chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 56-year-old female patient who received dTpa vaccine. The patient's past medical history included pituitary adenoma (asymptomatic pituitary adenoma). On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 21 days after receiving dTpa vaccine, the patient experienced acute disseminated encephalomyelitis (serious criteria GSK medically significant), myelopathy (serious criteria GSK medically significant), brain stem dysfunction (serious criteria GSK medically significant), cerebellar disorder, pleocytosis and white matter hyperintensities. On an unknown date, the outcome of the acute disseminated encephalomyelitis, myelopathy, brain stem dysfunction, cerebellar disorder, pleocytosis and white matter hyperintensities were unknown. The reporter considered the acute disseminated encephalomyelitis, myelopathy, brain stem dysfunction, cerebellar disorder, pleocytosis and white matter hyperintensities to be possibly related to dTpa vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 56-year-old female patient who was vaccinated with unspecified Tdap vaccine (manufacturer unknown). The patient had a history of asymptomatic pituitary adenoma. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received unspecified Tdap vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between July and October 2016, 3 weeks after vaccination, the patient presented with subacute progressive multifocal neurological symptoms including myelopathic, brainstem, and cerebellar deficits. Repeated magnetic resonance imaging (MRIs) demonstrated multifocal and progressive T2/FLAIR hyperintensities of the cauda equina, long spinal cord segments, supratentorial and infratentorial brain white matter, with scattered associated contrast enhancement. Cerebrospinal fluid, clear (CSF) was notable for lymphocytic pleocytosis with 128 White blood cells (WBCs) (normal range not provided) and elevated protein (value and normal range not provided). Extensive infectious, neoplastic/paraneoplastic, and autoimmune workup was unrevealing. Subsequently, the clinical diagnosis of acute disseminated encephalomyelitis thought to be secondary to Tdap vaccination was made. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of acute disseminated encephalomyelitis possibly associated to unspecified Tdap vaccine. The author concluded, "This two patient case series provides further evidence for a possible association between Tdap vaccination and acute demyelinating events." This is 1 of 2 valid cases in the same literature article.
Sometime following the vaccination, the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Information has been received from a physician concerning a 72 years old female patient with no drugs reactions or allergies who in approximately 2004 "5-6 years ago", was vaccinated subcutaneously with her first dose of PNEUMOVAX 23 (lot number unknown). Concomitant therapy included LIPITOR. The physician stated that on 19-OCT-2010 "after the patient was vaccinated subcutaneously with her second dose of PNEUMOVAX 23 (lot number 665402/1339Y; expiration date: 22-MAY-2011)", she complained her arm was red and painful. The patient also developed rash on her arm where injection was given. There were no laboratory tests performed. At the time of this report, the patient was recovering. The patient sought medical attention by a telephone call. This is one of several reports from the same source. Additional information has been requested.
MODERATE LOCAL REDNESS AND AREA SWELLING OF  LEFT DELTOID REGION. DIAMETER OF ERYTHEMA: 5 INCHES ACROSS DELTOID BUT NOT REACHING ELBOW.
8/23/10 4pm-5am rash from head to toe & constant crying-> Mother reported 8/24/10 at 1pm & child in daycare with very faint rash, cheerful no crying noted. T-102.6-Rectal at the time.
During conversation after the vaccine, patient stated he felt weird and dizzy.  He was instructed by MA to lay down, as he was moving from sitting position to laying  on the exam table, he experienced syncope.  Syncope lasted  about a  minute, he woke on his own  confused and sweating.  The physician was alerted to assess, juice and pretzels given, patient was able to sit up and applied ice pack to back of neck.  Patient wanted to get up and walk to bathroom to urinate.  He began to walk to bathroom and told MA he was feeling weird again and she observed his lips turning white.  He was escorted to exam room to lay down on back with knees bent. BP 100/66 after syncope.  Physician attended patient, he was awake, talking , pale and sweating.  BP low but mom stated to physician his BP is always low or in that range. Remaining exam was normal.  Had patient rest until felt able to stand and walk out of office without help and advised to rest and not do strenuous activity at home after visit.
Patient  received vaccination and was sitting in pharmacy for the 15 minutes to be monitored.  After sitting in chair for 5 minutes patient became faint and fell out of chair and hit side of head on ground.   Patient sustained cut to his right eye as well as swelling.  Patient was given Ice pack to control swelling and stayed in pharmacy for an additional 20 minutes where he was closely monitored.  Patient did make decision to get up and leave and was able to walk out on his own.
About an hour after receiving the 2nd vaccine, she developed a pain in the upper-mid sternal area.  She's not had any pain like this in the past.  The pain remained constant ever since it started, and there don't appear to be any alleviating factors such as position changes.  Deep inspiration makes it worse.  The pain radiates at times across the upper chest and down the back.  She's had some accompanying nausea.  She's also noticed feeling a little short of breath as the day progressed, which is not necessarily related to the pain.  She denies any palpitations or dizziness.  No near syncope or syncope.  The pain remained  a maximum intensity of 10/10. She therefore presented to the ER. Diagnostic studies including labs, EKG and a CT pulmonary angiogram were performed.  Troponin returned as elevated, but without EKG changes. She was transferred at the time to the Medical Center for admission. Echocardiogram was completed and normal. Vital signs remained normal. Troponin trended down. Pain improved and she was discharged home.
Developed lip tingling - hour list vaccine followed about an hour later by urticaria on lower back  Resolved after about 1 hour given Zyrtec 10 mg
Pt recvd DTP/OPV/HIB & began screaming & cont screaming for 40-45mins; color was good, heart rate was very rapid, breathing adequate but jerking similar to exaggerated startle reflex; pt was like a limp doll & soaked w/perspiration;
1st dose 07Jan2020, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 7th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The patient never received the second dose. At the time of reporting, the reporter did not have the lot number/ expiration date information of the first dose available.  The reporter gave permission for follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The details were reported for the first dose.
VACCINE EXPOSED TO TEMP OUTSIDE OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
pt recv vax 30OCT95 & devel swelling of the arm extending from the elbow to the wrist;tx w/DPH;sx resolved in 3 days;pt had not recv vax in the past, but recovered from a case of pneumonia one month ago;
This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a child subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced possible allergic reaction. The healthcare professional inquired about information on allergy testing for neomycin and later stated that a child subject had a possible allergic reaction to HAVRIX. The reporter did not want to provide additional information or contact information stating this had already been reported. A search in the GSK database did not locate the possible allergic reaction with HAVRIX, therefore case A1014504A was databased. At the time of reporting the outcome of the event was unspecified.
Information has been received from a physician concerning a 26 year old female with an allergy to DEMEROL who was vaccinated in December 2007 with her first dose of Gardasil (lot# not reported). The patient had severe headaches after receiving this vaccine. In February 2008 the patient was vaccinated with her second dose of Gardasil (lot# not reported). Subsequently the patient experienced neurological symptoms within the first couple of weeks after receiving the vaccine. The patient was referred to a neurologist and she had either a cat scan or MRI. The test was positive for inflammation. The patient's outcome was not reported. Follow-up information was received from a physician. The patient had no pertinent medical history or no family history of adverse reactions in siblings. There was no illness at the time of vaccination. The patient was vaccinated with her first dose of Gardasil on approximately 30-OCT-2007. On 30-OCT-2007 the patient developed severe headaches "right after the vaccination". On 14-JAN-2008 the patient was vaccinated with a second dose of Gardasil (lot# 659653/1448U) in the deltoid. There was no concomitant medications at the time of the vaccine. On 08-MAR-2008 the patient developed progressive dysesthesias and numbness of limbs and trunk, clumsiness of hands and gait and was hospitalized. On an unspecified date magnetic resonance imaging of c-spine showed an inflammatory lesion and MRI of the brain revealed one other inflammed spot. A lumbar puncture was abnormal. The physician reported that this is all consistent with an acute central nervous system inflammatory condition which occurred about 2 to 3 weeks after the second Gardasil. At the time of reporting the patient had not recovered from the CNS inflammation. The reporter felt that central nervous system inflammation was disabling. Additional information is not expected. 4/28/08-records received for DOS 3/9-3/15/08- DC DX: Transverse myelitis. Admitted with paresthesia in limbs. Symptoms gradually getting worse and moved over to trunk.
This spontaneous report as received from a registered nurse refers to 2 unspecified teenage boys each received an expired dose of GARDASIL (lot # 669308/0636AA, expiry date 11-AUG-2013, route and dose were unknown) as their first dose in the series on 12-AUG-2013. No adverse effect reported. Additional information has been requested.
The companies 3mL syringe (25G - 1") syringe being used for administration (Lot#9001856 - exp. 12/31/2023) allowed the vaccine contents to leak out/squirt out of the connection area between the needle and syringe. The patient did not receive the full dose of COVID vaccine.
difficulty swallowing; swelling left side of throat; can't turn head to the left; overall body itching rash especially on neck, check and torso, which turned into large bruises
second dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: second dose has not been administered yet). The outcome of the incomplete course of vaccination 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 Information: GSK receipt date: 15-Aug-2023 The pharmacist called to inquired that how to proceed with Twinrix rapid dosing schedule. The patient was on the accelerated schedule and was at 11 days for a second dose. The reporter mentioned that this patient was leaving out of the country and wanted guidance of series schedule. The reporter declined to provide any patient details. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
moderna Dose Number 6; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Lot number: HF9275), in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Lot No: 057f22a), administration date: 09May2023, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Lot No: a57145c), administration date: 15Sep2022, for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (10Oct2023) and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2023, outcome "recovered", described as "moderna Dose Number 6". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2023) Negative, notes: Tested negative day 6 and day 8; (12Oct2023) Negative, notes: Tested negative day 6 and day 8; (14Oct2023) Positive, notes: Day 10 started with fever, runny nose, cough and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. COVID 19 Treatment includes Paxlovid from 05Oct2023 to 09Oct2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
feeling sick; weak; sore; achy all over; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), ASTHENIA (weak), PAIN (sore), MYALGIA (achy all over) and NAUSEA (nauseated) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced MALAISE (feeling sick), ASTHENIA (weak), PAIN (sore), MYALGIA (achy all over) and NAUSEA (nauseated). At the time of the report, MALAISE (feeling sick), ASTHENIA (weak), PAIN (sore), MYALGIA (achy all over) and NAUSEA (nauseated) outcome was unknown.            No concomitant medication were reported. No treatment information was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Moderna COVID Vaccine D#1 (1/7/21) and D#2 (2/4/21) -- > tested COVID (+) 5/27/21 and hospitalized
Vaccine received ~12:30pm. Onset of rash on hands and arms upon waking up on 10/21. Rash also appeared on legs and in spots on back. Rash is red, raised, itchy bumps. Treating with topical hydrocortisone and oral antihistamines.
Received covid #1 end of Dec 2020. Received Covid #2 January 2021.  Heavy periods started Feb 2021. Found out I have iron deficiency anemia in April. Heavy periods continued. Now I am having to get iron infusions and a hysterectomy.
Patient asthmatic. Had breathing problems and felt like a knot in chest. Still having breathing problems feels like tennis ball in throat, went to doctor next day. Used inhaler and was given BENADRYL and Vitamin B6.
10 days post imms patient started with rash on his trunk that is now front and back of trunk and neck. No fever, nausea or vomiting. Patient is eating and drinking fluids. Mom stated behavior is normal. Family also just returned from a trip. Went to beach.
Fever started within 48 hours. 5:30 pm March baby acting lethargic and went into seizure which lasted approx 6 minutes. 911 called and responded. Rescue breathing and oxygen given. Rushed to hospital. HIgh dose of Motrin given to reduce fever.  They noticed ear infection which was not present at well visit two days prior when he recieved the shot.  Baby was unresponsive for approx two hours.  Starting coming around when fever broke.  Was administered antibotic for ear infection.
This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 17:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included wheat allergy, corn allergy, chocolate allergy and tomatoes allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269) via an unspecified route of administration in the left arm on 23Feb2021 at 18:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 25Feb2021 at 05:00, the patient experienced severe headache, body aches, chills and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache, body aches, chills and sore throat were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Day after vaccination Pt. experienced redness and swelling at site of injection, the following day the redness extended to her right elbow with swelling which spread below her elbow.  She also began to experience epigastric pain three to four hours after vaccination.
No adverse events other than needing a repeat adult hepatitis A vaccination. Pediatric dose given.
This RN received a phone call from the wife of the client whom is reported in the VAERS. She reports that her husband received a 2nd shot on 2/25/2021 and on 3/20/2021 was in so much pain in his leg that she took him to the Emergency Room. Reports he then received an ultrasound where it was found that  he had a blood clot in his upper leg (near groin). She has heard about the issues with COVID vaccine and blood clots and wanted to make sure that this was reported. He is following with his PCP and Vein specialist. Reports he received the shot from Pharmacy. She said she will probably do a VAERS report also. Reports is doing much better now, but thought they should have it reported.
Pt reports continued fatigue and muscle aches sine day after vaccine given. Currently being followed by PCP Numerous scans, and blood work for work up by PCP
Body aches Fever 99.3 Headache  Pain at injection site right more than left
Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely tired) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-J202A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely tired). At the time of the report, FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Elevated BP with migraine headache. BP 160/104, HR 106.  Reported- visited doctor and BP returned to normal.
Patient had already received a high-dose flu shot on 09/26/23 and received a second high-dose flu shot on 10/20/23.
Presented to ED with shortness of breath, hypoxia, cough, 72% spo2, hypotensive,  Started on decadron, singulair, aspirin, remdesivir, zinc, vitamin D, melatonin, albuterol, pulmicort. Developed sepsis and was given antibiotics Placed in comfort care and passed away.
Information has been received from a physician referring to a 16 years old male patient. The patient's medical history and drug reactions/allergies were unknown. On 13-OCT-2016 (reported as "today"), the patient received a dose of GARDASIL (lot#, expiration date, dose and route were unknown) and a dose of VAQTA (lot#, expiration date, dose and route were unknown). After the administration, the patient passed out which happened so quickly. Unspecified treatment was given for the event and the patient came around good. It was unknown if the lab diagnosis was performed. The causality assessment was not reported. Upon internal review, passed out was determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness (light headed) for 15 minutes after injection.  BP was 115/78 and shot up to 129/84. Painful muscle swelling and stiffening around the injection site and the entire outer upper left arm that started at around 9:30pm.
pt recv vax 7FEB96 & lt side hip & leg pain w/synovitis showing;pt was taken to ER & aspirated which showed a scant amount of fluid which eventually grew staph;
Pt notified RN that she vomited following influenza vaccine, but still wants to get the Pfizer vaccine. Following administration, pt felt nauseated and EMS notified.  Blood sugar 121. Pt monitored by medical provider and EMS for 45 minutes. During that time, pt vomited once. No meds given. Pt stated she felt better and left with family in good condition.