chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 Days after shot massage therapist noticed rash on lower back.  No pain but itched.   Continually got worse and small blistering.  9 days after shot diagnosed with shingles.  Never had an outbreak before.   I am convinced it was from the vaccine.  I had mild case of covid Nov. 2020.  I only got shot because my son insisted I needed it before seeing his 6 month old daughter.
-fainted, first limp, then stiff recovered and was fine afterward. (after administration and flu vaccine)
collapse; was awake but couldn't  stand; when was able to stand couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of FALL (collapse), DYSSTASIA (was awake but couldn't  stand) and GAIT DISTURBANCE (when was able to stand couldn't walk) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FALL (collapse), DYSSTASIA (was awake but couldn't  stand) and GAIT DISTURBANCE (when was able to stand couldn't walk). At the time of the report, FALL (collapse), DYSSTASIA (was awake but couldn't  stand) and GAIT DISTURBANCE (when was able to stand couldn't walk) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Patient reported that she had the events again on the 01-Apr-2021, and fell for two days.   This case was linked to MOD-2021-417742 (Patient Link).
Information has been received from a health care professional concerning a pt who in 9/99 and 10/99 was vaccinated with the first and second dose of varicella. In 2/00 a titer was found to be negative. Additional information has been requested.
Developed dermatographia her skin itches and has raised welts.; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Developed dermatographia her skin itches and has raised welts.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 048B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-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 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced MECHANICAL URTICARIA (Developed dermatographia her skin itches and has raised welts.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Developed dermatographia her skin itches and has raised welts.) outcome was unknown. No concomitant medications were reported.  The patient had received the first, second and booster dose in her left arm shoulder deltoid muscle. Patient did not experience any adverse with primary series of vaccination. Patient has not seen a doctor for the condition. Patient mentioned regarding a group where other patients reports dermatographia and urticaria after receiving the Moderna Covid-19 vaccine booster dose.
Pt reported muscle spasm in left upper arm, neck and then back muscle spasms on r side of neck as well, but worse on left. Shooting pain radiating fromleft shoulder to vase of skull.
a 2 month 15 day old child got Quadracel/No AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two month 15 days old patient who received a vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot number and expiry date were not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to product administered to patient of inappropriate age.  At the time of report no adverse event was reported.  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.  Information on the batch number was requested.
Positive COVID-19 pcr test; Positive COVID-19 pcr test; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05Feb2021 (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: IMMUNISATION (medically significant) with onset 27Sep2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Positive COVID-19 pcr test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: positive COVID19 pcr test.  The lot number for bnt162b2 was not provided and will be requested during follow up.
high pitched cry 3-4hrs in the evening of 12SEP95;t102 no szs, constant cry nothing would comfort the baby;gave APAP w/no relief
swelling at the injection site; heat at the injection site; pain at the injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site pain and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain and injection site erythema to be related to Shingrix.     Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment: This case was self reported by the patient. The patient received the first dose of Shingrix. The patient was experiencing redness, heat, swelling and pain at the injection site. The adverse events was filed.  The reporter did not consent to follow up.
Occurred 5 days after the shot. Is this a case of a true outbreak of chicken pox and transmitted to other family members? THis 2 1/2 year old-severe case; 4 mo. old-BF infant-15 pox. Tx'd family with Zovirax 200mg/sec x 5 days.
There was a smallpox scare.  Our family searched for a vaccine.  A private doctor administered it.  Child became feverish and had a very high fever for over a week.  She was a bright 4-year old before the vaccine.  She became mentally retarded after the fever.
14NOV95 red blotches developing on body,itching,face began to swell;15NOV95 redness of face,arms;eyes blood shot;DPH given;saw PMD who prescribed DPH x 72hrs;16NOV95 diff concentrating;17NOV95 swelling & redness disappearing-better
Information has been received from company representative concerning his 12-month-old daughter with no pertinent medical history or allergies, who "2 days", on approximately 13-JUN-2006 was vaccinated with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 650941/0972R).  Concomitant vaccinations included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PRENAR) and varicella virus vaccine live (MSD). "This morning", on 15-JUN-2006, she "broke out with hives all over" and had a "skin sensitivity reaction". Unspecified medical attention was sought. It was reported that the reaction was not chicken pox. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Info has been received from a physician concerning her 6 year old son with no pre-existing allergies or medical conditions, who in at approximately 2 years of age (approximately September, 1999), was vaccinated with a dose of varicella virus vaccine live. The pt was not ill at the time of his vaccination. In June, 2004 (exact date not specified), the pt developed varicella disease, which was described as a mild case of breakthrough varicella with approximately 40-50 lesions (also previously reported as 25 lesions). The reporter also noted that her son had a low-grade fever. It was reported that there was an "outbreak" at his school. He recovered in approximately 10 days. There were no diagnostic or lab tests performed. No additional info is expected.
This initial spontaneous case, was received from other health professional on 10-Nov-2017, concerning a 59-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 10-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195129 and expiry date: 01-May-2018). It was reported that, the patient received 2 flu shots in a row, 1st on 09-Nov-2017 (but was not sure) and 2nd on 10-Nov-2017 and no adverse event was reported after the vaccination. The reporter assessed the event as non-serious.
Approximately 0900, patient called to state she had hives on arms and legs. No respiratory symptoms. Patient saw her personal physician who treated her with steroids. Spoke with patient at 0930 11/15/13 - hives gone itching continued.
Patient hospitalized for a carotid aneurysm within 6 weeks of receiving COVID vaccination.
Had lower blood pressure since day 6.  No treatment.  dizziness some times. PS: day 1: blood pressure was <120/<80,  day 6 to present: blood preesure was 89-112/60-81 PS: blood pressure monitor: Omron (model# BP7100) from pharmacy
Pt states that next day after vaccine, his back has large rash patch that is red between his shoulder blades.  Wife describes it burn-like.
Temperature 24 hours later of 99-101 for 2-3 days following injection.  Patient never reported reactions until she came in for 2nd injection.  Doctor would not authorize 2nd vaccine.
Before 2nd dose screening reported throat tightness lasting 1-2 hours after dose 1. Possibly anxiety/OCD symptom per patient. Dose 2 not given.
Left upper arm 2 x 4 cm indurated, erythematous patch, slight tender to palpation, no limitation of arm movement.
I was having what I thought was a sinus infection with postnasal drip, the sinus headache, maybe even a migraine, I was fatigued and overall, just felt miserable. I ended up doing a telehealth appointment on December 13th because I was not doing better. They gave me a treatment of Prednisone and a Zpack and at first that was working but that did not end up clearing anything up. When I was almost done with the medication, I was a little better but then I got worse and at this point I ended up going to the ER on Monday the 19th. They ended up doing Bloodwork and gave me medication for the Migraine and gave me IV Fluids as I could not keep anything down. My blood work showed that I had an infection, so they did a CAT Scan to see if there was anything going on with my sinus and then also, they did a Spinal Tap to rule out meningitis. They gave me a medication and I have gotten a little better and while I am not having bad migraines, I am still having headaches. They also advised that I take magnesium to help with the migraines. I will note that I did a flu shot on the same day that I got my COVID-19 Bivalent vaccine. I have also had COVID-19 in June of 2022 after being vaccinated as well and while I am unsure if the health problems could be related to that I have noticed since getting the COVID-19 Bivalent dose things have gotten worse.
This spontaneous report as received from a nurse refers to a patient with unknown age and gender. For many years, since high school, the patient had suffered with constipation and abdominal "issues", which she had gone to many doctors for (2 primary care docs and 2 GI (gastrointestinal) specialists, and had a colonoscopy), to no avail. It was reported that the patient had been in a old study that's been closed for about 10 years and was vaccinated with GARDASIL (dose, route , lot # were not reported) or placebo on an unspecified date. The patient discovered she had Hashimoto's in March 2013. She was diagnosed with hypothyroidism at age 23 and have been on SYNTHROID. In the last couple years these GI problems had become more uncomfortable, including heartburn, nausea, and gas after eating anything. These symptoms interfered with the patient's well-being, sex life/relationship, travel, daily activities, social life, etc. Since conventional medicine and approaches have not helped with the patient's stomach, the patient went to see a Naturopath. The Naturopath advised the patient went on the GAPS diet, which was a ketogenic diet. The patient had been on this diet for about 6 week. A lot of her GI problems have improved, which was good. But, the patient felt like crap from not getting enough carbohydrate. The patient had chronic headaches, weakness. The Naturopath says this was due to a "die-off reaction" from the "bad bacteria" dying. The Naturopath upped the dose of SYNTHROID once discovering the patient had Hashimoto's and that the patient was still hypothyroid. She took the patient from the 75 mcg the patient had been on for years all the way up to 125 mcg on approximately 19-MAR-2013. After 6 weeks on this higher dose, the patient had blood drawn Tuesday, on 30-APR-2013, and was now hyperthyroid, with a TSH (thyroid stimulating hormone) of 0.5. The patient had been having a lot of anxiety the past 2 weeks, from approximately 19-APR-2013 and she thought she was going nuts. At the time of reporting, the patient's outcome was unknown. This is one of several cases with the same reporter. Additional information has been requested.
Pt received Janssen vaccine at approx 1040.  Within five minutes she began to experience a racing pulse, and c/o a "hot neck."  She was taken to a treatment room and a provider was notified.   1049 diphenhydramine 50mg IM given 1053 c/o swollen lips, dry mouth, blurred vision, possible swollen tongue 1109 epinephrine 0.3mg IM given 1111 c/o throat dry, difficulty swallowing 1116 NS 0.9% bolus started 1121 pt reports feeling "much better.  Denies swollen lips/tongue, denies difficulty swallowing, states her vision is clearer 1202 c/o "hot neck and face," dry mouth and difficulty swallowing 1208 epinephrine 0.5mg IM given 1211 diphenhydramine 12.5mg IVP given 1212 c/o chest pain 1225 EKG done 1239 taken via stretcher to ED
Client received first dose of COVID vaccine @ 10:00 am.  Complained of dizziness @ 10:05 am.  Placed in zero-gravity chair and given water to drink.  At 10:10am client reports less dizziness, vital signs stable.  At 10:17 am client reports not dizzy anymore but pain in arm where received vaccine.  At 10:30 am client reports no longer dizzy, sore arm where vaccinated, vital signs stable.  Client left observation area @ 10:40am with family, walking with steady gait.
DID NOT SKIP A DAY BETWEEN SECOND AND THIRD DOSE; This spontaneous case report (PVX2019-2801) was received from a nurse on 13-Nov-2019. It described a male consumer who "did not skip a day between second and third dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer started Vivotif on 08-Nov-2019. He took his second dose according to schedule on 10-Nov-2019 but took the third dose on 11-Nov-2019. The nurse reported that the consumer was in his 40's age.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown. . Company Comment: It was reported that a patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). The causality of the event is assessed as not related to Vivotif.; Sender's Comments: It was reported that a patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). The causality of the event is assessed as not related to Vivotif.
Pt felt nausea, soreness in right arm and later had swelling in right arm, was taken to ER and told to use warm compresses.
Pt was in clinic for office visit and based on the electronic health record it showed that patient was due for a CVID booster. Pt was asked by rooming staff if he wanted booster. Pt and mom agreed to have booster. Pt mom did not have vaccine card with. Clinical support staff went to verify/reconcile patient's records and it did not show he had one.  Pt was given booster injection. When clinical support staff entered the vaccine in electronic medical record it reconciled with the database and showed patient had already had a covid booster on 1/29/2022. Patient/mom and clinician were notified about the error of giving 2nd booster.
This spontaneous report as received from a 75 years old male patient regarding himself. The patients current conditions included cold sores on his mouth (which occurred every 3 months before vaccination) and allergy to NAPROXEN (reported as Neproxine). The patients medical history included precancerous skin growth. On 28-SEP-2011, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671453/1057AA, expiry date was 05-OCT-2012 and dose was not reported) subcutaneously. No concomitant medications were reported. The patient went on to stated that the cold sores on his mouth appear now about every month since an unknown date in September 2011. No laboratory test was performed. The patient sought no medical attention and was treated with VALACICLOVIR HCL (reported as Valacyclvir). The outcome of the event was unknown. Additional information has been requested.
(9/23) - sore arm, headache, joint pain in knees, strong increase in nerve pain leg/feet (has a pre-existing condition with nerve type disorder, under a doctor's care). (9/24) - same, but with pain in back as well. (9/25) through the present - continued strong nerve pain in legs and feet, and arthralgia back and neck. Saw physician for a routine appointment, that was scheduled several months ago, on 9/27/10.
Breakthrough COVID-19 infection. Pt received Pfizer on 4/3/21 and 4/24/21
Metallic taste in mouth. Today is been 24 hrs since vaccination and it comes and goes constantly.
she has ran a low grade fever (99.4) off and on since she got her shots a week ago.  No other symptoms except for a couple of spots that appeared on her shoulder that went away a couple of hours later.  Spots were not raised and she really wouldn't consider them a rash.  She is a little skeptical of vaccines since her grandfather passed away after receiving his covid vaccine.  She is just concerned that the fever has lasted so long and wanted to know if this is normal? She is just not acting herself and is getting more fussy.   Seems a little better today, still has tenderness around injection site.  Times that she is just inconsolable and walks around crying.  Doesn't think that she should get another MMR.
Headache, Myalgia, FATIGUE, LEFT ARM NUMB Narrative:
a patient received a dose of expired ActHIB due to a provider oversight, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 months old female patient who received a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (Lot: UI908AAA, expiry date: 14-Sep-2019) via intramuscular in the left leg on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation on 24-Sep-2019.  It was an actual medication error due to expired vaccine used. Apatient received a dose of expired ActHIB due to a provider oversight.  It was reported that the state regulatory body and caregiver have been informed.   At the time of report no adverse event was reported.  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.
Apparent cellulitis with systemic complaint, red, swollen, warm, feverish. Treating w/antibiotics.
Information has been received from a nurse concerning a patient who was vaccinated with a dose of GARDASIL and may have an unspecified reaction to GARDASIL.  At the time of reporting the outcome was unknown.  Follow up information was received from the nurse concerning the 20 years old female patient who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL.  On 10-SEP-2008 the patient was vaccinated with the second dose of GARDASIL.  The patient experienced hair loss in October, 2008, after receiving the second dose of HPV.  On 03-JAN-2009 the patient was vaccinated with the third dose of GARDASIL.  Additional information has been requested.
Rotarix (do not reconstitute) was mixed as a diluent with the Rotarix powder (reconstitution required) and patient received a double dose.