chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client reported shortness of breath 2hrs after vaccine was administered. Per client it was intermittent and lasted a total of 3 hours. Client denied swelling or feeling throat close. Per client did not take any medication and resolved on its own. Medical history of hypertension and takes Zestril. No known allergies.
About 5pm after I began feeling achy and fatigued. The next day after I  developed  the tingly,  pins and needles sensation that came and went in both legs, my face, arms and both hand area which I am still experiening today but not as frequent as it was when it began.  When it happens its not always in the same spots and  doesnt occurs at the same times its as if it alternates and now I also get a hot sensation at the top of my ears  periodically which doesnt last very long but it does occur
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered inadvertently one single dose of VARIVAX subcutaneously, Lot # N002203 with and expiration date on 19-JAN-2019 for prophylaxis (strength was not provided) that had been improperly stored during 1 hour at 10°F. Previously, there was a temperature excursion for 1 hour at 9°F. Concomitantly, the doses of VARIVAX were reconstituted with a properly stored sterile diluent (manufacturer unknown). The call was because of a data logger and no adverse effects were reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1707USA005855.
Local reaction - swelling/redness within 24 hours of injxn at site of Hep B vaccine.
Apprx 10 after injections patient, while sitting on exam table, all of a sudden appeared to passout stiffen up and fell on her back with legs straightout, arms on her chest with fingers in eractic shapes and stiffened, eyes closed, her face and mouth tight as if she presented a seizure posture.  Her skin was very pale/white.  I yelled at her, lightly smacked her first, but no reaction whatsoever.  I opened exam room door and yelled for help.  Aides came in, applied wet cold paper towels to her forehead, and one used a flinch took on the bottom of her feet and sides of her legs without any normally expected twitch/movement.  In about a half hour, she started mumbling in her speak, barely audible, and said she could not not feel her legs from the middle of both upper leg thigh areas down to her toes.   Again the flinch tool was used and no reaction whatsoever.  It took a while for to sit up, and when attempting to stand was extremely weak and wobbly.  She reached a point where she felt she could go home and was wheeled to our car by a nurse.  I was NOT made aware of any possible or known side effects, and when I asked the Dr I was told there are no known effects.  However, the After Visit Summary report says to the contrary in particular with the HPV.  July 30th patient had slept until apprx 2pm.  I and my wife often checked on her while sleeping in order to determine if there was any stress to be noted.  She was very weak and wobbly when standing and walking.  She complained of mid-center chest pain.  I called Dr's office, spoke with her nurse for whom said that Dr stated patient may have been having psycho-systemic reaction to the shots, and to keep an eye on her.  If conditions worsen then take her to the ER for further testing.  However, patient never worsened, but never methodically started to recovering as her weakness continued into today (July 31, 2019).  Her vitals were taken at home but no off-scale indications of BP, temp, or pulse.
Day after vaccination patient reported arm was red and warm to the touch at injection site. Advised the patient to see her PCP. Called her to follow up and patient reported that she cancelled the PCP appointment because the reaction went away on its on a couple of days later.
Myalgia Pain at injection site(right arm) Per supervisor report. "second dose 3/10/21- reports body aches and pain at injection site"
Day 1 (11/5/13) - Site of injection red, swollen, and tender plus fever 101.1. Day 2 (11/6/13) - Headache/chills. Day 3 (11/7/13) - Still not feeling good but fever resolved.
About a week after her vaccine she went to rehab and exercised which she then developed leg pain, she said it only lasted that day and has since gone away.  She believes that was from the exercise.  A few days later she experienced diarrhea without having any cramping or feeling ill, just out of the blue for about 6 hours and then it went away.  She has been tired/ fatigued the entire time.
17 cm x 10 cm area of redness; Mild warmth; Induration centrally w/o fluctuance 1 day S/P injection.
Made an appointment at local Pharmacy to obtain COVID booster (Pfizer) and Shingrix. Within a few days. Experienced extreme issues with balance. Two months later I am beginning to feel better. Have had appointments with my cardiologist and neuologist.
Pt recvd 3 Hep B doses given 25JUL89, 29AUG89, & 23JAN90; 16MAR90 titer=80; 20FEB91 titer=5;
Received J&J on 3/18/21. Admitted, COVID positive, on 4/6/21 for respiratory failure with hypoxia, COVID 19 PNA
red rash from left earlobe down the left jawbone, hives on right side of neck and left side of neck, also both arms Rash started 2 hrs. after shot, then shortly after hives on neck,and about 1 hr. later the arms
Tickle in throat / throat itching, Can't get a full swallow, anxious, jittery
Red bump that appeared 7 days after vaccination: on 3/23 and lasted for 2 days.
one patient received expired ActHIB/ No AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA242256 same reporter.  This case involves a 15 months old female patient who received 0.5 mL dose of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] Lot UI859AAA via intramuscular route in the right thigh on 26-Jan-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  It was unknown whether the patient had any adverse 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 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.  Documents held by sender: none.
CDC Reports: 3 mo infant received DTP/OPV on 31OCT89 and died 7NOV89.
Client stated he felt dizzy after vaccines. Stated he was dizzy all day while sitting or getting up too fast. Stated he also felt a little nauseous, but did not feel like he was going to emesis. Reports he felt fine next day and since then.
Only adjuvant used; Only adjuvant administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2022, the patient received Shingrix. On 5th December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's Comments: The pharmacist reported that the patient accidentally received only the adjuvant of the Shingrix. The health care professional did not have any information about the patient or the vaccine (lot number or expiration date) since the call was done on behalf of the HCP that administered it. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient accidentally received only the adjuvant of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-NOV-2015 17:03, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.1 and 2.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unspecified date prior to 22-APR-2009 the patient was vaccinated with the first dose in vaccination series of GARDASIL (intramuscularly, dose and lot numbers were not reported) and subsequently was administered the second and third doses of GARDASIL (intramuscularly, doses and lot numbers were not reported) on 22-APR-2009 and 29-06-2009 respectively. The patient was administered a fourth dose of GARDASIL (intramuscularly, dose and lot number were not reported) on 18-JUL-2013. No adverse effect was reported. Additional information has been requested.
My entire upper arm swelled, turned red and became hard to touch. Was very tender and sensitive to touch for 3 days after administration.
Very little arm soreness; a few hours of lightheadedness the day of and the day after.  Nothing at all serious.
Mom called clinic on 8JUL91 stating pt had intermittent nausea, vomiting x 3 days, diarrhea, eating poorly; recvd immun 1JUL91; advised to continue fluids as tolerted, if becomes febrile see MD;
Patient was in office for medication check appointment. Patient received flu vaccination at conclusion of visit. Patient proceeded to checkout, accompanied by father. Patient then passed out while standing for checkout and hit back of head on floor. From progress note by PCP, "Patient seen and reassessed multiple times after having a syncopal episode immediately outside of the building after flu vaccine. He struck his head and had a LOC.   Initially confused and amnestic. This resolved after about 45 min. However continued to be somewhat pale with an escalating ha(no hx of migraine) where he became photophobic. He continued to have orthostatic dizziness and nausea and vomited about 2.5 hours after incident.   Got ibuprofen in the office about 45 min prior to emesis without sig improvement in ha.   Decision made to go to er -- dad to transport directly to hospital by car as is his preference.  agree that he is stale enough with stable VS.   Phone call placed to  NP in the er, who is expecting his arrival"
My menstrual cycle does not come on its own. My last regular cycle began on the same day at my 2nd shot in March. I take a hormone pill every 40 days to start my cycle.
Found unresponsive on the floor 19 hours after receiving the vaccine.  Transported to hospital.
Redness and some swelling in upper arm, generalized aching in arm. Heat in arm extreme fatigue. Happened day after then got.
I had a very strong immune response to my booster shot. I was in bed with fever, aches, chills, headache and as my symptoms subsided I noticed a ringing/buzzing in my ears. I had never experienced anything like this and assumed it would go away. It never did. I have been to numerous doctors and there is no solution. I understand that causality is very hard to establish, but I thought that it was important to report this as I do think it is linked to the vaccine.
ALLERGIC REACTION, SUBSEQ 4/7/2022 NONTRAUMATIC ACUTE KIDNEY INJURY  ALLERGIC REACTION, SUBSEQ 4/7/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  ALLERGIC REACTION, SUBSEQ 4/7/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  ALLERGIC REACTION, SUBSEQ 4/7/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  ALLERGIC REACTION, SUBSEQ 4/7/2022 BACTEREMIA    PULMONARY ARTERY HTN  ALLERGIC REACTION, SUBSEQ 4/7/2022 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE
Fever, muscular pain, dizziness, headache, heaviness, changes in sense of smell.
pt recv vax 11DEC96 & next morning pt woke up w/red bumps all over body that itched;sx persisted for approx 5 days;pt recovered from sx;
Vaccine administration error. The patient is 12 yrs old and received moderna mRNA vaccine as a booster. He is experiencing fatigue and some chills.
On 11/15/06 patient had red swollen area-tight hard area in middle size of silver dollar; also took to Dr. on pm of 11/15/06 went back on 11/16/06 to see MD-was given Prednisone 20 mg po bid x 2d; 20 mg/d x 2d and 10 mg 1d x 2day- Keflex 250 mg po tid x 7d
Late menstrual cycle not due to pregnancy  with extreme bloating and tiredness./ No chance of pregnancy; Late menstrual cycle not due to pregnancy  with extreme bloating and tiredness./ No chance of pregnancy; tiredness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 05Jun2021 12:00 (Lot number: UNKNOWN) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OLIGOMENORRHOEA (non-serious), ABDOMINAL DISTENSION (non-serious) all with onset 27Jun2021, outcome "recovering" and all described as "Late menstrual cycle not due to pregnancy  with extreme bloating and tiredness./ No chance of pregnancy"; FATIGUE (non-serious) with onset 27Jun2021, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of oligomenorrhoea, abdominal distension, fatigue.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.  Follow-up attempts completed. No further information is expected.
to Avoid Future Similar Events (EQUIP: note BEC, serial #)      Pt received vaccination J&J at 12:58pm, within five minutes pt began to complain of itchiness and burning in her throat. Writer offered pt water, pt denied shortness of breath. Pt denied dizziness, no swelling or inflammation noted. Respiratory Rate 18/min. 1:10pm pt continued to complain of "dry and itchy" throat. Writer administered Benadryl 50mg via IM injection to right deltoid. Pt stated the itchiness and burning went away. Continued to monitor patient for thirty mins. Pt stated she felt better.
Patient states that the right arm (site of PNEUMOVAX 23 injection) became red, swollen and painful after injection on 8/30/18. She did not seek treatment and was still experiencing symptoms today 9/5/18.
got a flu shot every year and every year she would be sick at the time two or three times a year; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from Consumer (Patient sister) from via social media.  This case involves an unknown age female patient who got a flu shot every year and every year she would be sick at the time two or three times a year (illness), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, patient received a first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that patient got a flu shot every year and every year she would be sick at the time two or three times a year (Illness).   Reporter reported that, she never get the flu shot, eat healthily and hardly ever get flu, if I do I recuperate swiftly. She had observed other people that got the shot, more apt to get sick.  Details of laboratory data not reported.  Final diagnosis was got a flu shot every year and every year she would be sick at the time two or three times a year.   It was not reported if the patient received a corrective treatment.  The outcome was unknown at the time of reporting.   There will be no information available on the batch number for this case.
FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE). At the time of the report, CONDITION AGGRAVATED (FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE) outcome was unknown.            No concomitant medications were reported.  On an unknown date, the patient experienced flare ups after receiving second dose of Moderna COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of condition aggravated was not provided with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Upon administration in right deltoid, patient felt numbness around arm and underneath and radiates down near wrist. Primarily around injection site. No pain or swelling , just numb.
QUADRACEL was inadvertently given to a patient under the age of 4, and is inquiring if the dose is still valid; Initial information received on 16-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient who was inadvertently given Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] under the age of 4.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine (MMR) and Varicella Zoster vaccine (Varicella vaccine), both for Prophylactic vaccination.  On 16-Mar-2022, the patient received a dose of suspect Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine (with an unknown strength and formulation) (lot number: C5851AA, expiry date: 23-Mar-2023) at a dose of 0.5 mL via intramuscular route in the right thigh for prophylactic immunization.  On 16-MAR-2022 the patient was inadvertently given Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine, under the age of 4 (product use issue) (latency: same day).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown   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.
This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored.  The site and route of VARIVAX administration were not reported.  The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours.  There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 23-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001788:
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 42-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M2(orZ)0A and 011M2(orZ)0A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant since 09-Feb-2021 and Drug allergy (Levofloxacin). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), LORATADINE, SERTRALINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 07-Jan-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 09-Nov-2020 and the estimated date of delivery was 27-Sep-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 04-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.; Sender's Comments: This case concerns a 42-Year-old female with missing obstetric history who received mRNA-1273 while pregnant (vaccine exposure during pregnancy). The patient's  last menstrual period, estimated date of conception and delivery is lacking. Vaccine exposure during pregnancy is assessed as not applicable.
itching; location of the shot got swollen; it is burning; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (location of the shot got swollen) and VACCINATION SITE PAIN (it is burning) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (location of the shot got swollen) and VACCINATION SITE PAIN (it is burning). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (location of the shot got swollen) and VACCINATION SITE PAIN (it is burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.