chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to three unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (lot #, expiration date, dose and frequency were not provided). On an unknown date, the patients experienced mild shingles after receiving ZOSTAVAX. No concomitant therapies were reported. The outcome of mild shingles was unknown. The causality of ZOSTAVAX regarding the event mild shingles was not provided. Additional information has been requested.
5 TH COVID MODERNA DOSE -1ST UPDATED BI-VALENT BOOSTER-The patient reported fleeing headaches 24 hours after her vaccines, brain fogginess 48 hours after her vaccine, and numbness and tingling in her arms and legs that she had to repeatedly rub which improved several days later
Patient came to the ER with shortness of breath with any exertion, slight fever, cough, loss of appetite, diarrhea, fatigue, nausea, vomitting. Tested positive for COVID 11 days ago. Was given vancomycin for suspected sepsis. Also had acute kidney injury and treated with hydration. Cystitis was also present and treated with rocephin. Was given supportive care for COVID. Discharged in stable medical condition.
One to two days subsequent to receiving one dose of varicella virus vaccine live the pt developed a generalized varicella like rash. The pt was seen in the ER and the physician thought her rash was chickenpox.
pt recv vax 21APR98 & 23APR98 c/o swollen face, rash/hives on arms, chest, pruritus, some problem breathing worsening until 24APR98;pt reported a little rash & itching;5MAY a little on arms & states rash was red;rash spots size tomato seed
Administered Pfizer vaccine 12 years and up to an 11-year-old patient. No adverse effects to the Pfizer vaccine.
patient with history prior adverse reaction to flu vaccine flu vaccine given in error subsequently developed shortness of breath & chest pain & fatigue symptoms improving with steroids referred to allergist for ongoing management
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Autoimmune Disease (diagnosed by MD)-Severe, Systemic: Bell's Palsy-Severe, Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Severe, Systemic: soreness that was from the anterior deltoid to the interior of the elbow-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Heart Attack-Severe, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Hypotension-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Severe, Systemic: Nausea-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Stroke-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: no pain at injection, but anterior and not pain, but a soreness
27cm from injection site a 15x15cm soft nodule appear while appling pressure to syringe with some resistence noted. Soft nodule with reddnes and no inflmation to surrounding area noted. Client denied pain, itching or any discomfort.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients, of unknown ages and genders. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of GARDASIL 9 Lot # L023230, expiry date on 28-JUL-2017, were inadvertently administered to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Discharge from eyes, sensation of tightness and congestion in lungs, soreness and aching in arm, shoulder and neck of injection site.
Pt received Gardasil vaccine.  5 minutes post injection pt c/o dizziness.  No other symptoms lasting approx 5 min.  Discharged to home with no further c/o.
Pt has a small red area at the sight of injection (approx 1/4 inch in diameter) that appeared shortly after immunization and has not gone away. Today marks one month since vaccination. Pt states the area is also itchy. No pain was reported at the sight.
was feeling down; has no appetite; fever; chills; extremely ill; slept over 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill), HYPERSOMNIA (slept over 36 hours), DEPRESSED MOOD (was feeling down), DECREASED APPETITE (has no appetite) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced ILLNESS (extremely ill), HYPERSOMNIA (slept over 36 hours), DECREASED APPETITE (has no appetite), PYREXIA (fever) and CHILLS (chills). On 01-May-2021, the patient experienced DEPRESSED MOOD (was feeling down). At the time of the report, ILLNESS (extremely ill), HYPERSOMNIA (slept over 36 hours), DEPRESSED MOOD (was feeling down), DECREASED APPETITE (has no appetite), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  Patient is concomitantly taking thyroid and water pill.
I first noticed a rapid heart rate around 114 on 03/24/2022. My blood pressure was high 238/129. I went to hospital and was in and out for 4 days. I went to the Hospital. I was having to go back in to get my blood checked. I was given Lisinopril and to only take it if I needed it.
Sharp shooting pain; head seems like on nerve; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in left arm on 12Feb2021 13:15 (at the age of 71-year-old) dose 1, single for COVID-19 immunisation at hospital. Medical history included atrial fibrillation, drug hypersensitivity to Sulfa, tetanus, aspartame artificial sweetener. Concomitant medications included verapamil, alprazolam, zinc received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 15Feb2021 12:00, patient experienced sharp shooting pain on certain spot the head seems like on nerve. Had the same pain once when given sulfa drugs. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of events was not recovered.    Follow-up attempts completed. No further information expected.
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (Lot number: EL3244) as dose 2, single for covid-19 immunisation. Relevant medical history included: "mental fatigue" (unspecified if ongoing); "physical fatigue" (unspecified if ongoing); "covid-19", start date: 08Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: 28Jan2021, for covid-19 immunisation, reaction(s): "chills", "fever", "fatigue". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: The consumer reported for a (age: 80, unit: Unknown) male patient (Husband) in response to non hcp letter sent in a cross referenced case that included: He returned the previous evaluation packet 2days after receiving it, following was a brief summary of the information: 1) The patient (husband) and I Wife) were healthy, active seniors, He was almost 80 and his wife was 77. 2) They contracted  covid-19 08Nov2020, it took them about 5 weeks to get over it especially the physical and mental fatigue. 3) The patient experienced fatigue but not too bad. 4)As of today 09Mar2021-I (we) have gotten better.  The patient age was not capture in tab because stated "Almost 80" hence added in narrative. This was male patient (husband) case hence added information of that only. Wife case information already took in cross reference cases.   No follow-up attempts are possible. No further information is expected.
Pt was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  nausea and flushed, lightheaded.   Assessment : Time of assessment 1250. Alert and oriented and Nausea. Patient reports as soon as she sat down after receiving the vaccine, she started feeling flushed, nausea and lightheaded. She walked out to the triage area. She asked for water and says when she drank the water, the nausea went away. After 5 minutes sitting, she reports the feeling of flushed and lightheaded went away. After additional observation, she ambulated without difficulty and was released to go home.   Actions taken:  Vitals sign taken   form obtained and completed by RN. 1250-BP: 148/101, P 102, 100% Oxygen Sat; 1302-BP: 146/99, P 77 (no symptoms at this time); 1310: BP 144/100 P 93 (no symptoms at this time).   There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 20 minutes minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
pt reported some mild pain to arm after 2 weeks of vaccination. has had symptoms of nerve pain in neck prior to vaccine and thinks there may be correlation. pt will just use selfcare overthecounter pain med or ice area but does not think necessary since pain mild
Received flu vaccine on 10/17/2007. On 10/18/2007 around 3 pm started breaking out in rash all over body. No fever or any other symptoms. Around 10 pm that same night child was taken to ER. ER MD advised mom to take child to doctor 2 days if no better. Noted rash all over hand, on face, arms, trunk and legs. No other
Pt presented to the ERT table with the feeling of her throat closing and dizziness. Pt had the same reaction on her first dose and was administered 25mg IM Benadryl and left the facility AMA with family. Pt stated that she was having the same reaction. Pt walked to the bed and took a seat. Paramedic drew up and administered 25mg IM Benadryl in the right arm. Vitals were assessed. Vitals were WNL excluding BP: pt stated that she had not taken her BP medications today and that was the reason for her high BP.  Pt stated that she was feeling better and that her throat felt less restricted. Pt remained with crew for approx. 30 minutes after receiving her vaccine. Pt's vitals were monitored and all were trending WNL for the pt. PT stated that her throat felt close to normal again. Pt was given the option for crew to call 911. Pt refused and stated that she had her epi pen with her and that she would seek emergency care if her symptoms persisted or worsened. Pt was encouraged to follow up with her immunologist and PCP.  AMA refusal was signed and pt and family were walked to the parking lot.
Administered vaccines and when patient stood up he became pale and c/o not feeling well.  Told patient to lay down on exam bed and gave apple juice, took vital signs - BP 96/58, P 77, Sat 98%.
Patient reports the fourth day of the administration with the first dose of Pfizer Vaccine, Itching, redness and swelling on the left side of his lips. He does not receive any treatment according to his father. At the time of receiving the second dose, the lesion was observed on the left side lips
Patient reportedly had seizure after placement of the Pfizer/BioNTech COVID-19 vaccine. The patient received the vaccine at a COVID vaccination clinic. The patient had vaccination needle in her arm, and then almost immediately after, within 3 minutes, that she had a seizure event. It was for extremity shaking lasting a couple minutes which then resolved. This was witnessed by family and they kept her from having any injury sustained. Reportedly she also was very scared receiving the vaccine and "when she gets scared she has her seizures".  Mother reports that the patient seizes about once a month and has had other seizures with interventions like brushing teeth. The patient has been taking her medications for seizures. Patient was postictal when medics arrived. Glucose was 79. No recent illness. No recent injury or fever. Had coronavirus over the summer.
p/vax broke out in hives on arm where MMR given; then frequent twitching of rt eye; taken to ER; eye twitching lasted few days; MD thought perhaps some type of seizure; pt ok now
Vaccine was being administered but it spilled out, so they ended up administering an other dose.; Vaccine was being administered but it spilled out, so they ended up administering an other dose.; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.    This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of DEVICE CONNECTION ISSUE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) and ACCIDENTAL OVERDOSE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.).     The patient's past medical history included No adverse event (No adverse event history).  On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) and ACCIDENTAL OVERDOSE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) and ACCIDENTAL OVERDOSE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator.  Treatment of this event was not provided.  Company comment: This report refers to a case of syringe connection issue and accidental overdose for mRNA-1273, lot # unknown  with no associated AEs   Reporter did not allow further contact
This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of M-M-R II injection, (lot # M027637; expiration date: 02-JUN-2018), (lot # reported as M029230; expiration date: 08-JUN-2018), (lot # M025607; expiration date: 18-MAY-2018), (lot # reported as M022407; expiration date: 02-MAY-2018), (route of administration, albumin status, strength and dose were not reported) for prophylaxis. The temperature excursion with M-M-R II was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA003446: US-009507513-1612USA010294: US-009507513-1612USA010291: US-009507513-1612USA010292.
On May 10, I started to have some pretty intense back pain which I never had before. This lasted for a couple of weeks. On May 23, I had vaginal bleeding. I went to my urogynecologist who sent me to an oncologist because they could not get a tissue sample. The oncologist did a DNC on July 06th and it showed that there was benign polyps blocking the neck of the uterus. The removed it and biopsied which confirmed they were normal with no sign of cancer there or in the uterine wall. I have had no further issues.
sick; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 14:30 (Lot number: EWO473) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Caller had a cold when took the shot." (unspecified if ongoing), notes: Caller had a cold when took the shot. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 04May2021, outcome "recovering", described as "sick"; FEELING ABNORMAL (non-serious) with onset 04May2021, outcome "recovering", described as "feeling bad".  Additional info: She had the Covid-19 vaccine on Monday. She had been feeling bad ever since. Patient was improving a little bit. The patient had not received any other vaccinations within 4 weeks prior to Covid-19 vaccine. Caller reported that caller think she will not take the 2nd dose if it does like this.   No follow-up attempts are possible. No further information is expected.
Received vaccine at 7:37 am on 1/26/21.  Felt a little off / stiff around 5:30 pm 1/26/21.  At midnight 1/27/21 began experiencing chills.  Could not control them.  Several blankets applied.  Then at 2:30 am 1/27/21 chills stopped.  At 3 am spiked a temperature of 101.8 until around noon 1/27/21.  After that temperature broke and just felt very run down.  1/28/21 - while sleeping felt better but soaked 6 tee shirts while sleeping.  Finally stopped wearing tee shirts and sweating appeared to stop.
lightheaded, dizzy, neusea B/P: 118/62 , RESPIRATION: 20, PULSE: 85
No additional AE reported; a dose of VARIVAX was administered after a temperature excursion; This spontaneous report was received from other and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W012167, expiration date: 12-APR-2024 (strength, anatomical location, and route of administration were not provided) as prophylaxis, after experienced a temperature excursion (Product storage error) of 5.7 Fahrenheit degree during 30 minutes with a previous temperature excursion of 6 to 14 (9.1F) Fahrenheit degree for 1 hour and 6 minutes. No additional adverse event was reported (no adverse event).
Patient received 2nd rotateq dose at 12 months instead of at 8 months. Provider notified and no adverse event occurred.
redness and swelling - treated at urgent care with bactrim ds bid for 7 days
I started having  very increased aches and pains in all my joints that already have been diagnosed with arthritis.  No other symptoms of illness
consumer received MENQUADFI instead of Bexsero with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who received menquadfi (MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE) instead of bexsero with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a dose of 0.5 ml of  suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7450AB, expiration date: 10-Oct-2024 via intramuscular route in the right upper arm as immunization.  On 15-SEP-2022 the patient received menquadfi instead of bexsero with no reported adverse event (wrong product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. Caller reported that the consumer has already had their booster Meningococcal (Groups A, C, Y, W) Conjugate Vaccine with MENACTRA back, on 27Jul2022  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (consumer received MENQUADFI instead of Bexsero with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Blotchiness on arm within a few hours after immz. Fever same night of 102.0 degrees. Fluttering in chest next day. Developed headache. Developed bruising at injection site.
Post vax pt developed an injection site reaction characterized by redness, warmth, and pain. He was seen by MD who made a diagnosis of cellulitis and prescribed dicloxacillin. The pt recovered. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Imune 23 lot 468-484.