chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker and refers to a 20 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-JUL-2015, the patient was vaccinated with improperly stored doses of M-M-R II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (Merck) (lot # J009987, expiration date 12-AUG-2015, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
I had sore in arm.  About six months later I had a heart attack.  I went to the ER.  They did an EKG.  I had to have surgery, they put a stent in my heart.   They did blood work and urine sample.  I was in ICU for 2 days.   I also felt fatigue as well.
Pregnant and want to be apart of pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and want to be apart of pregnancy registry) in a female patient of an unknown age (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (3 Live full time births). Concurrent medical conditions included Eclampsia, antepartum and Heartburn. Concomitant products included OMEPRAZOLE for Heartburn, ACETYLSALICYLIC ACID (ASPIRIN 81) for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and want to be apart of pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and want to be apart of pregnancy registry) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Glucose tolerance test normal: normal (normal) Normal.     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.   Treatment medications were not reported.
Client came down with chicken pox origin unk. Client is responding well to treatment. Illness has taken its course and client is healing.
12.50 IZ given. 12:53 - L leg red - thigh to feet, hives - red macular rash - some swelling and bruising at injection site crying - Dr. in room cool cloth, BENADRYL and TYLENOL administered at 13:04. 13:45 Sleeping - site improved, less redness. 13:10 mild redness LLE and hives almost disappeared.
At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip.  As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse.  Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe
This is a spontaneous report from a contactable pharmacist.  This report was received Pfizer via a sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain at the injection site. The clinical outcome of the pain at the injection site was recovered. The batch/lot numbers for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), were not provided and will be requested during follow up.
Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # K008931, expiration date 04-MAR-2017) (dose and route were not reported) by an unspecified physician. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore right arm after the injection.  At night had a fever of 100.7 with shaking.  Had fever next day.  Two days post injection had red rash around injection site on right arm that was sensitive to touch.  Patient called ER and was advised to call clinic to report reaction.  Patient reported 6 days post injection and patient no longer had symptoms.  No further treatment needed.
tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-helath care professional via Medical Information Team. An 89-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunization. Medical history included knee issues. The patient's concomitant medications were not reported. On 13Feb2021, patient tested positive for COVID using the rapid test and a PCR. Reporter was not sure whether the patient was exposed to COVID before or after the first dose. On 13Feb2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Patient's second dose was due on 02Mar2021 and the reporter wanted to know if patient should continue with her second dose after she has recovered. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Received 4 month immunizations that day, in the evening became fussy, mom took rectal temp at 10:00 PM and had temp of 105 rectally, pediatrician on call advised to go to ED for evaluation.
Hive-like rash on torso and arms. Also puffy eyes. Given BENADRYL by mother. No rash by the next morning.
10:10am Pt received 1st dose COVID-19 vaccine (Moderna). She was moved to observation where she began reporting waves of dizziness, chest tightness, and scratchy throat at approximately 10:25am. VS taken by EMS on site: BP 175/105, HR 85, SpO2 100% on room air, NSR w/ PVC's on monitor; VS repeated at 10:27am: BP 166/110, HR 91, SpO2 100% on room air, NSR w/ frequent PVCs. Pt continued to complain of dizziness, scratchy throat, and chest tightness. 10:34am pt reported feeling worse, started to feel nauseous. 10:36am VS: BP 169/109, HR 122, SpO2 100% on room air, NSR tachycardic w/ PVCs on monitor. EMS transfer initiated. Pt in ambulance at 10:40am.
within 10 minutes I started to sweat and my Blood Pressure went up. I stayed half and hour. I went home fine and then around 4:30-4:45 I woke from a nap and I had a rash that was itchy across my chest on the right side and it lasted an hour and then went away.
Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face? chin area. Within 39 minutes, left side of face was numb with tingling sensation and lips were fully numb and tingly. Tongue felt swollen and itchy, as well.  Symptoms lasted several hours.  It is now more than a week later and there is still slight numbness in lips and on left side of face. No visible changes have been noticed, just the sensation of numbness as of given Novocain at the dentist.
Chronic Headaches/migraines everyday sometimes debilitating.  Never had headaches.
patient was given a flue shot after we talked about benefits of getting a flu shot. afterward she said she had one (flu shot) for the season and wanted a pneumonia shot.
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "PCOD" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, for Immunization, reaction(s): "Known allergies: Flu shot"; Allergy shot, for Immunization, reaction(s): "Known allergies: allergy shot". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (24Aug2022) Positive, notes: Tested positive for covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient received Paxlovid for treatment of COVID-19 on 11Aug2022 and stopped on 16Aug2022. The patient was tested positive for covid again on 24Aug2022. Brain fog started on 22Aug2022 and tiredness with some breathing impairment had continued. Adverse event start date: 22Aug2022. If vaccine received: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One week after the shot, swelling in left knee and thigh but went away in two days. Two weeks after the shot, swelling behind left knee and calf.
Intense vibration or fluttering sound in my right ear. It felt like my ear drum was throbbing.   Started two days after my second shot. I already has a form of tinnitus prior to the shot. But the intensity and the sound was different and severe.   Visited Dr 3/1/2021 - examined my ear and removed wax. No improvement Visited ENT doctor.  Removed ear overgrowth on right ear. No improvement Dr gave me some tinnitus supplements., Synapse XT. They seemed to help. Some but did not take,away the fluttering completely.  Visited Dr.    Symptoms are better but not gone. My ear still has a fluttering/throbbing sensation.  This is completely different from the tinnitus sounds I was experiencing before the vaccination
Pt had a 30 second tonic/clonic seizure.  CBC, CP, referral to Neurologist.
n/a - a 10ml single dose vial of saline was used for 2 vials of covid vaccine
Initially tongue went numb the swelled slightly; Initially tongue went numb the swelled slightly; My left arm also swelled with lots of pain, then it moved to my back, shoulders, and neck with lots of stiffness as well / my hands swelled, turned red, and felt like they were on fire; extreme fatigue; my hands swelled, turned red, and felt like they were on fire; my hands swelled, turned red, and felt like they were on fire; my hands were numb; My left arm still has a knot in it; then it moved to back, shoulders and neck with lots of stiffness as well; This is a spontaneous report from a contactable consumer. This 39-year-old female consumer (patient) reported that:  A 39-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 17Apr2021 at 13:15 (at the  age of 39-years-old) as dose 1, single for COVID-19 immunization. Patient known allergies: Bees, Mushroom, Zyrtec, and Environmental. Patient medical history includes diabetic and mixed connective tissues disease. The patient's concomitant medications were not reported. The patient other medications within 2 weeks of vaccination: yes too many to list here. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 17Apr2021 at 13:30 patient initially tongue went numb the swelled slightly, able to control with a dose of Benadryl. Patient left arm also swelled with lots of pain, then it moved to back, shoulders and neck with lots of stiffness as well. Later extreme fatigue hit through the following day. Then patient hands swelled, turned red, and felt like they were on fire. All medical facilities were closed so patient took another dose of Benadryl. Patient woke up slightly after taking, hands were numb, then ok when patient woke up from the Benadryl. Left arm still has a knot in it and hurts but patient using it. Patient received treatment for AE (Benedryl at home and from recommendation of nurse). The clinical outcome of the events was recovered with lasting effects/ Recovered with Sequel.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
I started getting a frequent urgency to urinate with a burning sensation and pain. I was negative for having a UTI at my doctors office. It did approve slowly over the course of 2 months. It has become more normal now. In December 2021 and February 2022, I had an abnormal mensural cycle that was longer than normal. In March 2022, I had abnormal mensural cycle that was shorter than normal. I had PMS symptoms about that whole month. I also experienced tenderness in my breast.
Patient reported a menstrual changes. Pt's last regular period was 7/11/21, vaccine on 7/31, light bleeding 8/10, regular heavy bleeding 8/21 x3-4 days, light bleeding 9/17-9/18, regular heavy bleeding 9/4 x 3-4 days.
Sister in law who is a RN states this patient's symptoms started with "flu-like" symptoms and his face was "swollen and glowing red.His cheeks, eyes, fingers, knuckles, ankles, all were swollen". She further stated that he had no difficulty breathing and that he was always alert and oriented.She did not take his temperature until after tylenol had been given and then she reports a temperature of 91 degrees F. She states she believes he may have had a fever of as high as 104 degrees F, but did not take his temperature to varify that. She stated that his normal blood pressure is 104/60 and that his blood pressure during this time when he had these symptoms was 84/44. She reports having pushed fluids to hydrate him. Her husband is a physician and they monitored him throughout the night and his symptoms decreased. Today, 5-8-14 at 2:45 pm when she phoned to report these symptoms, she reports that he is doing much better, his blood pressure is within normal limits and all of the swelling has subsided.
A few minutes after receiving the vaccine. Pain started shooting up from my left arm to my neck and head, giving me a terrible headache. Then the pain continued to spread down though my whole body. My muscles all stayed sore through that whole first day and some shooting pain when muscles were moved. My day to I still have a headache and muscle were some sore but the shooting pain was getting worse when I used my muscles. I took muscle relaxers and slept which did help some. Day 3 I still had a headache but my muscles felt of when I first woke up. About 3 hours after I woke up the shooting pain was too much to move barely at all.
mom states about 10hr p/vax pt devel a fever, fussy, pain @ site of inj & redness on rt thigh;
Patient received second dose of Pfizer on Wednesday 9/15/2021. She noticed some swelling by her collarbone the next day and stiffness in her arm when trying to raise it. She did experience body aches and fatigue from the vaccine as well. Around Sunday, 9/19/2021, she noticed the redness and swelling migrated from her collarbone to her neck/shoulder area. She has not taken anything yet, but states it has not gotten any better. The pain and swelling continues to be localized to this area and was palpated by pharmacist on duty today on 9/21/2021. It was noted not to be any warmer than the rest of that area, but was noticeably swollen, traveling along the lymphatic system in that area. It was recommended to try taking ibuprofen to help with the swelling and pain, but if it does not get any better or worsens to seek medical attention at an urgent care or emergency room.
headache, productive cough, body aches, sinus congestion, nasal congestion, post nasal drainage. she also has fatigue. starting on 9/25/21. Her 3-year-old son tested positive yesterday for Covid. (9/27/21)
Around a week after I had my dose 4 vaccine I noticed shortness of breath. I contacted my PCP and let her know what was going on and she ordered an echocardiogram and a stress test. Echocardiogram was normal but I have not been given the results of the stress test yet. I am feeling about the same today. I still have to stop to catch my breath when walking. I am still under doctor care at this time.
9-13-16. Noted to have pink vesicular rash on erythematous base (approximately 30 lesions). Believed to be mild case of varicella in vaccinated 6 year old.
clicking in my ears and different high pitched sounds; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown), via an unspecified route of administration on 05Apr2021 at 12:30 PM (at the age of 46-years-old), as a single dose for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history included COVID-19 (diagnosed prior to vaccination). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 12:00 PM, the patient had clicking in the ears and different high-pitched sounds. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the clicking in my ears and different high pitched sounds was not recovered at the time of this report.   Information about lot/batch number have been requested.
excruciating back spasms cont throughout the day lasting 3 days & cont;apply heat rx Ibuprophen, bedrest;
she received the 2nd shot, her lupus was reactivated; This spontaneous case was reported by a nurse and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (she received the 2nd shot, her lupus was reactivated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Systemic lupus erythematosus.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (she received the 2nd shot, her lupus was reactivated) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (she received the 2nd shot, her lupus was reactivated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that 30 days later, after the patient had received the second dose of the vaccine, the lupus had re-activated.  No treatment drug information was provided.  Company Comment: This spontaneous case concerns an unknown-years-old female patient, with  medical history of Systemic lupus erythematosus who experienced the unexpected seriousness criterion medically significant event of Systemic lupus erythematosus unknown days after  2nd.  dose of  mRNA-1273 vaccine.  It was reported that 30 days after the mentioned dose of the vaccine, the lupus had reactivated; on an unknown date the antibody test was positive. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   Reporter did not allow further contact; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old female patient, with  medical history of Systemic lupus erythematosus who experienced the unexpected seriousness criterion medically significant event of Systemic lupus erythematosus unknown days after  2nd.  dose of  mRNA-1273 vaccine.  It was reported that 30 days after the mentioned dose of the vaccine, the lupus had reactivated; on an unknown date the antibody test was positive. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Enlarged Heart. Pumping at 20%. Never had any heart issues befor this always normal physicals and ekg's.
On-off stomach ache; Feeling hot and her feet were sweaty; Started feeling cold; Feeling hot and her feet were sweaty; Little body ache; Little bit of fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty) and MYALGIA (Little body ache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, CITALOPRAM and ALPRAZOLAM (XANAX) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty), MYALGIA (Little body ache), FATIGUE (Little bit of fatigue) and CHILLS (Chills). On 07-Apr-2021, ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty), MYALGIA (Little body ache), FATIGUE (Little bit of fatigue) and CHILLS (Chills) had resolved.
22MAR fever, appeared aching, vomiting, diarrhea, high fever & mom felt area under ears swollen; to hosp 26MAR-29MAR dehydration; MD felt viral & not related to shots;
autoimmune hemolytic anemia w/avid IgG warm antibody;jaundice;hgb down to 4.8;hct to 14.0;