chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 07 November 2013 from a non-health care provider from an unverified internet source. The reporter for this case is the same as case number 2013SA114788. A 7 year-old female patient (date of birth not reported) had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) at her annual checkup. The patient was reported to have no pre-existing health conditions and was a very healthy child. The patient developed a severe headache and fever one day after vaccination. Three days later, the patient stopped breathing and died without warning in her mother's arm. Diagnostic and laboratory testing were not reported. No further details were available at the time of the report. The patient's outcome was fatal. Documents held by sender: None.
Miserable sore arm since 8/23 and left shoulder pain ongoing that has not subsided
AFIB event 12 hours after second injection on 7 March 2021. Significant chest pain.  Skin hypersensitive.  Constant headache. Dizziness. Heart/chest does not feel right even under minor exertion.  Feels like heart rate is much higher than it should be.  pores close up and hands are very dry feeling. Skin all over my body feels like hot little pin pricks.  Skin very sensitive to wherever clothes touch.  Deep under skin there is a faint flushingmost doctors cannot see it.  Face flushes. Eyes feel dry.  Nose dries up and sometimes it is hard to breathe.  Dr prescribes blood thinners but my skin hypersensitive when I attempted to take  Pradaxa, Eliquis, Xarelto, and certain foods do the same thing. It feels like my immune system is pretty much fighting ME.  Raging Tinnitus.  Now, 1 year later the skin sensitivity and inability to take blood thinners has abated.  Irregular and very fast heart beat and AFIB events continue to happen at a much greater rate than before 2d Moderna shot.  Tinitis is still much worse than it had ever been before.  Constant cough.  Swollen ankles.  Something happened to my heart.  I wake up with heart rate over 100 BPM.
This spontaneous report as receivef from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 22-DEC-2014 the patient was vaccinated with ROTATEQ, oral (Lot # not reported) for an unknown indication. And the patient received ROTATEQ improperly stored and administered. No adverse event were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a certified medical assistant, and refers to an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 13-SEP-2013, the patient was vaccinated with a dose of GARDASIL for prophylaxis. On 11-DEC-2018, the patient went to physician's office to receive one dose of GARDASIL 9 lot # R003557, expiration date 20-NOV-2020, for prophylaxis (inappropriate schedule of vaccine administration and interchange of vaccine products). It was unknown if the patient received the dose of GARDASIL 9 (circumstance or information capable of leading to medication error).
DIZZINESS; CHEST TIGHTNESS; DRUNK FEELING; CHEMICAL TASTE IN THE BACK OF THROAT; NAUSEA; This spontaneous report received from a consumer concerned a 38 year old. 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: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced chest tightness. On 07-APR-2021, the subject experienced drunk feeling. On 07-APR-2021, the subject experienced chemical taste in the back of throat. On 07-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness on 07-APR-2021, and had not recovered from dizziness, nausea, drunk feeling, and chemical taste in the back of throat. This report was non-serious.
Information has been received from a registered nurse referring to an adult patient of unknown age and gender. No relevant medical  history or concurrent conditions were reported. On an unknown date in JUL-2014 the patient was vaccinated with 0.5ml dose of pediatric formulation of RECOMBIVAX HB (lot# and expiration date not reported; intramuscular) (underdose). Then the patient received two doses of pediatric formulation RECOMBIVAX HB (drug maladministration) for the second dose in NOV-2014 (inappropriate schedule) and the third dose in jAN-2015. No adverse effects were reported. Additional information has been requested.
Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2019SA059185 (same reporter). This case involves a 4 months old male patient who experienced received vaccine PENTACEL outside of the shipping standard. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTATEQ for Immunisation. On 26-Feb-2019, the patient received a 0.5 ml  injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ065AAA (expiry date: 16-Oct-2020) via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. The PENTACEL shipment was received 25-FEB-2019 and shipped on 20-FEB-2019. It was reported that no adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Multiple Hives, Bilateral from chest to waist Treatment OTC Benadryl. Prednisone .  If systems worsen go to ER.
5th day post vaccination possible seizures. Duration - 4 second. 6th day another seizure duration 6 seconds. Totally asymptomatic otherwise. Today normal exam.
Dizziness, Myalgia, Fever, NauseaVomiting, feels hot and cold, sweating, chills Narrative:
Left arm was sore and body aches.  Did not know pregnancy status at the time of the injection
No additional AE reported.; VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age.     On 06-FEB-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml, lot #W012163, expiration date 12-APR-2024, strength was not provided) for prophylaxis (Product storage error). Temperature excursion was reported as 7 Fahrenheit, time frame 1 hour. There was no previous temperature excursion.. No additional adverse event was reported.
several fevers a day, bad headaches with fever, sore throat, stopped up nose or runny, weak, upset stomach and vomiting, pale skin, cried because generally miserable most of the time.4/7/09-records received for DOS 3/24/09-office visit 3/24/09-C/O right ear pain increased temperature for about a month, headache, vomiting nausea all started after Gardasil injection. Now in clinic with C/O runny nose, sore throat, headache, right ear pain, sinus drainage for few days. One month ago received 2nd gardasil vaccine and started having fever. Assessment: right sided external otitis. Acute sinusitis. Office visit 4/1/09-No fever doing well, no hearing problem. Signs and symptoms improved. Assessment: right sided swimmer's ear improved. Acute sinusitis improved.
rash reported per mom x 24-48hr;no DPH;resolved spontaneously;
"very strong" hip pain on both sides; she has neck pain on the left side; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (at the age of 36-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced "very strong" hip pain on both sides, and had neck pain on the left side where she received the vaccine. The patient received treatment for the events, the therapeutic measures were tried massages and applied on all sorts of creams. The patient also stated that she thought of cancelling the second dose appointment. The outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Given Flu vaccine 10/3/2016. 10/5/2016 started to have itchy, thick tongue and throat. She also developed itchiness and redness of scalp, head, neck and chest and face. Took BENADRYL and PRILOSEC. These symptoms continued for approximately four days. All issues resolved.
HPI: Patient is a * year old * who presents following administration of a single dose of J&J COVID19 vaccine in the left deltoid.  About 20 minutes following administration of the vaccine, the patient started to experience numbness in the left shoulder to the left neck and post auricular region.  Patient denies allergies to medication, food, and other vaccines.  She states she has never had a similar experience.  She declares a past medical history of asthma that is controlled with rescue inhaler and oral medication.  She has not taken the medication for the past week and uses her rescue inhaler 2-3 times per week, particularly when she exercises or coughs too much.  She affirms numbness of the left neck, left shoulder, She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.     Exam (update as needed): GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: PERRL, EOMI ENT: Decreased touch sensation in the left post auricular region and left posterior neck region.  Normal ROM and 5/5 strength of the neck. Right ear normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry.  No erythema or edema of the injection site. MSK: FROM of the bilateral upper extremities and neck, MS 5/5 bilaterally NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady.  Decreased sensation of the left post auricular region, left posterior neck region, left shoulder, left bicep compared to the contralateral side.   Clinical Impression/Field Tx: Possible peripheral nerve injury secondary to vaccine administration.  Patient not displaying active signs and symptoms of anaphylaxis.   Patient demonstrated ability to adequately control airway and secretions.  The patient was experiencing decreased sensation on the ipsilateral side of the vaccine site compared to the contralateral side.  Muscle strength was 5/5 bilaterally.  CN II-XII were grossly intact.  Patient offered further evaluation by EMS, however, patient declined as she has an appointment with her PCP on Monday and would prefer to address it there.   Instructed patient to consult their PCP regarding the post-vaccination reaction.  Patient states she has an appointment on Monday.  Patient instructed to go to emergency department should the area of decreased sensation increase in size or if they develop chest pain, difficulty breathing, difficulty swallowing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention.     Medications administered: None   Disposition:  Home
Swollen lymph gland under right armpit, Muscle pain in right shoulder, Body aches, Chills, Extreme fatigue, and Low grade fever.
Right upper arm swollen, warm to touch, pain with movement (deltoid muscle injection site to elbow).
Approx 9:28am client rec'd Td and IPV L arm and became quiet slow to respond. BP difficult to hear. Reclined with feet up. BP 124/68 P 80 R 16. Reclined 20+mins, ate juice, crackers, denied pain, N/V stated does not like shot. Given hep B vaccine R arm without incident. D/C amb. alert and oriented BP 118/64 P 82 R 16 on D/C.
Mother reported child had temp >107 and was taken to ER. ER doctor said of all previous vaccines given it was most likely the DTaP. Mom refuses to let child receive another DTaP.
I started spotting  and then started my period almost 2 weeks before I should have. The spotting started the next day. I bled extremely heavily. My periods are normal 28 day cycles every month.
4hr post vax high pitched cry;crying-would not stop-ran 103 temp-APAP q 4 hr; mom took pt to ER, feet blue, pale, incoherent, flushed, would not eat or drink, would stare;
heart rate low; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate low) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced BRADYCARDIA (heart rate low). At the time of the report, BRADYCARDIA (heart rate low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Heart rate: low (Low) low heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Around 5 minutes after immunization was given, child presented with one hive 3/4 of in inch in size at the site of injection with surrounding redness. Treated with ice pack at the site and the one hive and redness went away. Provider also gave BENADRYL. Child monitored in clinic for 20 minutes prior to leaving.
Redness, itchy, swollen and warm to the touch, near/around the injection site, about 2-3 inches affected area as of today 5/17/21. Also, underarm is a little sore.
Initially started as squeezing in lower back around the kidney area approximately 1 hour after receiving the vaccination. After one day, strong spasms were occurring in lower back and legs and started to subside after 1 week. I was unable to walk properly without Advil and muscle relaxing topical creams. It was difficult.
Short of breath; Weak; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Short of breath), ASTHENIA (Weak) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNEA (Short of breath), ASTHENIA (Weak) and PYREXIA (Fever). At the time of the report, DYSPNEA (Short of breath), ASTHENIA (Weak) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
I just wasn't feeling well. I thought maybe the blood pressure meds I had been put on 6 wks prior were not working right, so I went to the doctor. They did bloodwork. My red blood cells are not making mature ones.  RDW 11.7 Low % 12.3-15.9 01  eGFR If NonAfricn Am 77.4 mL/min >60.0 01  Units = mL/min/1.73 m2.GFR results <60 for 3 months or  longer: Chronic kidney disease.GFR results <15: Kidney  failure.If African American is indicated, calculation  includes multiplier of 1.159.  BUN/Creatinine Ratio 11 6-25 01  Sodium 131 Low mmol/L 136-145 01  Potassium 4.1 mmol/L 3.5-5.1 01 I haven't ever had kidney issues before this. Hemoglobin A1c 5.8 High % 4.0-5.6 01  5.7-6.4: Increased risk for diabetes mellitus. Consider  repeat testing and/or correlation with fasting glucose or  oral glucose tolerance test.  >=6.5: Consistent with diabetes mellitus. Consider repeat  testing and/or correlation with fasting glucose or oral  glucose tolerance test. They put me on metformin for it.
having a sour taste in mouth the next day; bumps on lower extremities; itching on lower extremities; Initial information was received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves 68 years old female patient who experienced itching on lower extremities, having a sour taste in mouth the next day and bumps on lower extremities while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Mar-2023, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine at dose of 0.7 ml lot number not reported via intramuscular route in the left deltoid for Immunisation.  On 16-Mar-2023 the patient developed a non-serious event of itching on lower extremities (pruritus) and bumps on lower extremities (skin swelling) following the administration of influenza quadrival a-b high dose hv vaccine.  On 17-Mar-2023 the patient developed a non-serious event of having a sour taste in mouth the next day (dysgeusia) 1 day following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (itching on lower extremities, having a sour taste in mouth the next day, bumps on lower extremities).  At time of reporting, the outcome was Not Recovered for the event itching on lower extremities, having a sour taste in mouth the next day and bumps on lower extremities.
This spontaneous report as received from a consumer refers to a 81 year old male patient with multiple myloma and prostate cancer. In 2010 the patient was vaccinated with ZOSTAVAX, subcutaneous. On 20-DEC-2012 patient's physician diagnosed him as having shingles. Patient had spots on right ear at first and developed into an itchy rash on his back and on to his chest all over. It went to his beltline. The outcome of shingles was unknown. The relatedness for shingles was not reported for ZOSTAVAX. Additional information has been requested.
no appetite; no energy; in bed for 3 days; sluggish; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), ASTHENIA (no energy), VACCINATION COMPLICATION (in bed for 3 days), SLUGGISHNESS (sluggish) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (no appetite), ASTHENIA (no energy), VACCINATION COMPLICATION (in bed for 3 days), SLUGGISHNESS (sluggish), PYREXIA (fever) and MYALGIA (sore arm). At the time of the report, DECREASED APPETITE (no appetite), ASTHENIA (no energy), VACCINATION COMPLICATION (in bed for 3 days), SLUGGISHNESS (sluggish), PYREXIA (fever) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided by the reporter.
she feels terrible.; terrible headache; drained; not energetic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she feels terrible."; HEADACHE (non-serious), outcome "unknown", described as "terrible headache"; FATIGUE (non-serious), outcome "unknown", described as "drained"; ASTHENIA (non-serious), outcome "unknown", described as "not energetic".  No follow-up attempts are possible. No further information is expected.
Patient experience sudden cardiac arrest approximately 2 minutes after vaccine was administered.  Paramedics on scene provided CPR and defibrillation and pulse was restored.  Patient was regained consciousness prior to transport to the hospital.
Patient passed out in the hallway about 3 minutes after receiving vaccines. Mother was with him at the time. She reports that he fell face first and hit his head on the carpet. She says he was out cold for about 6 seconds. Myself and the other nurse were called to the hall to assist. Patient was found lying on the floor with his head in his mother's arms. He was conscious and speaking. He had a laceration on his forehead. I called 9-1-1 to report the incident while the other nurse applied pressure to the wound and had the patient drink Sprite. The patient was escorted out on a stretcher by ER staff.
The pt came to the clinic on 05/30/2002 with red and swollen left thigh. Sent to ER per MD.
eye was kind of distorted, wavy, weird looking; she was kind of sleeping whole day; headache; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (eye was kind of distorted, wavy, weird looking), SOMNOLENCE (she was kind of sleeping whole day) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney ablation (Partial Kidney removal). Concurrent medical conditions included Arthritis.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced METAMORPHOPSIA (eye was kind of distorted, wavy, weird looking), SOMNOLENCE (she was kind of sleeping whole day) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, METAMORPHOPSIA (eye was kind of distorted, wavy, weird looking), SOMNOLENCE (she was kind of sleeping whole day) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.