressing with mobility in his lower extremities.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       "Upon internal review on 04-Aug-21, the age units was corrected 66 years."
Swollen knees, fever, headache & red spots on the skin; Inject given @ 11AM rxn occurred 6PM;
1 hour after receipt of booster vaccine, developed pruritis and difficulty breathing, throat tightness; Stridor evident in the ED, hypotension requiring epinephrine injections and eventual infusion.
Sore arm for about 48 hours. 25 weeks pregnant with a due date of June 3, 2021. Have had in depth growth ultrasounds since then and baby is still measuring right on track now at almost 29 weeks.
arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Patient had second dose on 14MAY2021, lot number- 008C21A, expiration Date- 21DEC2069. The vaccine was administered on her upper right arm.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-132180 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
pt has had fever (amount unk), irritable, rash started 14MAR96 on legs, trunk, arms, & face;rash seems to be getting worse & spreading more; has vomited 2 or 3 times since vax;
Patient was feeling nervous about receiving vaccines .  When the first two vaccines on right arm were placed mom  said  that patient usually is very nervous  and causes her to syncope .when ever she receives vaccines or any blood draws.  Mom and I were watching and noticed she had  a stare and mom  rushed to try to talk  to her to keep her awake and I let mom come to her  so I can  get  Physician on duty .Patient was secure and siting  while vaccines were being placed and while mom attend her .  Patient was siting in back seat  and  was moved to front seat to lay her  and have her feet leveled. Patient never fell and was mained secured. Patients heart rate was 77 and oxygen levels were 99 %. Mom stated that patient only ate a cookie  all day. Once patient levels were good mom  was  telling patient she need to get her final vaccine patients mom authorized to go ahead and give the last vaccine  for the day . Patient was alert and fine when final vaccine was giving.
On Wednesday 01/20/21 approximately 8 days post vaccination a large area of my upper arm began to hurt and become hot , red, and swollen near the injection site. Today the pain and swelling are slightly better but it is still red and hot to the touch and has not shrunk in size any at all. Reminder, I had only the normal reactions of pain and a small knot
On 8/13 (2 days after injection), became short of breath with pleuritic chest pains and palpitations. Workup 8/17 showed bilateral PE with moderate clot burden and right heart strain. Admitted to hospital for initial treatment and monitoring cardiac status.  She is on no estrogens, does have small distal DVT in left leg (but I am not convinced that would lead to moderate burden of bilateral PE).  No family history of VTE
A non-serious spontaneous report of a large portion of the dose was expelled and received a second dose in each nostril was received from the mother of a patient concerning a 24-year-old female. On 30-Oct-2009 a large portion of the H1N1, Intranasal dose was expelled from the nostril during administration, the patient then received a second dose in each nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
The morning after I got the immunization, I awoke to s sore arm, it also felt warm to the touch. I took some Tylenol and my other daily meds. the pain eased up some, but came back when the medicine wore off. I thought the pain would gradually go away. It did not. 11-17-22,  I went to a regularly schedualed appointment with my Rheumatoligist. I told her about my arm and she wrote me a script for Diclofenac Sodium 1% Gel and suggested that I try it a couple times a day. It has eased the pain some, but it comes right back. 12-20-22, I returned to Dr for a schuedualed three month follow-up, I tood him about my arm still hurting and he ordered an X Ray of my right shoulder. I told him that it wasn't my shoulder that was hurting,  I had the X Ray of my shoulder done that day and recieved a card from Dr,  on 1-7-23. the card stated no acute shoulder injury and no Arthritis.  I had told him that the pain was around where the injection was given and not in my shoulder, so the X RAY results were not surprising to me. On 3-27-23 I went to see Dr. for a regularly schedualed three month follow up. The nurse, ( I don't know her last name) who gave me the flu vaccine last September, was in that day, it was the first time I had seen her since. She Looked at my are and said it looked fine to her  { mind you this was over six months after the vaccine was given to me }        i reminded her that I had had on a top with tight sleeves and how she had tugged and pulled on my shirt to get it up far enough to give me the shot. I told her it was like I had had a turniquet on my arm. at that, she didn't have anything else to say to me and when the Doctor came in he did his rutine exam and didn't want to discuss my arm he did say that maybe it would just go away.I am still experiencing pain and mobility issues in my arm. This has all been quite frusterating for me !!
Severe tingling and right hand right leg right side of abdomen and right side of face that lasted 48 hours. I went to ER they checked out with CT scan and I have MRI of brain and MRI off neck. All of the above are inconclusive and stroke was ruled out. I was started on a medication Astorostatin and vitamin B 12. Very mild symptoms of slight tingling on the face still persist but no other adverse symptoms
The site has been very swollen after the 1st dose; Soreness at the site of injection; Redness at the site of injection; Itchiness at the site of injection; Diarrhea; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE SWELLING (The site has been very swollen after the 1st dose). At the time of the report, VACCINATION SITE PAIN (Soreness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: significant follow up appended
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of flushing of arm in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included asthma. Concurrent medical conditions included environmental allergy. Concurrent medications included ZYRTEC, PRILOSEC and NASONEX. On 16 October 2013 the subject received 1st dose of FLUARIX (.5 unknown, unknown route, right arm). On 16 October 2013, within minutes of vaccination with FLUARIX, the subject experienced flushing of arm (described as flushing of the arm, face and neck"). On 17 October 2013, 1 day after vaccination with FLUARIX, the season experienced fever, chills and fatigue. At the time of reporting the outcome of the event of flushing of arm (described as "flushing events) had resolved. The outcome of fever, chills and fatigue were was unknown at the time of reporting. The healthcare professional considered the event were probably related to vaccination with FLUARIX. Follow up was received from nurse practitioner on 12 November 2013. The nurse practitioner documented that all events were resolved on 19 October 2013. The nurse practitioner identified the suspect product as FLUARIX. The nurse practitioner did not consider this case is serious. The nurse practitioner documented that the case did not involve a congenital anomaly or birth defect. The nurse practitioner documented that the subject had "receive flu shots in the past without any problems." The nurse practitioner also reported that the subject had not experienced any adverse events following previous vaccinations.
Information has been received from a physician's assistant concerning a 34 year old Hispanic male with a penicillin allergy who on 04/02/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (0.5 cc) (lot # 636399/1179K), subcutaneously.  There were no concomitant medications.  The patient denied HIV, asthma, HTN, OM, steriod or drug use.  It was noted that the patient "works with various cleaning chemicals."  It was also reported that the patient was "susceptiple to rubella."  On 04/12/2002 the patient developed an erythematous maculopapular rash (on face, head, torso, arms, chest, and back), and a sore throat, and joint pain.  On 04/15/2002 the patient presented to the doctor's office with rubella.  The rash was described as non-pruritic, and there was no discharge from lesions.  It was reported that there was rythema of posterior pharnyx, and positive tonsillar posterior cervical lymphadenopathy.  The patient sought unspecified medical attention.  The patient was eventually cleared by physician with "rubella IgG positive, IgM negative" on 04/20/2002.  It was reported that the patient recovered on 04/23/2002.  No further information is expected.
Client was scheduled to receive Bivalent Moderna booster shot, but was mistakenly given Moderna for 6m-5y (patient)
Information has been received from an RN concerning a 9 year old white female with no medical history who on 3/8/99, was vaccinated in the left arm SQ with the first dose of varicella virus vaccine live (lot # 626405/1840H). There was no concomitant therapy. There was no illness at the time of vaccination. The RN reported that on 3/10/03, the patient had an outbreak of chicken pox. There was no laboratory test performed. At the time of this report, the outcome was unknown. It was also reported that four other patient's in the same school also developed chicken pox after being vaccinated with varicella virus vaccine live. Additional information has been requested.