chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up each morning since 6/28/21 dizzy.  On 6/28, I fell out of bed and hit my head.  On 7/9/21 had dizzy episode getting out of vehicle and drove to clinic.  They advised I go to ER.  Treated for vertigo and advised to have stress test completed and see cardiologist.  Stress test scheduled for 9/2/21.
pt recv vax & pt devel a mild rash consisting of a minimal amount of lesions;
I developed a rash that was red and itchy around feet, legs, back and all over my body. A rash around my right eye that lasted about 1-2 weeks. The rash itself lasted 4 weeks. I had to visit the dermatologist in which ended in me having to have a steroid shot and steroid creams. The doctor performed a shingles test and it was not shingles. The rash has gone away but I do have scars.
Injection administered on 1/4/21 and was given in upper left shoulder joint opposed to the deltoid muscle. I completely removed my shirt to assure proper placement.  Common soreness to shot experienced next two days after administration, however soreness felt in shoulder joint rather than muscle. Pain re-occurred on 1/12/21 and has not been totally relieved despite the usage of anti-inflammatory medication eg. Ibuprofen 400mg,  Tylenol 500mg along with Ibuprofen for soreness. The worst pain I experience is when I go to sleep being prematurely awaken by aching and throbbing to my affected area. Again, not being any discomfort to muscle but rather left shoulder joint pain where sometimes I am discouraged from raising my left arm to my side. It does not bother me so much to raise my left arm towards my front. I have been working through my discomfort while being very careful not to aggravating it further. My concern comes from the fact that it has not completely gone away after the extended time frame and becomes more intense in the evening.
Vaccine breakthrough infection; Tested positive for covid19; loss sense of smell; Loss sense of taste; Lack of drug effect; Sniffles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 266DZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced RHINORRHOEA (Sniffles). On 30-Sep-2021, the patient experienced COVID-19 (Tested positive for covid19), ANOSMIA (loss sense of smell), AGEUSIA (Loss sense of taste) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). On 02-Oct-2021, RHINORRHOEA (Sniffles), ANOSMIA (loss sense of smell) and AGEUSIA (Loss sense of taste) had resolved. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection), COVID-19 (Tested positive for covid19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. It was reported that Patient was near an infected unvaccinated person on 21September2021 and got a breakthrough infection from unvaccinated person.  Patient did not take any medicine before or after the vaccine.  Company comment: A 50-year-old male presented with a serious unexpected event of vaccine breakthrough infection, and non-serious COVID-19, rhinorrhoea, anosmia, ageusia, and drug ineffective. Latency 72 days after first dose and 45 days second dose. Event outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 50-year-old male presented with a serious unexpected event of vaccine breakthrough infection, and non-serious COVID-19, rhinorrhoea, anosmia, ageusia, and drug ineffective. Latency 72 days after first dose and 45 days second dose. Event outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The medical assistant at the site was vaccinating patients. The clinic was held by HR support at  High School at 1. Rocket. The clinician had drawn up 3 vaccinations for those waiting. 2 Moderna boosters and 1 Pfizer booster. All boosters were labelled with the color coded sticker for that vaccine and had the name of the vaccine on each sticker and had the designated card for each patient in the tray. The MA took the next patients tray with her vaccine card and Modrena booster. When the MA called the patient, she stated she wanted another person to go ahead of her because she had an appointment and was in a  rush. This patient wanted the Pfizer booster and the MA did not replace the previous patients tray and grab the correct one. As a result, the MA went through vaccine verification and vaccine history and administered the vaccine without realizing she has the wrong vaccine. Once realized, the MA apologized to the patient, the clinician explained the boosters can be interchangeable but of course the patient was a little upset. The patients card was corrected. Management notified of incident, safety officers and LNO's notified of incident. No adverse events noted post vaccine.
Information has been received from an office manager concerning a 63 year old female with cardiac failure congestive and diabetes and a history of breast cancer and chemotherapy in late 1990's who on 01-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot #658208/0886U). Concomitant therapy included LANOXIN, SYNTHROID, hydrochlorothiazide, losartan potassium (MSD), DIGITEK, simvastatin (MSD) and GLUCOPHAGE. On 04-OCT-2008 the patient developed a zoster rash on her left thorax area. The patient was in pain. The patient was seen in a physician's office and was prescribed VALTREX. The outcome of the patient was not reported. The reporter considered zoster rash on left thorax area and pain to be disabling because "the patient is unable to work until lesions dry up". Additional information has been requested.
Product use at inappropriate site; Movements reduced; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT USE ISSUE (Product use at inappropriate site), PYREXIA (Fever) and HYPOKINESIA (Movements reduced) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported.).   On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced PRODUCT USE ISSUE (Product use at inappropriate site). On an unknown date, the patient experienced PYREXIA (Fever) and HYPOKINESIA (Movements reduced). On 04-Apr-2021, PRODUCT USE ISSUE (Product use at inappropriate site) had resolved. At the time of the report, PYREXIA (Fever) and HYPOKINESIA (Movements reduced) outcome was unknown.            Concomitant medication use was not provided. Treatment information included arm treated with hot showers.. Action taken with mRNA-1273 in response to the event was not applicable.
7MAR96 pt recv vax;19MAR96 mom called pt had rash over body, temp of 102, vomited x 1, some diarrhea on 16MAR & 17MAR
Left deltoid-swelling with redness. Parent advised to given Children's Motrin as needed and also apply an ice pack to deltoid.
I  started getting the chills at 9:30pm followed by one of the worst headaches I've ever had, a fever of 102 i don't recall exact temp but it was over 100, also very bad muscle aches. This lasted until 5pm the next day.
Child received Tdap, MENACTRA and GARDASIL on 2/26/14. Mom noticed redness and swelling on 2/27/14 after playing baseball, some warmness to the touch also.
was diagnosed with shingles; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with shingles. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
Vaccines were given on 12/02/2019. By evening of 12/02/2019; left thigh had two small bumps. skin toned. No bumps on right thigh. By evening of 12/03/2019, upper bump on left thigh became red. On morning of 12/04/2019, left upper bump was red and swollen. Swelling  "bigger then a quarter. " Patient came into office for an appointment on 12/04/2019. Amoxicillin 400mg/5ml 5 ml twice a day for 10 days and Hydrocortisone cream 1% apply to area twice a day for seven days was prescribed. Medicines started evening of 12/04/2019 per Mom. By morning of 12/05/2019; redness was gone. Area was still swollen but swelling was less. Today, 12/09/2019 left upper bump about size of pea. Mom can feel bump but can not see it.
Intensive convulsion; unable to turn torso; severe back pain; musculoskeletal injury; muscle tear of some sort; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient never had any conditions or issues, nor any record of chronic pain or back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number :Unknown and expiry: Unknown) 1 total , administered on APR-2021 for prophylactic vaccination. The Batch no was not reported and has been requested,  No concomitant medications were reported. On APR-2021, the Patient experienced intensive convulsion, unable to turn torso, severe back pain and discharge with musculoskeletal injury. On APR-2021, the Patient experienced muscle tear of some sort.  Laboratory data included: Scan (NR: not provided) No internal Issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intensive convulsion, severe back pain, unable to turn torso, musculoskeletal injury, and muscle tear of some sort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210549341- covid-19 vaccine ad26.cov2.s-Intensive Convulsion-This event is considered Un assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
No side effects other than sore arm for 36 hours. Around 36 hours after vaccine, I developed fatigue, aching body, swollen lymph nodes in my throat - especially on the side where I had the shot - that made my throat sore when swallowing. I had a fever around 100-101 from Sat. 4/24-Mon 4/26, spiking up to 102.6 at the highest point on Sun 4/25 in the AM (3 days post-shot). My fever went away for good the afternoon of Mon 4/26 (4.5 days post-shot). My swollen lymph nodes that caused pain while swallowing took another ~24 hours to resolve (5.5 days post-shot). I rested, lots of fluids, took tylenol and advil, etc. on advice of my PCP.
I had a sore throat. I felt that my temperature may be up a little bit. I had a slight headache and a cough. I took a home COVID-19 test and it registered positive. I contacted my doctors office and got a telehealth appointment and was prescribed Paxlovid and started it two days later.
caller had bloodwork done and platelet count level was down. Can the vaccine cause this?; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 77-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 11:00 (Batch/Lot number: EN6207) at the age of 77 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Time: 14:00, lot: EL9267, Route of administration: right upper arm), administration date: 19Feb2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 03May2021, outcome "unknown", described as "caller had bloodwork done and platelet count level was down. Can the vaccine cause this?". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Initial unsolicited report received from a consumer (patient's mother) on 26-Apr-2018. This case involves a male patient (age was not reported), who was vaccinated with a dose of MENACTRA and HPV VACCINE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 24-Apr-2018 on Tuesday. The patient's medical history and concomitant medications were not reported. On 24-Apr-2018, same day following the vaccination (reported as just after the second vaccine given), the patient started to pass out. It was also reported that the reporter thought the MENACTRA vaccine was given first, but she was not certain about that. Lab data and corrective treatment was not reported. On an unknown date, the patient was recovered/resolved from the event. It was reported that her son was fine now. The healthcare team at the practice indicated that this happens about once a week at their practice. Upon internal review the case was considered as serious because of important medical event: patient started to pass out. Follow up report received from consumer (patient's mother)  on 26-Apr-2018. This case involves 16 years old patient. It was reported that the provider had her son lay down and he felt better and they went home. On 24-Apr-2018 in the evening same day post vaccination patient experienced headache. Patient had not recovered from headache as of 26 Apr 2018 and recovering from other event. List of documents held by sender: none. Sender's Comments: Follow up information received on 26-APR-2018: Patient experienced loss of consciousness and headache after vaccination with MENACTRA and HPV. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
My husband fainted on a return trip from the bathroom @around 2:30 a.m..  And again this a.m. around 5:00 a.m.  Vomited this a.m., mostly mucus.  He is resting/sleeping now and we have made no attempt as yet to contact his physician.
COVID-19 Vaccine Bivalent BOOSTER (MODERNA) use for COVID-19 under Emergency Use Authorization (EUA): Pt presented to retail pharmacy to have covid booster and was given the peds does as opposed to the adult dose. Pt contacted and notified of error
I started to feel a lil pain in my ear. I started to have numbness and dizziness. The left side of my face went numb. I went to the emergency room and they told me I had problems with my brain. They ran a few test on me. I had no headache at first then I started to get a small one.
All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, single (Lot number: EN6201) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9263; Route of Administration: intramuscular; Anatomical location: Left Arm), administration date: 25Jan2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm a little sore". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "not recovered", described as "She has had dizzy spells for over a year". The event "she has had dizzy spells for over a year" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: All her vaccine doses would be given on left side because she is right handed and it made her arm a little sore, so she thought they were all given in left arm. When she first had dizziness, it would last 30 seconds and then it will be gone. The dizzy spells did not go away.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318465 Same patient/vaccine, different dose;
shingles; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program.  A female consumer of unknown age received pneumococcal 13-val conjugated vaccine (dipht crm197 protein) (PREVNAR 13) for immunization many years before the report. Medical history included celiac disease. Concomitant medications were unknown. Consumer stated that she had the original pneumonia shot many years before the report; consumer also stated that she did not want to get the shingles again so she was due to receive a shingles vaccine the day after the report. The outcome of the event was unknown. No follow-up attempts are possible. Information regarding batch/lot number cannot be obtained.
On 5/3/03, three days after being given two inoculations, pt began to show significant signs of acute encephalopathy, with severe weakness, significant decrease in mental status, consciousness, and appetite. She also experienced excessive vaginal bleeding with abdominal cramping and tenderness. On 5/7/03, the symptoms hadn't lessened, so pt was taken to her private physician. PA prescribed Medroxyprogesterine tablets for ten days to stop excessive bleeding. On 5/9/03, pt was taken to the ER because her physical and mental status were becoming severe Dr. discharged pt with instruction to continue the medication, and to follow up with her physician. On 5/14/03, pt went to her follow-up appointment with her physician. The doctor was relieved that the bleeding stopped on 5/13/03, but additional tests were scheduled. Pt returned to school that same week, but began to exhibit signs of mental anguish both at school and at home. On 5/27/03, after school, she attempted to cause harm to herself, and she could not be restrained. From 5/27/03 to 6/25/03, pt remained on suicide observation in the detention center. There, she was prescribed Wellbutrin, and antidepressant. From 6/25/03 to 7/18/03, pt was placed in a youth center where she received counseling services. She was required to remain on the antideprressants for the duration of her stay. When she was released home, she voluntarily discontinued them. I received copies of the notes in September. At that time, I approached Dr and asked him why his notes did not include any mention of the two inoculations pt received, and may have prompted her illness. He stated to me that he could not do so because pt had not received the inoculations at their clinic.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 10-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot # L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored, No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 28Jul2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 which included Paxlovid administration from 04Aug2022 to 09Aug2022. Additional information: Patient has no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness of skin from the pectoral region of the chest on the left, left arm and area around elbow; skin is swollen and tight especially around the elbow.
Chills, dizziness, aches, fever for 2.5 days and then rash.
knocked on her rear end; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (knocked on her rear end) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ADVERSE EVENT (knocked on her rear end) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, ADVERSE EVENT (knocked on her rear end) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Had a headache for 4 days then on the 5th day, 7/23, had a sever headache with vomiting and unconsciousness. A subdural hematoma was diagnosed and had a craniotomy at about 3am on the 24th, then another on the 26th.