chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee c/o headache, nausea, vomiting, fever, rash on arms, neck, chest, abdomen and pain and swelling at injection site.
Pt appeared to have slight cough when presenting for vaccination. Patient was asked a series of questions before receiving Vaccine including the patient's current status and whether they are currently having any symptoms of Covid, Illness, or Infection. Patient denied any symptoms. Patient continued to have a slight but constant cough. Patient was given Pfizer Covid Vaccine First Dose 0.3mg. Within two minutes the patient began to show signs of anxious behavior. Patient suddenly said he "needs to walk" and got up from his chair. He walked down a small hallway with the LPN who administered the Vaccine following close behind. Patient was asked if he was SOB and he stated he was. Patient sat down in waiting room. Patient was asked to return to the Covid Vaccine Clinic for assessment. On his way back to the Clinic, the patient had to take many pauses to breath. Patient was asked if the SOB was sudden after receiving Vaccine and patient denied this and stated that he was feeling SOB prior to arriving. Upon return to the Covid Vaccine Clinic the patient had an SpO2 attached and patient's O2 was at 81% on room air.  Emergency Response Team was notified of situation. O2 was provided at 2L via cannula and patient SpO2 raised to 85%. Patient's PCP was notified and responded to the Covid Vaccine Clinic. Physician was informed of vitals and immediately had EMS called. 02 was increased to 4L and patient's levels raised to 89% but began to decline to 86%. Patient exhibited tachycardia and was diaphoretic. 02 was increased to 6L with patient declining to 84%. EMS arrived and took over control of care.   Upon arrival, he had complaints of nausea and vomited multiple times. He was placed on monitor and oxygen saturations were reading 53% and HR 120's with rhythm concerning for atrial fibiralltion. He became minimally responsive requiring BVM and was then emergently intubated for airway protection with etomidate, succinylcholine, 150 mcg of fentanyl and 3 mg of IV ativan. After intubation, he became profoundly hypotensive with SBP 50s and MAPs in the 30s. He was given 100 mcg of IVP phenylephrine and was initiated on Norepinephrine infusion to maintain MAPs > 65. His initial troponin-1 was 196 . He was started on a Heparin infusion and bedside ECHO with EF 35%.  Diagnosed with Stress-induced cardiomyopathy with  Takotsubo presentation.  Of note, since being diagnosed with COVID 19 in October 2020 he had worsening dyspnea with intermittent chest pain., but had not yet followed up with pulmonary and cardiology docs.
Today I first noticed that I have , what is known as ? ? ?Covid Arm? ...or a red, somewhat splotchy, itchy rash on or around injection site.
The patient began experiencing symptoms 30 mins. after the vaccination was given. He reported sudden sense of nausea, tunnel vision, headache and light sensitivity. He returned to the clinic shortly after leaving due to his condition. We had him rest in one of the outpatient rooms while monitoring his vitals, was also given an instant ice pack for his head. The pt. was prescribed Banophen (anti-histamine), Ondansetron for nausea and Ibuprofen 800mg for pain relief. He was given 6 TAB of both the Ondansetron and Ibuprofen but took 1 tablet of each of the 3 medications after coming into the exam room. Our patient relaxed in the room and was closely monitored for 45mins.-1hr. following coming back. Pt. began feeling better about 30mins. into his stay where he waited another 20-30mins. to ensure symptoms resided and he felt better. He was free to leave once better. Instructions were to contact our clinic or return if the headache or nausea returned or if his symptoms worsened.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was vaccinated with an improperly dose of MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150; US-009507513-1701USA007912:Original Case : 1701USA007906; US-009507513-1701USA007922:Original Case : 1701USA007910; US-009507513-1701USA007881:Original Case : 1701USA007910; US-009507513-1701USA007913:Original Case : 1701USA007910; US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
This spontaneous case was reported by a nurse and describes the occurrence of NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Based on case narrative, the patient was just asking when is the ideal date of booster dose after a Covid-19 infection. Patient did not state that he tested positive after Moderna vaccination. Hence, this case needs to be invalidated.
PT STATES THAT SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, MYALGIA, WEAKNESS  AND THE INABILITY TO LIE FLAT THE EVENING OF THE VACCINE ADMINISTRATION. PT STATES THAT THE SYMPTOMS HAVE NOT  IMPROVED SINCE THEY BEGAN, BUT THAT THEY HAVE BECOME MORE INTENSE.
Onset of vomiting, headaches and dizziness 30 minutes after HPV vaccine. (Non-allergic or non-hypersensitivity).
Patient tested positive for Covid19 after being vaccinated with Janssen Vaccine EUA 05/27/2021
no adverse event, patient reported that they had also received a  vaccine at a school clinic only after getting their second  shot.  neglected to mention this in written and verbal screening prior to getting the vaccination
This spontaneous report was received from a pharmacist concerning a 57 year old female patient.  No patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were reported. On 18-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R018732, expiry date: 27-FEB-2020, for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided). On 20-OCT-2018, the patient experienced Injection site arm and hand inflammation and fever. The patient was treated on the same date with unspecified ibuprofen. The outcome of injection site inflammation, pyrexia, feeling hot and injection site warmth was reported as resolved. The reporter's causality assessment between PNEUMOVAX 23 with injection site inflammation, fever, feeling hot and injection site warmth was not reported.
This spontaneous report has been received from a licensed practical nurse referring to a 15 month old female patient. The patient did not have pertinent medical history, drug reactions or allergies, concurrent conditions or concomitant medications. On 02-MAR-2018, the patient was vaccinated with improperly stored doses of VARIVAX lot # N021719 with expiration date of 10-AUG-2019, 5 ml (anatomical location and route were not provided) for prevention of varicella. Other suspect therapies included M-M-R II lot # N013867 with expiration date of 04-MAY-2019, 0.5 ml (anatomical location and route were not provided) for prevention from measles, mumps and rubella. No adverse events were reported. The patient did not sought medical attention and none laboratory studies were performed.
Mom reported 24 hours post immunization patient had " involuntary head jerking." Took child to doctor, nothing found as to cause the "head jerking." Mom states it is starting to subside.
3 days after the first dose I thought I had food poisoning. Vomiting and diarrhea for about 4 hours, then nausea and diarrhea for about 5 days after. I haven't eaten anything out of the ordinary recently that could have given me food poisoning and it's so far been the same symptoms, just a day delayed.
Information has been received from a physician concerning an 11 year old female with no drug reactions or allergies who on 19-APR-2010 was vaccinated with the third dose of GARDASIL (lot # 661766/0652X) 0.5 mL, IM. There was no concomitant medication. The physician reported that 18 hours later, the patient's mother called the office and stated that her daughter experienced dizziness. The physician suggested taking fluids and had not heard from the patient since. The patient sought unspecified medical attention. No further information is available.
Client received the 1st dose of COVID vaccine by Pfizer lot # EW0161 and expiration date 4/17/2021 at 1:37pm. At 1:45pm client reported to EMT that he felt itchy on his left arm around injection site.  PHN arrived and noted client was alert and oriented x 4.PHN  removed tape from clients arm and observed redness near injection site. Client reports no shortness of breath and no itchiness anywhere else. PHN offered client Benadryl, but client reports he will be driving. Client reports he has a history of high blood pressure, fatty liver, and high cholesterol. Client takes atorvistatin and valsartan. PHN takes vitals at 1:48pm: oxygen: 99% and pulse: 73 and blood pressure: 120/80. At this time client reports itchiness is gone.  At 1:58 PM vitals are pulse: 72, blood pressure: 126/76 and oxygen: 97%. Client is alert and oriented and reports no symptoms.  At 2:08 pm pulse: 72 and blood pressure 126/88 and oxygen: 98% client reports no itchiness.  Client left facility with a steady gait at 2:15pm.
Immediate swelling and local fever in arm tightness. Pt used ice packs and Ibuprofen (800) during the night. On 9/27 saw Dr prescribed antibiotic and pain mediation.
Asthma      with headache, fever and body pain. Needs a refill for asthma meds     HPI 7 year old male history of asthma presents with shortness of breath. Brother diagnosed with covid 2 days ago. Mother also notes fever, abdominal pain. Did not take anything for the symptoms. Patient is out of his asthma medication and requesting refill. Patient is vaccinated for COVID. Childhood vaccinations up-to-date.
DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-2951) was received from a pharmacist on 27-Nov-2019. It described a 6-year-old male consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took the first dose of Vivotif on 23-Nov-2019 and then he did not take the second dose of Vivotif according to schedule, and took it one day late on 26-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: It was reported that a patient did not take Vivotif according to the schedule (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: It was reported that a patient did not take Vivotif according to the schedule (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Pt received SPV left arm on 4/4/09.  On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10).  He states that he felt like his heart rate was increased.  He did not have SOB, N,V, diaphoresis, radiation of the pain.  The pain was not affected by activity, position or deep breathing.  Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes.  Again, it was non positional, did not radiate, and the pt had no associated symptoms.  He went to the VA ER on 4/13/09 where he had a negative work up and was discharged.  The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable.  Pt instructed to start taking MOTRIN 600mg qid with food.  The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms:  Chest Pain.
Flushed, chills, headache, lightheaded. Pt called clinic to report symptoms. No treatment.
COVID 19 Treatment / Rebound covid; COVID 19 Treatment / Rebound covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 12:00 as dose number unknown, single (Lot number: Eng202) at the age of 47 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. 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 / Rebound covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment of Paxlovid for covid-19 from 8Jun2022 to 12Jun2022.  No follow-up attempts are possible. No further information is expected.
Child reported legs hurting night of shots and following day. Child had a seizure the following day and was sent to ER. Child vomited, lost consciousness and had convulsions.
About a week after the vaccine , left arm and leg were numb, tingly . Two weeks after , she can barely walk at all with her left leg. We researched GBS,which she seems to be experiencing all symptoms of this .
Patient felt dizzy and felt heartbeat change within a couple minute of shot; was not alert for approximately less than one minute and showed some possible convulsions; patient came to and became aware of surroundings and symptoms slightly improved; blood pressure was stable until medical professionals arrived on site for additional help
On 5/6/2023 at about 7 PM, I became incredibly weak, and my sinuses were blocked. On the morning of 5/7/2023, I woke up and continued to be very tired and had a temperature of 101.9. I then took two home antigen tests and got a positive result on both of them. Later that night, I developed a dry cough. That night, I got very limited sleep. On the morning of 5/10/2023, I called my doctor, who prescribed me prednisone, a Z-Pak, loratadine, and an albuterol inhaler to use in case of chest tightness and breathing issues. I have not had to use the inhaler. I asked for Paxlovid, but for some reason, he refused to prescribe it to me. On 5/9/2023 and 5/10/2023, I saw no improvement, but I did see improvement on 5/11/2023. I experienced no coughing, no fever, and reduced sinus congestion. As of now, my sinuses are almost clear, and I have regained about 85% of my normal energy level. I continue to have no coughing and no fever. I lost my senses of taste and smell on 5/8/2023, but they are now improving.
Headache, Arthralgia, Fever, NauseaVomiting, Fever, chills, severe fatigue, severe lower extremity aching, mild headache mild nausea Narrative:
Headache, Itching, Fatigue, Rash on leg,  symptoms started within 2 hours of the shot, and have not gone away after 16 days
Severe fatigue, headache, fever. When those symptoms started going away, my left underarm lymph node swelled and became extremely painful. As of the time reporting this my underarm still hurts.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-MAR-2017, the patient was vaccinated with a first dose of VARIVAX, subcutaneously (site of administration, lot number and expiry date were not reported). On 24-MAR-2017, the patient received the second dose of VARIVAX, subcutaneously, lot # M028549, expiry date 07-JUN-2018 (site of administration was not reported) with sterile diluent (manufacturer unknown) (dose, lot # and expiry date were not reported). No side effects reported. Additional information has been requested.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
heart attack; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (Patient Friend).  This case involves an adult patient of unknown demographics who suffered heart attack after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (form, strength, route, administration site, batch number expiry date: unknown) for immunization.  It was reported patient was in perfect health.  On an unknown date the patient suffered a serious event of heart attack (myocardial infarction) (unknown latency) following the administration of Influenza Vaccine.   Action taken was not applicable  Corrective treatment: not reported  Outcome was Fatal   The event was assessed as medically significant and was leading to death.  It is unknown if an autopsy was done. The cause of death was reported as Heart attack.; Sender's Comments: Sanofi Company Comment dated 28-Feb-2022: This case involves an adult patient of unknown demographics who suffered heart attack and died after receiving Influenza Vaccine.The causal role of the company suspect drug cannot be excluded based on the temporal relevance instead of the time to onset is compatible with the role of the vaccine. However, information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: heart attack
Systemic: Chills-Mild, Systemic: tingling in fingers-Mild; symptoms lasted 0 days
Vaccine administered 5/6/08- Parent reports shot he broke out into chickenpox soon after- Patient doing fine 7/22/08
headache; Aches and pains/ body hurts; wrist hurts; temperature 99.8 F; my eyes hurt, feel better when closed; sweating; just don't feel good; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (my eyes hurt, feel better when closed), HYPERHIDROSIS (sweating), FEELING ABNORMAL (just don't feel good), HEADACHE (headache) and MYALGIA (Aches and pains/ body hurts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MESALAMINE, VITAMIN D2, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3) and ALGAECAL PLUS for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced EYE PAIN (my eyes hurt, feel better when closed), HYPERHIDROSIS (sweating), FEELING ABNORMAL (just don't feel good), MYALGIA (Aches and pains/ body hurts), ARTHRALGIA ( wrist hurts) and PYREXIA (temperature 99.8 F). On 29-Apr-2021 at 4:00 AM, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, EYE PAIN (my eyes hurt, feel better when closed), HYPERHIDROSIS (sweating), FEELING ABNORMAL (just don't feel good), HEADACHE (headache), MYALGIA (Aches and pains/ body hurts), ARTHRALGIA ( wrist hurts) and PYREXIA (temperature 99.8 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 99.8 (High) Body temperature was 99.8 F.         Concomitant medication taken by the patient included  Multicomplete. The patient took two tablets of Tylenol 500 mg each by mouth as a corrective treatment at noon on 29-Apr-2021 and woke up sweating at 2-2:30 pm. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-098136 (Patient Link).
High fever to 105 degrees: prolonged fever x 10 days arthralgia, general malaise, irritability.