chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started on Sunday early afternoon with a low-grade fever. By bed time, temp was 104 degrees fahrenheit. Disposition good, eating well, but unable to sleep well. Gave children's ibuprofen every 4-5 hrs, but did not eliminate fever, only reduced to about 101.5. Monday his temperament was very tired, but active, and a reduced appetite. By the evening noticed some bumps/spots on his left buttock. On Tuesday AM, fever was down to about 99-100 degrees F. Spots were now spread to his legs and arms. By Tuesday night his fever was completely gone, and his appetite had fully returned. Bumps were looking like blisters, but some had "depressed" and were flat on the top. By Wed AM, he had more bumps on his arms and a heavy concentration around his feet. As of today, Friday, July 30th, the bumps are still visible, but look less red and inflammed.
Fever of 104.1 rectally. Legs did not want to be moved. Parent's given TYLENOL. On 8-13-10 morning still having fever 101. Pt also had phimosis at time of follow up exam.
Arthritis-like symptoms, 3 weeks post vax, of MMR vaccine. Pain in knees and constant, occasional pain in hips and ankles, rarely in shoulders. Was limping X 2 weeks, only occasionally limps now after 3 weeks. Continues to complain of pain, occasionally.
Numbness and tingling all over body. Continuous Headache above left eye, with no relief from pain meds.
Patient developed redness, swelling, pain and itching exceeding 1-15 index in area of injection.
This spontaneous report was received from a medical assistant referring to a 14 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # US-009507513-1710USA009210 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # US-009507513-1710USA009210 is being deleted from our files and the case is consolidated into case # 1711USA003871 with the correct Aware Date 18-SEP-2017.; Sender's Comments: US-009507513-1708USA011654.
On 7/2/19 patient received PPSV23 at age 63, on 11/19/21 patient received same vaccine at age 65. Patient administered series incorrectly.
I contracted COVID-19 5/1/2022 with symptoms of cough, congestion, headache, body aches, and fatigue. I began taking Paxlovid 5/2/2022 after a telemedicine visit.
A report has been received from a Study Investigator concerning a female subject, Height 68.0 inches, Weight: 135.0 Pounds. A post marketing Safety Study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date. The date of last menstrual period was 24-SEP-2013. The patient experienced pregnancy which was started on 24-SEP-2013. The estimated date of delivery was 23-JUN-2014. The outcome of the pregnancy was reported to be a healthy baby born on 16-JUN-2014. The number of weeks of outcome of pregnancy was 39. The delivery was done by caesarean. The report was considered to be non-serious. The study considered that there was no casual relationship between pregnancy and study therapy.
Shortness of breath, heart palpitations, fatigue, rapid heart rate Irregular periods (after 2.5 years on IUD with no menstruation cycles) Allergic reactions to bug bites (intense swelling and pain) (did not previously have these issues)
rapid onset of symptoms, hands turned different colors, followed rapidly by chills.  went home, over next hours fever spiked high, headache, nausea.  night sweats, cramps, body ache
Patient developed a red, itchy rash around lips that progressed until treatment 30 days post vaccine. The rash continues in patches throughout the body, with pustules. Patient had irritation in the mouth region for months prior to vaccination. Present to pharmacy stating dermatologist believes the cause was the vaccine.
The evening of September 25, 2022, I felt scratchy throat and totally exhausted. I was fatigued with a little bit of sore throat. I fell asleep for hours and woke up will chills and a very bad headache and more fatigue. I decided to call the COVID-19 center, and had a telehealth visit the following morning. I was prescribed PAXLOVID.
This spontaneous report was received from a physician (reported as medical student) refers to a patient of unknown age and gender. On 0-APR-2013 the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). On an unknown date in June 2012 the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). No adverse effect reported. Additional information has been requested.
UNABLE TO WALK AND WAS ON WHEELCHAIR; FELT SMALL TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included tibial plateau fracture surgery, and concurrent conditions included allergic to penicillin, allergic to sulfas, allergy to macrolide, and deep vein thrombosis. The patient experienced allergy when treated with codeine, gliclazide, and diazepam.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included cannabis sativa, celecoxib, gabapentin, and paracetamol.  On 06-MAY-2021, the subject experienced unable to walk and was on wheelchair. On 06-MAY-2021, the subject experienced felt small tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to walk and was on wheelchair, and the outcome of felt small tired was not reported. This report was non-serious.
SWELLING/PAIN LYMPHNODE IN ARMPIT OF LEFT ARM AS WELL AS RIGHT EAR; HEADACHE; FEVER; CHILLS; MUSCLE ACHES; RASH ON LEFT CHEEK ON FACE
The patient reported developing clear "bubbles" at the injection site the day after vaccination. I saw what looked like a popped blister and some redness when the patient returned to the pharmacy one week after injection.
Vaccines administered after freezing temperature storage; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HBV (Engerix B) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's Comments: Vaccine manager reported that, since 18th March 2022, Engerix-B was exposed to a lowest temperature of minus 29.3 degree C for 2 hours and 30 minutes. The reporter stated that, it was possible that some of the affected vaccines had been administered after the freezing temperature exposure, though at this time it was not known for certain. The reporter consented to follow up.
This case was reported by a healthcare professional via sales representative and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema and swelling. The healthcare professional reported that they are seeing more redness and swelling attributed to KINRIX that what they have seen in past. No subject specific information was available. At the time of the report no other details were available. At the time of reporting the outcome of the erythema and swelling was unspecified.
Testing positive for Covid virus, after both vaccines; Testing positive for Covid virus, after both vaccines; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 37 patients. This report is for 25th of 37 reports. A 71-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was not provided) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 02Aug2021. The reporter stated they were monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The reporter at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information. Reporter stated, reclarified later in report, she had 37 patients with partial identifiers, stated she could not provide some identifying details and that she would need to check with her legal department first. Reporter stated that Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. Description of complaint: Reporter was reporting on the Pfizer Covid 19 vaccine, reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. Some identifying details provided. Product strength and count size dispensed: not applicable. The patient underwent lab tests and procedures which included PCR Covid test (Sars-Cov-2 test): positive on 02Aug2021. The outcome of the events was unknown.  Information about lot/ batch number is available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Master case, same reporter/drug/AE, different patients
A non-pruritic macropapular rash appeared on the front of both thighs and back of arms. It then progressed to the rest of the legs and arms. It resolved a week after it started on it's own.
Later in the day maybe 5 to 6 hours after getting the shot I began to uncontrollably shake and got extremely cold for a period of two plus hours. Other things but do not remember exactly and called the doctor as my chest for giving me some problems thought I might be having a heart attack of which he assured me was not the case.
feel tingly & kind of numb; feel tingly & kind of numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received BNT162B2, administered in arm right, administration date 21Apr2021 11:00 (Lot number: EW0169, Expiration date: Unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Discoid lupus erythematosus (Skin lupus, NOT systemic lupus)" (unspecified if ongoing), notes: Discoid lupus erythematosus (Skin, lupus, NOT systemic lupus). Concomitant medication(s) included: SYNTHROID. Past drug history included: Known allergies: sulfa, reaction(s): "drug allergy", notes: Sulfa. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: mRNA/Pfizer, Lot number: ER8733, Lot unknown: False, Administration date: 23Mar2021, Administration time: 11:00am, Vaccine location: Right arm, Dose number: 1), administration date: 23Mar2021, when the patient was 55 years old, for Covid-19 Immunisation, reaction(s): "feel tingly & kind of numb". The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 22Apr2021 11:15, outcome "recovering" and all described as "feel tingly & kind of numb". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
4 days later noticed an area of small blisters that are now flaccid, linear redness, no crusting that you would see in herpes and no dermatomal appearance like in shingles, tender but not itchy
large amount of swelling rt leg, thigh & somewhat below;pt limps no fever, however;
Extreme Fatigue that led to multiple syncope. A police officer thought I had a heart attack and thus I ended up in the hospital. I did not have a heart attack but seemed to have fainted while walking or realizing it.
Information has been received from a nurse concerning a 17 year old female with no medical history or allergies, who on 25 Sept 2006 was vaccinated IM into the left deltoid with a first 0.5ml dose of HPV vaccine (lot 653735/0688F). There was no concomitant medication. Twenty four hours after vaccination, the patient experienced redness and swelling at the injection site and one vesicle was fluid filled and ruptured. Unspecified medical attention was sought. No diagnostic studies were performed. Subsequently, the patient recovered. The nurse stated that the physician will discontinue the therapy and will not be administering any further doses of this vaccine to this patient. No product quality complaint was involved. Additional information has been requested.
Patient referred to clinic for increased bruising. Patient reports heavier menstrual flow, frequent bloody nose recently.
Muscle Soreness; Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th June 2021) for prophylaxis.   On 27th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced muscle soreness and pain in arm. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the muscle soreness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was still having muscle soreness. Not numbness or shooting pain, just periodic muscle soreness. The reporter was consented to follow up. The reporter batch number T19BR, does not exist in sales datasheet was updated as TT9BR as per sales datasheet. This case has been linked with US2019172823 having same reporter.
PT IS UNDERAGE, THE GUIDELINES SAY ANYONE UNER 18 YO SHOULD NOT RECEIVE VACCINE
Headache; Muscle ache; Chills; Joint pain; Injection site pain; Tiredness; Fever as high as 104.8; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the upper right arm on 08Apr2021 at 15:15 (at the age of 46-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the upper right arm on 30Apr2021 at 15:00 (at the age of 46-year-old), both as a single dose for COVID-19 immunisation. Medical history included HPV (human papillomavirus) related to cancer. The patient received other unspecified medications within two weeks of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin and sulfa-based medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, within hours of vaccination, the patient had tiredness. On an unknown date in Apr2021, after 36 hours of vaccination, the patient experienced fever as high as 104.8 unspecified units. On 29Apr2021 at 21:00, the patient experienced injection site pain for five days, headache, muscle ache, chills and joint pain. The clinical outcome of the events injection site pain was recovered on 03May2021. The clinical outcome of the events headache, muscle ache, chills and joint pain, fever as high as 104.8 and tiredness were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Patient was given vaccine that was past 12 hours of viability but less than 18 hours since first puncture.  We called moderna and they directed us to the state.  The state directed back to us as whether to re administer.  Currently we are consulting with our company as to the best course of action.
pt vax hepta B. pt ex fever, vomiting, and soreness at inject site 30 min aft vax. sx remitted spont. no addit. doses.
Pain in the injection site, the left arm, was felt immediately. The arm was sore and inflamed for days, and soon the shoulder pain began. After several weeks I had lost strength and was unable to raise my arm or get dressed or do many other things without great  discomfort. I first sought the advice of a doctor in early December who prescribed a round of steroids. On December 18, 2020, Dr prescribed a higher dose of steroids for a longer duration of time. With no relief, he then prescribed rehabilitative exercises and a muscle relaxer and pain medication.  Next he ordered x-rays of the left shoulder and referred me to an orthopedic specialist.
Received 2nd Moderna vaccine on 4/15/21. Woke up on Saturday 4/17/21 with significant "cramp" in left calf. Pain persisted, so patient went to doctor on 4/19/21. Blood work did not "rule out" clot.  Doctor ordered venous doppler which confirmed clot. Prescribed 3 month course of Xarelto.
This case was reported by a nurse and described the occurrence of injection site cellulitis  in an 18 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  ON 20Feb2004 the pt received the fourth dose of Infanrix. The day after receiving Infanrix, on 21Feb04, the pt experienced injection site cellulitis. The pt was treated with unspecified antibiotic possibly related to vaccination with Infanrix.
2 day duration localized, moderate induration and swelling at injection site;  followed by approx 5 days moderate, generalized body myalgia negatively affecting daily activities.  Associated HA throughout duration of symptoms.
1 hour after vaccine admin pt had stomach cramps and diarrhea and was having difficulty walking. Tenderness in bilateral legs, thighs, knees, and calfs. Pain to touch on thighs and calfs. DC DX: myalgia, improved. Pain enhancement syndrome, improved. Anxiety, stable. Diarrhea, resolved.  PMH: multiple MRSA abscesses.  Presented to ER with C/O constant anterior pelvic pain with inability to walk for about a week. C/O pain on bottom of feet, lets, spinal and neck pain but denies headache, blurred vision, nausea and vomiting. Loose stools for 5 days PTA.
Patient was given .2 of the peds pfizer booster without it first being diluted. This increased the amount the patient was given of the vaccine.
Following a series of 3 vaccines in 8/00. the pt developed bilateral knee pain with effusion.
Patient reports bleeding once the vaccine given, and now a bruise (dark blue in color) about the size of a 50 cent piece has appeared on her arm. Patient reports slight pain, weakness, discomfort.
11/15/2021: Pt was admitted to the hospital due to fatigue and 3 days cough. Symptom onset was 11/12. Tested positive 11/15, 21-days post positive test on 10/6.  11/16: Started on decadron, 10 day course ends 11/24. combivent MDI daily, albuterol MDI PRN. Vitamin D3, zinc, and melatonin started. She was also discharged this day
Date of Admission: 10/26/2022   Date of Discharge: 10/29/2022   Diagnoses on Admission Order: COVID      Hospital Principal Problem (Discharge Diagnoses): COVID
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Delivered live full term baby) on 16-Feb-2015, Pregnancy (Delivered live full term baby) on 23-Feb-2018 and Pregnancy (Delivered live full term baby) on 21-Aug-2019. Concurrent medical conditions included Epilepsy (9th grade) since 1998. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Nutritional supplement, ZINC for Zinc supplementation, VITAMIN D3, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Mar-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2020, Pregnancy test: positive (Positive) Positive.     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.   No treatment information provided.  Estimated date of conception is 29 Jun 2020. Company comment: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.