chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache about an hour after; chills and worsening headache around 6 PM into the night; took Tylenol around 7 PM for the headache, and it improved; chills and returning headache kept me up during the night and I probably had a fever as well; took temperature at 9:30 AM the following morning and had a fever of 100.3 F; napped until around 3 PM and felt better when I woke up (headache, chills, fever gone)
During normal morning grooming routine my right arm suddenly became numb accompanied by whole-body weakness and tremor, tachycardia, and elevated blood pressure.  My husband drove me the the ER during which time I developed a right-side headache (different from left-side migraine I usually experience). During 8 hours in the ER I was given meds and tests (described in #19), then admitted for two more days of tests, meds, and observation.  Nothing abnormal was found. I was released with blood pressure Rx's and follow up appointments. I have not regained my previous energy and strength and continue to require blood pressure meds and experience muscle weakness.
Runny nose, fever, headache, loss of appetite, lethargic, couldn't sleep, dizzy.  Today she feels congested.
Patient hands felt tingly, head felt tingly, got light headedness. patient was put into a wheelchair and taken to observation room by nurse. Patient was alert and oriented. Patient feels better after drinking some water.
Moderate erythema of skin surrounding injection site. Patient c/o itching without pain in same area. Started about 24 hrs after injection given.
Woke up at midnight with severe body aches, headache, stomach ache, diarhea,
Middle and outer ear infection in left ear from about 1/2/22 until 1/11/22.  Bell's Palsy facial paralysis on left side from 1/11/22 until present (1/14/22)
Well I developed a 104 fever approximately 9 hours after the second dose of the vaccine. I became sweaty, vomiting and had muscle spasms all over my legs and arms. I have never experienced anything like that before so it was very strange. I noticed that I was swelling and having problems with high BP. They have not been able to get that under control since then, rapid heart beat as well and nosebleeds too. Blood would be pouring out of my nose. I contacted my DR after, I don't remember the date of my initial contact with them. I most recently saw the DR on June 11th 2021 as well.
Blood pressure is fluctuating; Has not been feeling herself; Dizziness; She has no energy and spends a lot of time in bed/weakness; Tiredness; Body ache; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension. Concomitant products included LOSARTAN and LEVOTHYROXINE for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness), FATIGUE (Tiredness), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at a dose of 81 mg. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness), FATIGUE (Tiredness), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.            This case was linked to MOD-2021-228265 (Patient Link).
This spontaneous report was received from Nurse, referring to 4 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications wee not reported. In 2017, between 18-JAN-2017 and 07-FEB-2017, the patients were vaccinated with an improperly stored dose of VARIVAX with lot # M009764 and expiration date on 23-FEB-2018 (anatomical route of vaccination was not provided) for prophylaxis. The Nurse stated that, VARIVAX, was exposed to a temperature of  > -10°C but < 8°C, > -15°C but < -l0°C, for a time frame of 13 days, 80 hours. Data logger was not involved. Furthermore, it was reported that VARIVAX, was never expose to a temperature excursion before and that no product quality issue was involved. Additionally, no adverse events were suffered. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007841: US-009507513-1702USA007842: US-009507513-1702USA007843:
Approximately 30  days after vaccine, left arm itchy and hives. By January, 12inch rash on arm that oozes in elbow crease and crusty.
The patient was given her flu immunization in a group flu line at approximately 1:15 pm.  The patient was screened using the 2010-2011 military seasonal flu questionnaire and all questions were reviewed with the patient by the screener.   Patient returned to Immunizations at 1:25 pm with the complaint of generalized itching, flushing, and slight vertigo with "anxious" feeling. Pt was assessed and anaphylaxis protocol was initiated.  VS T 99.4F, B/P  127/79,  AP 78 reg., RP full, Resp. deep equal and clear to auscultation bilaterally, SAO2- 97%.  Pt color pink-skin warm moist. Pt. was alert and oriented X 3.  Erythematous non raised rash noted on face and anterior chest.  Pt denied any nausea, dysphagia, or dyspnea.   1:30 pm physician evaluated patient and Zyrtec 10 mgm  by mouth was given.  The patient was evaluated every 5 min. X 6, then every 10 min X 3, then every 15 min  x 5. At 2:00 pm  Solu Medrol 125 mg  was given IM in the LUOQ per MD order.  At 2:30 Benadryl 50 mgm was given IM in the UORQ per MD order.  The rash, itching, flushing and anxious feeling abated at 2:40 pm.  No dysphagia, dyspnea, nausea or uticaria was ever noted.  Patient took clear liquids without difficulty and retained.  Pt. ambulated with a steady normal gait.  Pt. voided qs without difficulty.  At 3:45 the patient was discharged home via wheelchair accompanied by coworker.  Discharge instructions and prescription for Benadryl 50 mg po q 6 hours x 48 hours were reviewed in detail with patient who verbalized understanding of all instructions and prescription.
02/03/2022 I started having dizziness, My BP was 75/56 and my oxygen was 43. I struggle and my husband called the ambulance. I was given an IV. I was told to follow up with my Physician. It was almost like  a machine that it was unplugged and the power went out, that was me. That is exactly how I felt, They diagnosed me with bradycardia and first degree AV block. I got to go back in a few months to get lab work done.
About three days after injection, it felt like a cut had opened at the injection site and then a thin vertical scab about 0.5 inches long formed at the injection site. The scab is still there 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 27Apr2021 at 10:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021, about three days after injection, the patient felt like a cut had opened at the injection site and then a thin vertical scab about 0.5 inches long formed at the injection site. The scab was still there 2 weeks later. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt like a cut had opened at the injection site and then a thin vertical scab about 0.5 inches long formed at the injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling about 21 X 22 cm around the shot area, redness slowly disappearing, but still swollen.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: 6th day came out negative COVID test; (Nov2022) Positive, notes: came positive after 3 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient had previously received a COVID-19 Vaccine. Patient received Paxlovid as antiviral treatment form 16Nov2022 to 21Nov2022. Rebound on symptom of COVID-19. Patient took 5 days and 6th day came out negative COVID test and came positive after 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt faint, dizzy, blood pressure decreased......Paramedics checked him and he eventually left under own power.
Left thigh was swollen, red and warm to touch. Had no other symptoms. Child's mother states when he woke up the morning of 2/1/01, his left thigh was red and swollen. Referred to MD and they instructed mother to put an ice pack to his thigh. I did a follow-up call on 2/5/01 and mother states child's symptoms went away on 2/3/01 and he is fine.
headache fatigue Difficulty thinking cold chills causing shivering and chattering teeth Feeling of arthritic joints Sweating
Patient was given the booster dose for 12+ years of age as opposed to the orange cap booster for 5-11 year olds. Patient not having any adverse reaction.
Fever was noted and throughout the night progressed to reach 102.9. Was given infant Tylenol and did not improve so gave infant Motrin per Dr. office. Helped slightly but fever remained until 12/25/2014. Lowest fever ever got was 99 degrees. Two days into the reaction patient developed spotty rash. Patient was also very fussy and agitated.
Headaches almost everyday Injection site swelled, hot to touch injection site had welt on it injection site was red lymph node was swollen, felt like a knot in her arm pit
Substantial back pain after 3-4 drinks, as well as a medium grade fever (102). Patients should be warned of this.
Scaly painful rash forming around lips, has grown up both of my cheeks and around my left eye. It has also formed on my neck knuckles  and hands. Its bumpy like braille individual bumps with space between the next bump. On my face it burns, and is dryer. I am itchy eveywhere to the point that I cannot sleep. I have taken an allergy pill today to try and get relief but I must admit this isn't pleasant.
This spontaneous report has been received from a medical assistant, and refers to a 4 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 31-JAN-2018, the patient received an improperly stored dose of VARIVAX lot # reported as N019838 (dose, route of administration and expiration date were not reported) and M-M-R II for prophylaxis. The temperature range was from 6 degrees Fahrenheit (°F) to -14 °F for a time frame of 6 hours , with no previous temperature excursion. The temperature excursion was called because a data logger. There was not adverse effect or product quality complaint involved. Lot Number N019838 is NOT valid for VARIVAX.
This spontaneous report as received from an unspecified reporter as part of a marketing research program refers to a 54 year old patient. On 06-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and lot # not reported) intramuscularly. On 06-NOV-2015, the patient experienced burning sensation at injection site. On the same date, the patient recovered. This is one of several reports received from the same reporter. Additional information is not expected as there is no contact information.
Admitted with complaints severe headache x 10 days, chills and cough , a few hours after admission patient complained of severe RLE pain
Began symptoms of covid 1/12/2021. Tested positive 1/14/2021
Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, -09248 and 2011-09249. A nine-month-old male infant had received a DTP vaccine at six months of age (manufacturer unknown, lot number, route, site and date of administration not reported) and at 9 months of age, developmental delay was noted, along with seizures, complex neurologic dysfunction and eventually microcephaly. The patient died when they were nine years three months of age. At that time, brain lesions were those of classical perinatal hypoxic-ischemic injury, consisting of periventricular leukomalacia and "status marmoratus"; there was associated atrophy. Documents held by sender: None.
Patient received the MMR vaccine as part of 3 year old well exam. After leaving the office, he developed severe coughing episode and difficulty breathing in the parking lot. They returned to office where he was found to be wheezing, had decreased air movement and oxygen saturation of 92%. He received Benadryl, Orapred steroid and nebulized Xopenex 2 times. After treatment he was normal and remained symptom free overnight. There were no other foods or medications ingested during that time.  Nurse follow up on 10/11/04 states: "Anaphylaxis, Allergic reaction to gellatin."
TEMP OF 101; AGRESSIVE CHILLS; ARM SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAR-2021, the subject experienced temp of 101. On MAR-2021, the subject experienced aggressive chills. On MAR-2021, the subject experienced arm sore. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp of 101, aggressive chills and arm sore was not reported. This report was non-serious. This case, from the same reporter is linked to 20210331319, 20210331262, 20210331104, 20210332072 and 20210331202.
CLIENT RECEIVED PEDIATRIC FORMULATION OF HEPATITIS B VACCINE INSTEAD OF ADULT.  ERROR NOTED ON QA AUDIT ON 8/22/12.  ADULT FORMULATION OF VACCINE ADMINSITERED ON 8/22/12 WITH EXPLANATION TO CLIENT.
Sudden onset of tachycardia up to 166 BPM, nausea, pre-syncope, facial flushing, diarrhea, shakiness/tremors. Blood pressure was 101/63. EMS came to assess me and they were going to take me to the hospital, but I refused. Hours later at 7:30 PM I'm feeling better, but still nauseous.
Chills, body aches, fatigue, sore left arm (expected), soreness in left armpit.
Initial unsolicited report received from physician via Pfizer (manufacturer report number: 2017050313) on 22 Feb 2017. This case involves two-month-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP vaccine) (Batch number, expiration date, dose, route and site of administration was not reported) on 06 Jan 2017. The patient's medical history and concomitant medications was not reported. On 07 Jan 2017, one day following the vaccination, the patient experienced bad rash and diarrhea and went to emergency room. On 08 Jan 2017, patient was back in the ER as rash had progressed. Lab data was not reported. The patient received corrective treatment with topical steroids. On 09 Jan 2017, the patient was recovering from the event (reported as "he was better"). List of documents held by sender: none.
broke out w/multiple areas on trunk;areas scabbed w/in 24hr;mom describes as mild no temp sites itchy using DPH;
Patient reported to imms on 7/25 with complaints of redness and swelling to left arm following PCV 13 vaccination. Patient's arm examined. Patient had a redden area on the deltoid area approximately the size of patients palm and slightly raised. Patient denied any pain at the time of visit but did indicate pain the day of vaccination. Full range of motion demonstrated. Declined fevers. Instructed patient to put ice and monitor for s/s of infection.
Hives on hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "celiacs dx" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Gluten, reaction(s): "Allergy". The following information was reported: URTICARIA (non-serious) with onset 22Nov2021, outcome "recovered" (26Nov2021), described as "Hives on hands and feet". Therapeutic measures were taken as a result of urticaria. Additional information: Treatment included hydrocortisone ointment and Benadryl PO. The patient did not receive any other vaccine in four weeks. Covid prior vaccination and covid tested post vaccination was reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M033583 with expiration date of 14-APR-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014483: US-009507513-1703USA014484: US-009507513-1703USA014485: US-009507513-1703USA014486:
Tingling feeling in neck and scalp as well as a cool feeling in arm that vaccine was administered about 20 minutes after administered. Fatigue and skin sensitivity the following 2 days. Then pins and needles sensation in both arms, scalp, neck, face and lips intermittently for the course of 3 1/2 weeks. On 10/27/16  cool/ burning sensation developed in both arms, neck, mid back and scalp along with feelings of dizziness and fatigue. Pins and needle sensation still present intermittently. Visited the physician assistant who wanted to schedule an MRI. Ended up feeling worse by 10/31/16 with feelings of generalized weakness an leg weakness. Went to ER for full work up. All tests came back normal. Now to follow up with a neurologist.
was nursing at that time/child experienced side effects after the Pfizer dose also; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-016614 (Moderna).  A 3-year-old female patient (not pregnant) was exposed to BNT162b2 (BNT162B2), transmammary, administration details for the mother: on 27May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The mother's relevant medical history was not reported. The patient's and the mother's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose: 2 (booster), Caller stated first booster dose (Moderna)), administration date: 16Dec2021, when the patient was 2-year-old, for Covid-19 immunization; Covid-19 vaccine (Dose: 1, Caller stated first COVID-19 vaccination received was J&J), for Covid-19 immunization. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "was nursing at that time/child experienced side effects after the Pfizer dose also".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200008197 Mother Case;