chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BREAKTHROUGH INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine was not applicable. The outcome of breakthrough infection was not reported. This report was non-serious.
This spontaneous report was received from a pharmacist via company representative who reported 3 individuals (unknown gender and age) who in approximately 2014 (reported as over the past 3 months) received a dose of ZOSTAVAX (Lot #, exp date, dose and route not reported). Concomitant therapy was not reported. In approximately 2014, the patients were subsequently diagnosed, per unspecified physician, with shingles. It was unknown if the patients sought medical attention. The patient's outcome for shingles was unknown. Additional information has been requested.
Pt vaccinated with PNU IMUNE 23 2days later developed headache & chest pain. Went to PMD pleurisy.
I have been diagnosed with shingles as of yesterday, March 8, 2021. Symptoms started last Wednesday, March 3, 2021: feeling of pulled back, itching underneath left breast and left side by bra line. Itching continued through the weekend and small sores developed. I treated with hydrocortisone cream @ 1% and and neosporin for 3 days. I called my primary care physician and his colleague diagnosed with jock itch. A few hours later I called my OBGYN and after looking at pictures I submitted to her office, she diagnosed me with shingles. I am now on Valtrex 3 times a day.
I have reported to the program as well, but something else occurred after that was concluded. I had mild-moderate soreness in arm at injection site, red rash 24 hours later and welt. Treated with Cortizone and ibuprofen. Healed after day 4 of shot. Woke up day 10 after shot and it was back and much more red this time, as sore again as first time, even though had been pain/sore free. I'm hearing this happens a week or so after the Moderana shot specifically. Thought I would report. Treating with same as first treatment, at home.
Pt recvd 3 doses of Engerix-B vax & 4DEC91 found to be a non-seroconverter;
Severe local reaction, redness, and swollen from deltoid half way to elbow of the left arm. Treatment: ice and Tylenol.
vaginal discharge that was abnormal; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced vaginal discharge that was abnormal and it worried her so she didn't go back for the second dose. Patient was inquiring about additional information for receiving the second dose of the Pfizer Covid-19 vaccine outside of the recommended time frame. Outcome of the event was unknown at the time of reporting.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
improperly stored vaccine in ude; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-SEP-2020, the patient was vaccinated with improperly stored vaccine, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot#: T013540 has been verified to be a valid lot number, expiration date 17-OCT-2021, albumin status: rHA (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (6 to 14 Fahrenheit degree (11.7 F)) degrees Fahrenheit for 25 minutes. Data logger was involved. There were no previous excursions reported.
Patient is an employee  and  received the Covid Vaccine @1045AM and was observed for 15 min.  Upon returning to her desk, she began to "feel bad" "heart racing" about 11:30. She stated she had read more on the vaccine and became more and more "scared".  She has no hx of High blood pressure or Diabetes. Does have HX of Asthma. Takes only singular and omeprazole. Denies taking anxiety meds or previous anxiety episodes. BP 240/140, Resp 22 Pulse 110 skin was moist and clammy to touch. Several  staff members assisted and observed her while the Clinic Vaccine staff was notified. 11:45 Clinic staff responded, BP down to 160/90 HR 100 Pulse Ox 98%, BS 143. Patient stated she was better, her husband was in route to take her home. She continued to be observed by staff at 1200 she stated she did not feel well again, BP 240/138, P 110 R 24. At this time the clinic staff responded again, EMS was called and patient as assisted to a bed within the  training area.  Her husband arrived 12:05 BP 160/100, P 108, R24 PO2 96%. 12:10 BP 160/100, P 100, R 24 PO2% 99% states feels better.  EMS arrived but patient choose to go to hospital per private car with husband.  Her breathing was unlabored, she stated she felt better but was going let her husband take her to ER.  She was assisted to his truck with w/c and facility staff.
This spontaneous report as received from a nurse practitioner refers to a 20 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 15-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Would not walk or crawl or stop crying per mom, No redness, no bump but terrible sore. Child terrible fussy. Per mom would not even let her touch area at all.
Breakthrough case admission after 2 vaccines Moderna 4/2/21 lot# 043B21A;  Moderna 12/14/21 lot# 060H21A
Received my third GARDASIL shot. Within 6 hours of receiving my shot, I had a temp of 102.7, severe aches and body shakes. In the following 48 hours my temperature decreased down to 101.2 but intense headache and dizziness occurred.
Excessive sleeping for 2 1/2 days, limp, groggy very pale and cold, scrotum dingy gray color, staring (no blinking), frothy spit, weak cry, unfinished bottles 5 days. Constricting arms and legs grunting three days arching head backward, runny nose, coughing
had a stroke; got real dizzy; he had headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced DIZZINESS (got real dizzy) and HEADACHE (he had headache). On 17-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency and AMLODIPINE on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke), DIZZINESS (got real dizzy) and HEADACHE (he had headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 17-Jun-2021, patient visited emergency room and got discharged the same night.  Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.; Sender's Comments: Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received HAV (Havrix) (batch number 3TZ52, expiry date 26th June 2020) for prophylaxis.   On 28th October 2021, the patient received the 2nd dose of Havrix. On 28th October 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered an expired dose of the Havrix vaccine, which led to expired vaccine used. The batch number and expiration date were only for Havrix dose number 2.  No information for Havrix dose number 1 was given at the time of the report. The reporter consented to follow up.
Large swelling, burning, red, itching, aches. Started a few hours after vaccinations, treated w/ ice on Thursday night, and ADVIL daily. Swelling, redness, slight burning still continuing. Still itching. Headache intermittent. (R) arm edema where vaccine placed.
Information has been received from a registered nurse concerning a 6 year old white female, with no pertinent medical history, birth defects, or allergies, who on 13-SEP-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 05-APR-2007 the patient presented with a two day history, approximate onset 03 APR 2007, of an itchy rash on her back, chest and the back of her neck, which now was spreading to her arms and legs, along with a headache and fatigue. On 15 APR 2007 the patient had recovered. Additional information is not expected.
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 10:00 as dose 1, single (Lot number: EL1283), in right arm, on 09Feb2021 at 10:00 as dose 2, single (Lot number: EN5318), in right arm, on 08Oct2021 at 13:00 as dose 3 (booster),  single (Lot number: EW0191), in right arm and on 14Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive, notes: after having tested positive previously on 06Jul2022; (12Jul2022) Negative, notes: On 12Jul2022 I had tested negative from my first Covid experience; (17Jul2022) Positive, notes: Tested positive again on 17Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are needed. No further information is expected.
Discharge Provider:  Primary Care Provider:  Admission Date: 9/5/2022 Discharge Date: Sep 7, 2022  PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: Patient is a 77-year-old female with PMH significant for hypertension, dyslipidemia, GERD, history of encephalitis, recently diagnosed NPH and outpatient evaluation with the LP on 09/01 presents to the hospital generalized weakness and increased confusion.  Family noted drastic improvement right after LP was done but subsequently quickly reverted back to her baseline. She was noted to have COVID at the time of admit. Patient was admitted for further workup, COVID was incidental and did not need any therapeutics.  End of isolation would be 9/15.  She can check with PCP to see if she would still qualify for Paxlovid.  Patient was asymptomatic.   Neurology was consulted, who reiterated that her presenting symptoms are consistent with her diagnosis of NPH, needs no further workup and recommended her to follow-up with her established movement disorder/Neurology office for further shunt evaluation. Per family's discussion with her neurologist, her Sinemet dose was reduced to 1.5 mg 3 times daily.   patient Neurology communicated this to patient's family and also a taper. Due to her soft blood pressures, controlled blood pressures, her Hyzaar was reduced to half usual does with instructions to follow-up with PCP. PT/OT suggested home with home physical therapy and this was arranged.  Discharge home 9/7.
Redness at injection site size of a dime. Tender to the touch. Lump under injection site.  Warmth and swelling at injection site
Arm numbness that progressed to numbness in fingers and legs (intermittent, tingling); headache and light-headedness. Pt was recommended to f/u with neurology. Still at home recuperating
quadracel was administered to a 3 yr old patient with no other reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no other reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Aug-2022, the patient received 0.5 mL dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (formulation, strength, lot number not reported) via intramuscular route in the left vastus lateralis for immunization.  On 08-Aug-2022, the patient was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no other reported adverse event (product administered to patient of inappropriate age).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Janssen COVID-19 Vaccine EUA Full body aches Nausea  Fever - 101 degrees  Full body chills Stabbing joint pains Severe fatigue  Sever headache  Pain and swelling at injection site
August 16, 2021: Symptom - Extreme fatigue August 17, 2021:  Symptom - Chills, pinching headache.  Started taking Tylenol 1300mg. every 8 hours & Airborne 1 tablet in AM & PM daily. August 18, 2021:  Symptom - fatigue, loss of appetite August 19, 2021:  Symptom - sore throat, inflamed gland August 19, 2021:  Urgent Care visit - negative rapid throat culture, administered Covid PCR test. Separated and isolated from my husband.  He made an appointment to get tested, too.   August 20, 2021:  No symptoms.  Only loss of appetite.  Took short walks outside. August 21, 2021:  PCR Test results Positive.  Shocked.  I am diligent about washing hands, masks, and sanitizing.  Continued to walk outside. 18.  Continued my daily regimen of vitamins, tylenol, and airborne. My diet consisted of fruit, vegetables, protein, grains, and an occasional sweet.  My husband would check to see if I ate.  I would try to eat B,L, D, even if I wasn't hungry just to keep my strength up.  I could no longer tolerate a CBD gummie.  I found them no longer effective while I had the Covid virus.  I PCR retested on August 26, 2021.  My result was negative.  On my short walks I felt as though the oxygen I inhaled wasn't being absorbed into my lungs and experienced a slight headache.  I would walk home and lay on the floor in the proning position.  Breathing issues would subside.  I wouldn't lay around in bed.  I walked outside every day.    I continue to have these breathing issues at times and loss of appetite.  It's not consistent.  It can happen on any given day or time.  Overall, my symptoms were mild.  I only had the symptoms I listed and only had them on the days I listed.  For instance, I only had the chills on August 17, 2021.  Not on any other day.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD), Additional Details: Patient experienced severe pain, swelling at injection site. Mother is a healthcare professional and received an antibiotic from a physician for it.
painful shoulder right after shot, swollen shoulder and arm for three days.  muscle and tendon pain  has been going on now for over 6 months. lost all tricep muscle and most bicep.  we are just now getting some muscle back after losing over 30 pounds in november 2022.
Severe headache, muscle , joints painful , extreme fatigue , stomach upset  , chills,
This spontaneous case, initially received on 09-Mar-2017, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced acute rheumatological events (medically significant, outcome: not reported), extensive cervical [reconstruction] (outcome: not reported), degenerative joint disease / osteoarthritis (outcome: not reported), [extensive cervical] reconstruction (medically significant, outcome: not reported). It is not known whether the patient's osteoarthritis, degenerative joint disease and extensive cervical reconstruction occurred before or after the patient received the flu vaccine. Sender's Comments: Listedness: Brand of Influenza vaccination not specified. Assessment according to CCSI for CSL's Inactivated Influenza Virus Vaccine, rheumatic disorder, spinal operation, osteoarthritis and intervertebral disc disorder are all unlisted. Causality: Unassessable. Time to event onset following vaccination, patient age, medical history, sequence of events and event description not provided. The events described are suggestive of as long standing degenerative disorder unrelated to vaccination. Overall there is insufficient information, hence causality is unassessable.
Pt passed out for 5 seconds after vaccines were given. Pt was awaken but disoriented, vital signs were within normal limits.
Within about an hour, I started severe arm pain at the injection site.  That got worst over the next 5 day.  Then it went away.  About 2 weeks later, I wake up the severe shoulder pain.  I could not even move it.  About a week,  my pain in my shoulder got so severe.  I contacted my doctor about this.  He thought that I had rotator tendonitis. He order to start physical therapy.  The physical therapist thought that I might have a freeze should.  So he order a MRI, showed that I had characteristic of a freeze shoulder.  He also though it was due to the vaccine.  He told me that I am looking for about 18 months recovery time.
Tested NAAT positive for COVID 8/31/21 after being fully vaccinated.
This is a non-serious spontaneous case, initially received from other health professional (nurse) on 18-Jan-2018, concerning a 39-month, female child. The patient's medical history and concomitant medications were not reported. On 12-Jan-2018, the patient (less than 4 years of age) was given FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195129, expiry date: 31-May-2018). It was reported that the patient did not experience any adverse event. The reporter assessed the event inappropriate age at vaccination as non-serious.
sleepy; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and FATIGUE (Very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (Very tired). At the time of the report, SOMNOLENCE (sleepy) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-008796 (Patient Link).; 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.
Mild cough with phlegm on day 2 after vaccine. Cough worsened on day 3 and became painful to cough by end of day 3. Horse voice on day 3.  Some nausea started early on day 3 and came in spurts through the day. Slight chills on day 3.