chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 31-MAY-2011, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 0552Z, (expiry date: unknown) No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested
Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on left arm on 02Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included fibromyalgia. The patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced low grade fever, tingling face and tongue, muscle aches, and fatigue, all on 03Jan2021 06:00. The events were reported as non-serious. Patient was not diagnosed with COVID-19 and has not been tested for COVID-19 prior to vaccination. Outcome of the events was recovering.  Information on the Lot/Batch Number has been requested.
Pediarix and Hib #1 given 8/4/04. On 8/5/04 around 36 hours later. Pt vomited x 2 and became very lethargic.  Sleep 12 hours/ time. No fever. No rash. No dehydration clinically.   Nurse follow up on 08/30/04 states: "sepsis vs vaccine; encephalopathy." Medical records are received for the 2-day admission from 8/6-8/8/04 for this event. The diagnosis at discharge was R/O sepsis vs. vaccine encephalopathy. All cultures; blood, CSF, urine were negative as was rotavirus, parainfluenza and adenovirus. Highest temp in the hospital was 99 F ax.
This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The nurse reported that the patient was vaccinated with the 1st dose of GARDASIL (lot # not reported) 0.5 ml, intramuscular on 19-NOV-2012, the 2nd dose was administered on 13-DEC-2012 and the 3rd dose was administered on 31-JAN-2013. No adverse effects reported. Additional information is not expected.
sore arm; tired; It made my thyroid level go crazy for a couple of weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart attack" (unspecified if ongoing), notes: I had a heart attack at 31. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "tired"; THYROID FUNCTION TEST ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "It made my thyroid level go crazy for a couple of weeks". The events "sore arm", "tired" and "it made my thyroid level go crazy for a couple of weeks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a sore arm and was a little tired for a few days. The patient had bloodwork done between the 2 shots. It made thyroid level go crazy for a couple of weeks (irregular thyroid level) and then it went back to normal. No effect on heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe
Information has been received from a registered nurse concerning a "11 or 12 years old" female patient who "about a year ago" (in approximately 2010), was vaccinated with a dose of GARDASIL 0.5 ml, intramuscularly (expiration date and lot number not reported). "About a year ago" (in approximately 2010), the patient experienced a sterile abscess after she received GARDASIL. The patient was hospitalized "duration and location were unspecified". The patient received "unspecified" treatment for the event. Therapy with GARDASIL was discontinued. Therapy was not reintroduced. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
7hrs after vaccinations, was woken up from nap to eat. Took bottle normally then vomited large amount. Gagged while vomiting, then started having difficulty breathing. Grunting with breathing. 102.6 degrees. Unable to cry or suck. Went to Emergency Room, admitted.
Pt recvd 1 dose of Engerix-B & 2 1/2-3 wks p/4JUN92 dose had rash on both legs that does not itch & looks like petechia;
MY MOM DEVELOPED SHINGLES 10 DAYS AFTER THE VACCINE-   NOT SURE IF THIS IS RELATED TO THE VACCINE   --
10/11/11 HPV #3. 10/18/11 Fever, headache, neck stiffness c/w viral meningitis --> full resolution of symptoms.
I woke up at midnight after a half hour of laying down I woke up disoriented spatially, took a step and collapsed husband got me bathroom, could not remain on toilet, 911 was contacted transported to ER stayed for 8 hours. Discharged in wheelchair determined not having stroke, diagnosed as neuro vestibular disorder, non-ambulatory.
Light headed, tired, chills, 102 fever that lasted approximately 8 hours and my head hurt felt like it was going to explode. By the next morning I was feeling much better but weak and tired.
heart fluttering, pressure in left ear, shocks in chest, similar to food allergy reaction
Resident began have large amounts of loose stools on 1/13/2021 and continued through 1/14/2021.
Patient was given influenza immunization at the facility in the afternoon at a workplace imz event. As the needle was withdrawn, his barrier bandage filled with blood and was contained and a second regular type bandage was placed on top of it to secure the bandage in place. Patient got up and walked to his dad and sister and left the facility. They returned approximately 5 min later because the bandage was leaking blood. As he came toward the pharmacist so we could clean the spot of injection he fainted and one of the pharmacist caught him. He blacked out for about 30 seconds and came to and was clammy, cold and sweating. Security was on site and called EMS that was on duty came to the area within a few minutes and assessed the scene. They took vitals and the father declined an ambulance. Patient was given water and vitals checked out to be normal and father took him home.
Shortly after receiving vaccine pt began to notice pain in her deltoid region which radiated up into her trapezius muscle and also down her arm slightly.
Headache, tired, high pulse rate of 110. Fever, dizziness, sweats.  Blood pressure slightly elevated.
11:55 - Had throat itching and chest itching.  Vitals checked and stable.  25 mg PO Benadryl given x 1 with water.  All symptoms improved and she was symptom free after 10 minutes.  Monitored for a total of 45 minutes and released on own care.
On 10/17/00, pt presented to physician with red papules which started on abdomen, some with blistering but no crusting. Rash itches. Papules also seen on arms and legs.
Subject had initial fatigue on the day after (Sep 11), but the major event was fainting on Sep 12 (2 days after), combined with disorientation upon hitting her head from fainting. Fainting was sudden, unexplained and unexpected.
Severe whole body myalgia beginning 24 hrs after admin. of vaccine. Symptoms continued 5 days later, and required missing 2 1/2 work days.
Information has been received from a consumer concerning a child who was vaccinated with a dose of Varicella. The reporter indicated that her child attended a school where another child in the first or second grade was reported to have developed a case of break through chickenpox on approximately 21-APR-2006. It was unknown if medical attention was sought. Additional information has been requested.
A few minutes after receiving the shots I broke out into a sweat, the back of my neck was hurting, my vision was narrowing, I was having difficulty breathing, extremely nauseous, felt like I was passing out, trembling.  Pharmacist helped me to lay down which took care of the nausea and relieved the passing out feeling.  Still had difficulty breathing for several more minutes.  BP was  100 over 80.  About 30 minutes before I could get up and sit in a chair.  Extremely weak.  It was two hours before I was strong enough to drive home.  Pharmacist offered several times to call an ambulance but since it was gradually improving, I declined.
Patient spiked temp to 104.2 within about 8 hrs of receiving 4m vaccines at a routine well. Before his fever came down he cried incessantly and had a ? seizure-got very quiet and his "eyes vibrated"-lasted a few seconds, then back to normal. Mom had underdosed TYLENOL for wt.
10 days after second dose patient experienced severe joint pain, MCP joint edema and severe fatigue. Workup including sedimentation rate, CRP., CBC and all other labs were unremarkable.
frequent dizzy spells; My blood pressure dropped to under 90/60; Many of the foods that I was eating around the time of the vaccine came back showing high sensitivities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: IN6206), in left arm and on 18Apr2021 as dose 2, single (Lot number: EW0153) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FOOD ALLERGY (non-serious) with onset Apr2021, outcome "not recovered", described as "Many of the foods that I was eating around the time of the vaccine came back showing high sensitivities"; BLOOD PRESSURE DECREASED (non-serious) with onset Apr2021, outcome "not recovered", described as "My blood pressure dropped to under 90/60"; DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "frequent dizzy spells". The events "frequent dizzy spells", "my blood pressure dropped to under 90/60" and "many of the foods that i was eating around the time of the vaccine came back showing high sensitivities" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, blood pressure decreased, food allergy.  Additional information: Timing is only correlated. My blood pressure dropped to under 90/60. This was discovered because of frequent dizzy spells. I went to a nutritionist for the low blood pressure, and she ran a A-95 and Food Safe Extended Food Panel. Many of the foods that I was eating around the time of the vaccine came back showing high sensitivities. The patient did not receive other vaccine in four weeks. Other medications in two weeks: Daily Multivitamin. AE treatment: Food elimination diet, nutrition changes. Covid prior vaccination: No and patient was tested post vaccination.
This spontaneous report as received from a physician refers to a 66 year old male patient. On 13-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not report). On 17-SEP-2013, the patient experience shingles on T12, L1, and right hip. Patient sought medical attention (visited physician's office) and was treated with Valtrex. The outcome of shingles on T12, L1 and right hip was reported as not recovered/not resolved. Additional information has been requested.
pt recv vax 28FEB97 on 8MAR97 pt stated vomited once 9MAR97 bump @ inj site;11MAR97 11mm by 3mm scab noted @ inj site;pt states there was a burning sensation @ inj site;
immediate burning pain at site of insertion, radiates down arm, into neck and shoulder blade.  has persisted X 3 weeks.  interferes with daily activities, sleep.  no improvement with heat, tylenol, ibuprofen.   no previous reaction like this to first 2 covid shots or any other immunization.  no rash, swelling , bruising.
SWELLING OF LYMPH GLAND UNDER LEFT ARM (ARMPIT); This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, non smoker, and antibiotics, and other pre-existing medical conditions included the patient does not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered in Left Deltoid on 31-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021 10:30, the subject experienced swelling of lymph gland under left arm (armpit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of lymph gland under left arm (armpit). This report was non-serious.
Started with localized itching to injection site left arm then advanced to generalized itching, then to tingling of tongue and difficulty swallowing given 4 tsp Benadryl at 10:20 am called 911 0.3 Epinephrine via epipen right lateral thigh 10:30 am  HR 84.
Pt developed confusion, decreased spontaneous speech, tremors, muscle rigidity and gait unsteadiness a day after getting the flu shot in a church.
Back pain several hours after receiving second dose of vaccine.  The next day 103 fever, abdominal pain and joint pain.
Swollen lymph nodes; Developed Shingles on his face; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported for a 32-year-old male patient (her fiance). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration at the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2  on 08Jan2021 for COVID-19 immunization. The patient developed shingles on his face on 31Jan2021 and swollen lymph nodes on 01Feb2021. The events were reported as serious (medically significant) and worsened. There were no investigation assessment. The patient had not recovered from the events at the time of the report.    Information on the batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the Company considers the event swollen lymph nodes is possibly related to suspect vaccine BNT162B2. Other than a temporal association, there is no evidence or argument to suggest a causal relationship between BNT162B2 and the event shingles, which is likely an intercurrent condition. 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 as received from a registered nurse refers to a patient of an unkonwn age  and gender. The patient's concurrent conditions and medical history were not reported. On 31-JUL-2015, the patient was inadvertently vaccinated with VARIVAX (Merck) (unknown strength and route) which expired on 30-MAY-2015. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
pt recv vax & 4 days later pt devel an erythematous rash & urticaria occurring only @ noc;pt was treated w/steroids, DPH & claritin;
Pt received 12 month Immunes on 10/24/19 Seen in our office due to rash 11/7/19 Blanching pink papular rash all over body Increase in groin, Also on buttocks Afebrile. Suspect MMR reaction cannot rule out viral exanthem Had sm amt bld from vagina
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative; (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 22Aug2023 to 27Aug2023.   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-202300291411 same patient/reporter; different drug/AE;
Dramatic irritability several hours after administration, accompanied by pallor and clammy skin, poor feeding and sleeping.  This lasted for at least 48 hours.  She received treatment for possible GE reflux when seen on 8/6.
Degraded thinking; shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: ew0173) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: er8734), for COVID-19 immunization, reaction(s): "Shortness of breath", "Degraded thinking". The following information was reported: MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "Degraded thinking"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath".  Clinical Course: The patient had the first 2 Pfizer shots: er8734 and ew0173. The patient might has side effect shortness of breath and degraded thinking.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202300063628 Same patient/vaccine/event, different dose;
Vaccine (PREVNAR) was administered 3/12/17, patient's face start drooping Wednesday night 3/15/17. Pt went to ER because she cannot feel her mouth 3/16/17. ER MD gave patient VALTREX 1g, Prednisone 20mg, erythromycin eye ointment.
"Covid Arm"  Red, warm to touch, triangular patch at injection site. Approximately 4.5 in X 3 inch .  More predominant red on outline edge. Appeared about 8 days after Moderna shot #1.  Today, 11 days after injection, red reaction patch is still visible and unchanged.  Photo available if needed.  No treatment has been utilized. My primary care physician has been notified of this reaction.
Sore throat (red) 9/28/16- evening, body aches 9/28/16- morning-day.
4 days p/vax devel urticarial rxn involving most arm;starting @ just below site of inj;
This is what the patient verbally reported to me. Shortly after he received his Moderna shot. The patient became short of breath, this shortness of breath started becoming worse. He told his sister he wanted to be taking to the emergency department.  On May 13, 2021- the patient presents with difficulty breathing and dizziness, dyspnea, weakness.  Denies CP.  Had the first moderna covid 19 vaccination today at 10:30 - then 50 min later had these symptoms, felt throat tightness and closing.  This has gotten better with laying down.   no rash, and no burning.  The onset was 6  hours ago.  The course/duration of symptoms is improving.  Degree at onset moderate.  Degree at present mild.  The Exacerbating factors is exertion.  The Relieving factors is rest.  Risk factors consist of chest pain, age.  Associated symptoms: denies chest pain, denies fever, denies chills, denies cough, denies nausea and denies vomiting.   CARDIAC: cardiology after noting complete heart block at home. Recently started wearing event monitor which alerted the doctor today that he appeared to be in transient three degree block yesterday. D-Dimer elevation doctor reviewed and confirmed and advised the patient to come to the ER. Patient had a pacemaker placed on 5/24/2021.  He states ever since than, his condition has been going down hill.  .
On 3/21, the upper left arm was very swollen and sore. On 3/22, there was a raised, itchy, hot rash approximately 2 inches under the injection site. On 3/23, all symptoms were gone. On 3/27, hives, redness, itchiness, and heat (like a sunburn) developed in the same spot 2 inches below the injection site.
This case was reported by a nurse via sales rep and described the occurrence of body temperature increased in a female patient who received FLUARIX QUADRIVALENT 2017-2018 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a day after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced body temperature increased, general malaise and nasal congestion. On an unknown date, the outcome of the body temperature increased, general malaise and nasal congestion were unknown.  The reporter considered the body temperature increased, general malaise and nasal congestion to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of prefilled FLUARIX QUADRIVALENT 2017-2018 season. In the evening after flu shot, the patient experienced elevated temperature, general malaise and the patient felt congested. The patient felt the event was related to the product. The reporter was agreed for providing follow up information. The second event occurred in the same department. This case has been linked with US2018GSK155553, reported by the same reporter. Lab Comments: On an unknown date, the patient's body temperature was found to be elevated.
Very red where shot was administrated. Red rash began spreading down arm and arm hurt. The next day Saturday, 2/21 the rash began spreading even more and arm began swelling. On Sunday, 2/22 there was less pain but the rash was still very red and spreading. On Monday, 2/23 the rash and swelling was still there and the pain had increased to a level 10. I went to Urgent Care after work. Had an infection and an allergic reaction to shot. Given an antibiotic (Dicloxacillin).