chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My mom received the first does of the shot on April 14, 2021 around 10:15 am. Her friend that took her told me that she was having a reaction to it when he took her home that day. He said she had the chills really bad that he had to turn the heat on in the car and give her a coat. He said later she was sweating. She didn't make any calls on her phone after 5:20 pm. Her sister found her dead inside her home the next day.
With in 15 minutes, we just left the dr office and were in the car ride home, he started to laugh/ cry that his left side of face was numb and droopy. Started to talk strange and I looked over and his left side of his face was droopy and he had tears in his eyes. I called the doctors office immediately. Once we got home, 15 minutes later it was gone but he was tired. The next day (Friday)around 1pm he complained of a headache and had a fever of 102.3. The remainder of the weekend, he had fevers from 101-103.7, was exhausted, weak. He was able to stay hydrated and still ate but mostly slept. That Monday I took him to doctors again. Complained. Dr was stumped and was going to do research on shots. Told me to continue with Motrin, advil. If still fever on that Wednesday to call again. His fever ended Wednesday but to this day he now has a dry cough and still exhausted. He plays soccer and is very active. He was perfectly healthy walking in for these shots and no one will convince me this was a fluke virus thing. A healthy person does not walk in for a shot and walk out with bells palsy.
This spontaneous report was received from a medical assistant and refers to a 5 unspecified patients of unknown age and gender. The patients' medical histories, concomitant medications and drug reactions or allergies were not reported. On multiple unknown dates, the patients were administered doses of improperly stored VARIVAX injection (lot # reported as N007937 with expiration date at 08-MAR-2019, for prophylaxis; strength, dose, route of administration and anatomical location were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). The administered doses of vaccine were exposed to a temperature excursion between 6 degrees Fahrenheit (F) and 14 degrees Fahrenheit (F) for 1 hour and between 15 degrees Fahrenheit (F) and 46 degrees Fahrenheit (F) (also reported as 36 degrees Fahrenheit (F)) for 4 hours. There was no previous temperature excursion. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. Lot number N007939 is an invalid lot number for varicella virus vaccine live (oka/merck). Additional information has been requested.
This spontaneous report as received from a consumer refers to a 69 year old male patient. The patient's drug reactions or allergies were reported as none. In May 2012, the patient was vaccinated with one dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included losartan potassium (manufacturer unknown), levothyroxine sodium (manufacturer unknown), omeprazole (manufacturer unknown), furosemide (manufacturer unknown), simvastatin (manufacturer unknown), sertraline hydrochloride, tolterodine, amlodipine besylate, clopidogrel, metoprolol succinate, doxazosin and clonazepam. In August 2015, the patient had an unspecified herniatic stomach surgery (also reported as the patient's medical history). IOn 08-MAY-2016, the patient developed shingles. He experienced hot flashes, pain in his eyes and head, and had difficulty sleeping. The patient went to a walk-in clinic and was directed to go to the emergency room (ER), where he received fluids and unspecified pain killers. He was prescribed unspecified pain killers and an unspecified antibiotic. The patient said that the antibiotic he was given "knocked (the shingles) down some" but he continued to have symptoms of the shingles, especially the pain in his eyes. Laboratory diagnostic studies were not performed. The patient did not received another dose of ZOSTAVAX (also reported as "no reintroduction - one vaccine"). The outcome of the unspecified herniatic stomach surgery was not reported. Causality assessment was not provided. Additional information has been requested.
Information has been received from a registered nurse, through the pregnancy registry, concerning a 32 year old female with a medical history of a miscarriage in September, 2001 who on 5/3/02 and 6/7/02 was vaccinated with a first and second dose of varicella virus vaccine live, respectively. Subsequently, approximately three weeks following the second dose, she became pregnant. She called the physician's office on 7/23/02 and reported that she was 3 weeks pregnant, "her LMP was6/17/02 and was heavier than usual and she had several positive home pregnancy tests." The pt was advised to come to the office that day for a blood pregnancy test. "On 7/24/02 the pt was called to report the pregnancy test result from the 24th was positive." The EDC was determined to be 3/5/03. It was noted that the pt had exhibited no signs or symptoms. "The pt delivered on 2/20/03, a month early, a male with a birth weight 6lb 7oz." "The pt reported the baby was in the ICU for 1 week after birth because "lungs needed help." On 5/23/03, it was noted that the pt reported the baby was doing fine and was healthy and the pt was also "good." Additional info has been requested.
After receiving vaccine, started feeling nauseous while in the observation area. Was brought by staff to the EMS room. Patient spit once but had no emesis. Patient stated she did not eat prior to vaccination.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 18-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than an hour after receiving BEXSERO, the patient experienced fever, fatigue and feeling unwell. The patient was treated with BENADRYL. On an unknown date, the outcome of the fever, fatigue and feeling unwell were recovered/resolved. It was unknown if the reporter considered the fever, fatigue and feeling unwell to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. Within 1 hour after receiving BEXSERO, the patient developed high grade fever of 102 to 103 degrees F, fatigue and overall ill feeling which lasted for about 48 hours. The patient was treated with BENADRYL at which symptoms have completely resolved. No further details were reported regarding the events. Lab Comments: Lab test was done on an unknown date.
Pt vaccinated with DTP developed liver inflammation within 48 hrs after immunization on 25JUN90. Seen 27JUN with mild jaundice & elevated liver enzymes. Resolved quickly. Probably viral.
This is a 6 Months  old  Female, with mom, with upper respiratory infection symptoms x 1 days.  Mother states that the patient received vaccinations yesterday and that early this morning the patient began to have vomiting, fever, shaking, and looked pale.  She states that she did attempt to give the patient Tylenol but the patient immediately vomited it up.  She states that the patient has been unable to keep anything down since this morning.  Symptoms viewed as moderate by parents. Better with nothing, worse with nothing.  No history of other contacts with same symptoms. No travel overseas.
Gradual onset of substernal chest pain increasing to 7/10 over a 7 minute period and then gradually decreasing over the next 5 minutes.  No shortness of breath, diaphoresis, DOE, or radiation.
large whelp @ site of DTAP given 20hr p/vax by phone;no resp problems noted;instructed to give DPH as directed & RTC if sx worsen;
Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was at the VA today getting his 2nd Covid vaccine (Pfizer) and during the post vaccine waiting period, he developed frontal headache and transient L arm tingling.  He was sent to ED in Superior and BP was as high as 219/114.  He was given amlodipine and toradol and dilaudid and BP did not come down.  He also had a slight elevation in troponin and had second episode of L arm tingling.  Decision was made to not give ntg since he already had a headache.  No chest pain or other neuro sx. Head CT neg for bleed. No chest pain. Patient presented to the ED again on 5/11/21 with similar symptoms as previous visit.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On an unknown date in October 2007, the patient was vaccinated with the first dose of COMVAX (lot number, expiry date, dose and route unspecified). On an unknown date in October 2008, the patient was vaccinated with the second dose of COMVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
on 11/ 21 patient presented to the ER for COVID-19 symptoms and was discharged home x-rays with pneumonia was empirically placed on steroids, REMDESIVIR with breathing treatment he required oxygen supplementation escalated to high-flow oxygen supplementation. on 11/23 he returned with worstening SOB.   Initially, CRP severely elevated to 29.6 trended down.   Id started patient on  Baricitinib.  Patient responded well to treatment CRP trended down.  CBC revealing thrombocytosis likely due to COVID-19 infection and pneumonia.  CBC blood work is being in 1 week to monitor the platelet count.  Patient has been updated even though this may be due to COVID-19 infection it is what the while to rule out other life-threatening medical condition.  He was discharged in stable condition and room air.
Mom stated about 10:00 on the same day, pt began hallucinating. This lasted all night and gone by AM. Had same reaction with 1st HBV given 6 months before.
Patient presented with chest tightness, SOB, generalized pruritus and redness, increased HR & BP, peripheral swelling.
Information has been received from a consumer concerning his 14 year old daughter with latex and a lot of other unspecified allergies who on unknown dates was vaccinated with two doses of GARDASIL vaccine in arm. There was no concomitant medication. "After the first dose" of GARDASIL vaccine, the patient experienced an itchy rash, the injection sites irritated and had pale spots. The caller thought his daughter might have and allergic reaction to GARDASIL vaccine because she had a lot of allergies. At the time of the report the patient received 2 doses already in both arms and arms had itchy rash now that was not going away. The patient sought medical attention. Additional information has been requested.
very weak; need oxygen constantly; everything went downhill; feeling bad; This spontaneous case was reported by an other and describes the occurrence of ASTHENIA (very weak), OXYGEN CONSUMPTION INCREASED (need oxygen constantly), UNEVALUABLE EVENT (everything went downhill) and FEELING ABNORMAL (feeling bad) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INSULIN GLARGINE (INSULIN GLARGINE BIOMEP) injection for Type 2 diabetes mellitus.    Family history included Diabetes mellitus (type I and type II diabetes mellitus). Concurrent medical conditions included Corrective lens wearer, Type II diabetes mellitus, Congenital heart disease NOS and Non-smoker. Concomitant products included INSULIN LISPRO (HUMALOG), APIXABAN (ELIQUIS) and CORTISONE for an unknown indication.   In 1991, the patient started INSULIN GLARGINE (INSULIN GLARGINE BIOMEP) (Subcutaneous) IU at bedtime. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, INSULIN GLARGINE (INSULIN GLARGINE BIOMEP) (Subcutaneous) dosage was changed to 40 IU once a day. In April 2021, the patient experienced ASTHENIA (very weak) (seriousness criterion hospitalization), OXYGEN CONSUMPTION INCREASED (need oxygen constantly) (seriousness criterion hospitalization), UNEVALUABLE EVENT (everything went downhill) (seriousness criterion hospitalization) and FEELING ABNORMAL (feeling bad) (seriousness criterion hospitalization). The patient was hospitalized from 20-Apr-2021 to 26-Apr-2021 due to ASTHENIA, FEELING ABNORMAL, OXYGEN CONSUMPTION INCREASED and UNEVALUABLE EVENT. The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (very weak), OXYGEN CONSUMPTION INCREASED (need oxygen constantly), UNEVALUABLE EVENT (everything went downhill) and FEELING ABNORMAL (feeling bad) outcome was unknown.            Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. Company 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.; 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.
Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PRURITUS (Itchiness). At the time of the report, PRURITUS (Itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Chills; got a temp 99.9 used his temperature about and he had a fever; Vomiting; Coughing; Shortness of breath; Tightness in chest; This is a spontaneous report from a contactable consumer (patient himself). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207), via an unspecified route of administration, on 18Mar2021 10:00, at a single dose, for covid-19 immunization. Medical history included blood pressure. Concomitant medications included unspecified blood pressure medicine and blood thinner. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) on 25Feb2021 for covid-19 immunization. The patient stated he had the second shot of the Pfizer vaccine and he had a reaction. He got the shot on Thursday, 18Mar2021 at 10:00 and about 21:00 (also reported as 6 hours after the shot), he was getting chills, got a temp 99.9 used his temperature about and he had a fever, vomiting, and coughing, kind of shortness of breath, and tightness in chest and that was about it. The patient was still experiencing shortness of breath, tightness in chest, vomiting, fever and coughed a lot too. No treatment was received for the adverse events reported. The patient stated he was feeling better today than he was yesterday. The patient was recovering from the adverse events at the time of the report.
sudden onset severe tinnitus, woke me from a sound sleep. has gotten worse since the onset. It is there all the time.
Severe fatigue, malaise, myalgia which lasted for 18 hours Ibuprofen helped significantly reduce the symptoms
Child woke with large indurated red swollen area to left deltoid, approximately 4" in diameter.  Red, hot and painful to the touch.
2nd dose a week after the first; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was reported. The pharmacy intern reported that, the patient received 2nd dose of Shingrix, a week after the first dose, which led to shortening of vaccination schedule. The reporter had no other information about patient at the time of the report. The reporter consented to follow up by phone.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
10/21/11 FLUMIST. 10/23/11 URI & fever onset. 10/26/11 Myalgia onset. 10/27/11 Refusal to walk with calf tenderness. 10/28/11 AF walking today.
started out tender, then found a spot smaller than a dime, now the size of a fist;sl raised w/hard spot;sl warm;
Child over age 12 years received the 5-11 yo dosage of the vaccine.  This was his first dose, and he will receive the appropriate second dose at the appropriate time.
Chills , Fever, weak,  sweating , completely wet hair,  for one week . 2nd week very  weak.  Third week. still Feeling weak And  Flu like symtoms and headaches
Every single side effect on the sheet - began with muscle soreness about 2 hours after the shot, which lasted about 1 week.  Around 2:30am the morning after the shot, I was awakened from a deep sleep by chills and sweats, which lasted for about 36 hours from that moment. These were moderate to severe, such that these symptoms alone would have prevented me from making it through the workday. However, things got worse. Due to chills and sweats, I took my temperate, which was about 99F at that time. Over the course of the next 10 hours the temperature spiked to 100.4F oral.  I tried to go back to sleep at 2:30am, but I could only toss and turn due to the chills. Perhaps due to lack of sleep, perhaps due to vaccine, I developed a head ache  and some nausea - both of these are extremely rare symptoms for me, as I rarely have a headache more than once a year. By 5am, with climbing temp, sore arm, headache, upset stomach, chills, sweats, muscle aches and exhaustion, I consulted my boss - a 20 yr clinical pharmacist - who advised me this would end after 24 hours. Therefore, I took no meds and waited it out.  Soon after 12:30pm, when the fever reached 100.4F, I felt the temperature break. It was almost 24hrs to the moment, and after that the symptoms began rapidly resolving. The temperature subsided completely by about 7pm that evening. Chills and sweats the next morning. Some fleeting headache and nausea the following day. A lot of dizziness and faintness over the next week or so, which I am unsure about - but it could be some sort of backup/accumulation of high dose Mg for my back, in the presence of the vaccine and/or immune response.  I say below that I visited the doctor because, if my boss were not a clinical pharmacist, I would absolutely have made a doctor's appointment.  Because I get COVID19 tested at work, I had no need to make an MD appt.  I got COVID tested, and I consulted with a clinical COVID19 expert - better than a doctor's visit given how long it takes to get in to see my PCP and how little he knows about COVID19  vaccine responses.
Patient described left arm pain,  the arm that received the vaccination, and reported discomfort in the left leg as well.  Routinely checked her blood pressure and it was elevated 180/118mmHg.  Waited a few minutes and checked again with similar results.  She denied any other symptoms.  She was advised to have her blood pressure checked out.  She refused the offer of EMS, and stated she would have it checked today.  She left and it is unknown at this time if she was seen in the ER as advised.
Parent called the office to make Doctor aware patient left deltoid where he received the flu shot was swollen.
12 hours after receiving my moderna booster I experienced the typical  fever, lethargy etc. which resolved within a day.  My left arm was slightly sore, but by the morning of the 13th I had shooting pain from my wrist to my shoulder. I have never experienced this level of pain and it increased throughout the week. It was painful to work and to drive. I woke up 3x/night from arm and shoulder pain even when sleeping on my right arm (shot was in left arm).  A week after the shot I started having muscle spasms in my left arm. I am still experiencing arm pain and shoulder pain over two weeks since the booster shot. It has improved a bit but is still there. My primary care doctor offered no advice but to take ibuprofen. I have taken this and it takes the edge off slightly but not much and the symptoms are always there. I have no issues with reduced arm movement. I left the band-aid from the shot on and was able to see the shot was placed in my deltoid muscle- not too high. I experienced no arm pain from the shot itself, but the aftermath has been horrible. I hope this pain will go away but I am not sure if it will.
fully vaccinated using Janssen on 6/10/21; s/o 8/27/21, tested + 8/28/21
NONE COVID 19 VACCINE EXPIRED 11/22/2022 GIVEN: 01-10-2023
SINUS SYMPTOMS; DRYNESS; SORE ARM; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced sore arm. On 29-MAR-2021, the subject experienced sinus symptoms. On 29-MAR-2021, the subject experienced dryness. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 30-MAR-2021, and was recovering from sinus symptoms, and dryness. This report was non-serious.
Severe shaking of body, mainly arms and legs on 4/1/2021. Lasted on and off for 2 hours. Feeling very dizzy, slightly nauseous and my skin was crawling. Felt intoxicated. Tried to stay calm. Had taken Advil pm and went to sleep. Woke up the next morning feeling shaky, difficulty walking. Slight headache on top of head. Blurred vision would come and go. Took 1/2 Prednisone 20 mg (which I take when migraine severe). Felt better early afternoon. Again shaking while sitting down late afternoon 4/2/2021. Feeling weird. Slept through night. Next day only one episode of shaking.  During 10 days afterwards still periods of getting dizzy, feeling my heart beat in my ears, at times feeling confused, when typing my left hand sometimes fails to respond.