chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4"x1" area of induration with small vesicles. Area was on outer thigh, Varicella vaccine only given in that leg.
received both doses of the vaccine and ended up with Covid, and was in the hospital for 8 weeks almost dying; received both doses of the vaccine and ended up with Covid, and was in the hospital for 8 weeks almost dying; This is a spontaneous report, received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose 2, single and via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses of the vaccine and ended up with COVID, and was in the hospital for 8 weeks almost dying on an unspecified date. The patient was hospitalized for the events for 56 days (reported as 8 weeks). The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
patient developed SVT and palpitations 9/2021, arthralgia/elevated inflammatory markers 12/2021, atrial flutter 2/2022
On January 25, 2021, I woke up in the morning with a a rash. The rash was red, itchy with slight raised bumps. It was on the front and back of my torso including shoulders in big splotches and on my arms and legs. I used OTC Bendery gel and hydrocortisone lotion to ease the symptoms. I went to my doctor on January 27 and she prescribed a tapered steroid. The rash had eased by the time I saw my doctor. I have never had a rash like this before.
Tinnitus symptoms have been amplified, louder and all the time now.  I did have it ever so often before, but now I always have the ringing in my ears and it's louder.  I've seen an ENT for it and there is nothing they can do about it.
Patient noticed increasing symptoms of bilateral lower extremity weakness approximately 1 week following vaccine. Slowly improved over the course of almost a year, but still with residual right lower extremity myalgias and weakness. Patient did not seek medical care at that time.
This spontaneous report as received from a pharmacist refers to patient of unknown age and gender. On 20-FEB-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot # K000329, exp. date: 06-MAR-2015) (strength and route not reported). The ZOSTAVAX was exposed to 12 Celsius degree for 14 hours. No adverse effect was reported. Additional information has been requested.
I began to feel light headed two days after receiving my second dose. The feeling has continued to this time; not bad enough to see the doctor but is beginning to be worrisome since it hasn't diminished. Other than a sore arm for a day or so, no other problem with either dose. First dose was on 3/06/21, Lot EN6205.
Positive ANA  Whole body pain and inflammation Joint and muscle pain Fatigue No taste no smell, still over a year later
*Note: resident exhibiting cough 9/20/04. 10/7/04 choking and cough with food. 10/14/04 flu vaccine given. 10/20/04 worst cough and lung congestion. Blood oxygen 80-85% O2 at 26. 10/21/04 97.4, 60, 20, 150/80. Blood oxygen 92% with O2. 10/21/04 Hospice ordered. 10/22/04 99, 80, 28, 130/70; O2 saturation 90% with 3LO2. Unresponsive (1100). 10/23/04 0535 expired. Death Certificate received on 11/16/2004 states cause of death is COPD and end-stage dementia. 11/2/04 Nurses notes & med list from nursing home received.  Patient also had history of nicotine addition, dementia, emphysema and seizure disorder.
sore arm; patient received Prevnar subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "patient received Prevnar subcutaneously". Additional information: His wife had a sore arm for about a day after her pneumococcal pneumonia vaccine, but was unsure which brand she received. Pfizer Product Name: Prevnar. The reporter considered event as caused by suspect product.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300080379 Same reporter/patient, different drug/AE;
Seizure. He was stiff, shaking uncontrollably, gasping for air. Seizure lasted 2-3 minutes. Rescue was called to the house. Had to be taken to ER. ER conducted CBC test. Results came back normal. Was prescribed as needed Valium suppository bc this was his first seizure ever
Patient called with c/o tingling sensation above right AC area.  Denies any associated pain, swelling, fever, SOB, itching.  Tingling started about 1 wk post administration of vaccines.   Advised to f/u with PCP with any worsening or non-resolution of tingling within the next few days.  Advised to apply warm compresses to the area as needed and avoid cold compresses.
Breakthrough case admission after 3 vaccines Moderna 2/13/21 lot# 006M20A;  Moderna 3/13/21 lot# 040A21A;  Moderna 12/4/21 lot# 004F21A
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fever, general body pain and chills. On an unknown date, the outcome of the influenza-like symptoms, headache, fever, general body pain and chills were recovered/resolved. The reporter considered the influenza-like symptoms, headache, fever, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient noted that she experienced side effects with 1st dose of SHINGRIX vaccine. The patient said that after the SHINGRIX vaccine injection she had flu like symptoms. With the 1st dose, she had chills, fever, headache and body ache. The symptoms started within 48 hours of the injection and then they resolved the next day. This case was linked with US2018GSK085204, reported for 2nd dose of SHINGRIX for same patient.
fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 46-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in May 2023.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 29-Sep-2023, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) was resolving.            No concomitant drug was reported.  The patient did not experience any additional symptoms/events.  No treatment drug was reported.
CLT SCREAMED ALL DAY RIGHT AFTER SHE RECIEVED THE IMZ. RUN 103 TEMP THE FIRST DAY AND 101 TEMP THE NEXT TWO DAYS. CLT C/O L SIDE OF FACE HURTING AND HURT TO LEFT ARMS. LEFT INJECTION SITE LOOK LIKE BEE STING. DR. WAS CALLED AND WAS TOLD TO GIVE TYLENOL AND MORTIN. FAMILY HX OF PERTUSSIS REACTION.
diagnosed with vertigo by HCP; he couldn't walk he felt that he didn't have his balance; issues of not being able to walk; felt that he had a mini stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (diagnosed with vertigo by HCP), BALANCE DISORDER (he couldn't walk he felt that he didn't have his balance), GAIT INABILITY (issues of not being able to walk) and FEELING ABNORMAL (felt that he had a mini stroke) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced BALANCE DISORDER (he couldn't walk he felt that he didn't have his balance), GAIT INABILITY (issues of not being able to walk) and FEELING ABNORMAL (felt that he had a mini stroke). On 16-Mar-2021, the patient experienced VERTIGO (diagnosed with vertigo by HCP). At the time of the report, VERTIGO (diagnosed with vertigo by HCP), BALANCE DISORDER (he couldn't walk he felt that he didn't have his balance), GAIT INABILITY (issues of not being able to walk) and FEELING ABNORMAL (felt that he had a mini stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that his doctor diagnosed him with vertigo on 16mar2021 and the stroke was ruled out. Patient states that he has taken aspirin. Patient did not self-treat after the first dose.   This case was linked to MOD-2021-083659 (Patient Link).
Patient received a diagnosis of Shingles following vaccination. Patient has 9 shingles lesions located on his right  thigh.
HPV vaccine for bilateral hands warts;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 46 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, candida albicans and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for bilateral hands warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   The patient's immune status was reported as none. The patient was followed up for treatment for 6 months. There was no resolution of patient's condition.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
Positive Covid results; A spontaneous report was received from a health care travel agency employee, concerning a patient who was participating in the mRNA-1273 Emergency Use Program and experienced the event positive Covid results.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 29 Dec 2020.   The reporter stated that the patient had received the Covid vaccine on 29 Dec 2020. On 30 Dec 2020, the patient received positive Covid results. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, positive Covid results, was considered not resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided.  The patient experienced an unexpected event of positive COVID test 2 days after the first dose of mRNA-1273 was administered. Very limited information regarding this event has been provided at this time.  Further information has been requested. The event is assessed as unlikely related to mRNA-1273.
First and Second Dose: Soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single and administration date 24Feb2021 (Batch/Lot number: unknown) 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: PAIN (non-serious), outcome "recovered", described as "First and Second Dose: Soreness".  Additional information: The AE required Physician Office. Additional vaccines administered on same date of the Pfizer suspect and prior vaccinations (within 4 weeks) were none.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Shots were performed at Clinic, Had the 1st shot on 7/26/2021 had alot of fatigue, sore arm and felt very feverish for 2 days started having some itching on my back however  the following week andwhen I looked at back in the mirror I had two spots that looked like misquito bites so just let it go Had 2nd shot on 8/16/2021 within a couple hours my arm had a baseball size, red, raised, warm circle below the shot about 1/2 inch. Within about 4 hours, itching on back worsened and a rash developed on the left side of my back and under my left breast and around my chest cavity. That night I had trouble sleeping and my breathing became short. The next day 8/17 the rash seemed to be spreading and the breathing especially while laying down worsened. I finally could not stand the pain that was developing and the breathing had me concerned I went into the ER on 8/18 about 9am. Chest xrays were done, pulmonary embolism test was performed as well as an EKG. They couldn't find anything wrong. (the Dr listed on my paper work must have been physician on call because a woman didn't get her name was the one ordering tests etc...) they briefly looked at my rashes and sent me on my way and said use benadryl cream. The following day I ended up at Doctors office and was diagnosed with Shingles.
Patient suffers from many allergies so we counseled patient prior to administering vaccine.  Upon questioning she said she had had all 3 pfizer vaccines at our location and had experienced hives later that evening, however her physician still insisted patient receive 4th dose.  She had chlortrimeton and epipen on hand in case of reaction.  About 20 minutes after receiving vaccine she started to feel like her tongue was swelling.  We immediately contacted EMT and I sat with patient to monitor breathing.  Patient on her own took chlortrimeton and had epipen out and ready.  Patient had labored breathing but she was aware, conscious, and speaking the entire time.  EMT arrived and checked her vitals and took her to hospital to monitor her further.
Chills; severe fatigue; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (severe fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (severe fatigue). At the time of the report, MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Laboratory details were not reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
lt upper thigh very swollen from knee to hip pt very irritable & cried inconsolably for 4 hrs; t103;
Started not feeling well about 6 PM.  By 8:00 PM I went to bed not feeling well.  By 12:00 midnight I had a fever of 103 with chills and severe muscle aches on about every joint I had.  By the next day I was feeling better but still had slight temperature.  By Friday I was fine.  Called hospital ER and was told to give 2 more ibuprofen and if temp didnt come down then to go in.  The temp went down to 102.6. I stayed home.
Rash on right side of face, fever 102 and chills, muscle aches, pounding headache, loss of appetite
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 02Apr2021 as dose 2, single (Lot number: EWO150), in left arm, on 14Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FK9093) at the age of 61 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications (reported as patient received other medications in two weeks of starting COVID-19 treatment). Past drug history included: Codeine, reaction(s): "Allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative again; (24May2022) Negative, notes: Tested negative on 24May2022; (29May2022) Positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included COVID 19 Treatment started on 29Apr2022 and stopped on 04May2022. Clinical course was reported as, Ended Paxlovid 23May2022, tested negative on 24May2022. 5 days after last dose of Paxlovid - horrible headache. Tested negative again. 28May2022 very tired, 29May2022, Sore throat and low-grade fever. Tested positive. Feels like a sinus infection, lots of drainage on 27May2022. No treatment received for symptoms and patient was not recovered from symptoms.  No follow-up attempts are possible. No further information is expected.
Left arm never recovered from shot...was placed too high on the arm and caused bursitis. Arm remained weak and injection location muscle very sore, and I couldn't raise arm out to the side without pain. I used ice and tried to rest the arm for over 2 mo. and finally saw my general practitioner for an x-ray and he referred me to Ortho. Dr.
Bloody diarrhea with vomiting. Hospitalized. Dx: Intussusception.
Per medical records, patient has an underlying history of hypothyroidism, oropharyngeal cancer post chemotherapy who presented to the ER on 08/22/2021 with altered mental status and shortness of breath. Pt is also a former smoker. Pt was intubated in the ED on 08/22. Pt expired on 09/05/2021.
After patient received vaccine she had a rash and raised area around the injection site on 1/28/2021. Patient continued to have this and then on 2/17/2021 patient went to the ER with stroke like symptoms ie facial dropping , left sided weakness and slurred speech
Immediately after administering dose 2 of the Pfizer COVID vaccine, patient fainted in his chair (did not fall off chair, stayed seated with head tilted back). Patient had some slight jerking movements and loss of consciousness for approximately 3-5 seconds. Patient quickly regained consciousness and was confused for approximately 5 seconds but then realized where he was and was responsive to questions. Patient stayed seated with head between legs for 15 minutes, then started feeling nauseous and began to vomit. EMS/911 was called to evaluate patient. Patient felt good and was cleared to leave.
Soreness and tingling in fingers on left arm first day and night. 6 days later heart palpitations, fluctuating blood pressure, fatigue, nausea and strange feeling in fingers of both hands. Went to doctors office and ER twice mostly because of the unusually high blood pressure but after EKG's and many other tests showed nothing - prescribed blood pressure medicine on the second ER visit. Heart rate and blood pressure would randomly jump up and down for no reason - spend most of the time in bed and I am a normally very active person with very low pulse and blood pressure. Went to get an Echocardiogram and Holder Monitor today - started to feel a little better but still very limited in physical activity.
2 hrs later stiffness; mom said did not want to stand sat in chair all day 27NOV91; ran fever for 2 wks up to 104; 9DEC91 went to ER; rash some vomiting; rash lasted for 3 wks; mom said was told @ ER that rash was from MMR;
Joint pain; swollen hand, can't close hand, can't grip; swollen hand, can't close hand, can't grip; Slightly swollen middle finger; This is a spontaneous report from a contactable consumer (Patient).     A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:30 as single dose for covid-19 immunisation. Medical history included Type 2 Diabetes and high cholesterol. Concomitant medication(s) included Metformin, Atorvastatin and Vitamin D. The patient experienced joint pain, swollen hand, can't close right hand, can't grip. Patient did not have covid prior vaccination and not tested for covid post vaccination. Patient did not have known allergies. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.