chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M032493 and expiration date of 06-JUL-2018 for prophylaxis (dose and route of administration were not reported). The vaccine was exposed to a temperature excursion of 15°F to 46°F with a time frame of 17 hours and 4 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. The digital data logger was involved in the temperature excursion measurement. This is a non-valid case due to the lack of patient identifier. Follow-up information has been received from a registered nurse on 31-MAY-2018. The details of on of the vaccinated patient were updated. The patient was male, he was 15 years old. On 08-MAY-2018, the patient was vaccinated with his second dose of VARIVAX, subcutaneously, in the right arm, lot # M032493 and expiration date: 06-JUL-2018. The vaccine was improperly stored in a clinical practice. There was no adverse event. The patient did not seek any prescription drug treatment.
Pt states she had a rash all over her body for the first three days after the injection. Then the rash went away and she had itching all over for three days. Patient treated with Benadryl, Zyrtec and Atarax.
Eyes swelled within 10 minutes of vaccine. Continued to swell. Hard to see. Told to drive home and if I couldn't see to pull over and dial 911. I had taken a benedryl before getting the vaccine. They told me to take another one. Didn't have them with me. I drove to store and bought some. Called a friend to meet me. I could hardly see by t hen. Waited for the benedryl to work before driving home. My asthma acted up and I had to use my inhaler. Also eyes kept swelling back up for next 2 days. I continued benedryl to get the swelling down. Also had muscle/joint pain all over similar to a fibromyalgia flare up. Lost my sense of smell.
Patient received PNEUMOVAX vaccine and after 2 days has pain, spreading redness, and swelling. The reaction was caused by the PNEUMOVAX vaccine and not the FLUZONE.
After his booster on 2/23/21 he had joint pain that made it hard to work and swelling behind the left knee. It was so stiff he could not bend his leg. Also restless leg.
fever to 103 & two gen sz w/in 24hr of vax;fever to 102.5 w/sz 9 days p/vax;
Headache, Arthralgia, numbness/tingling in extremeties, subjective fever in evening Narrative:
Severe chills and a slight fever for about 5 hours.  Bundled up and stayed in bed till chills stopped.
FIRST VOMITING, THEN PALE YELLOW LOOSE STOOLS, LOSS OF APPETITIE, FUSSINESS, LESS ACTIVE. MOTHER PLANS TO TAKE SON TO DOCTOR.
T/C from mother, child has small lump with erythema in size of quarter; low grade fever (states sweating, hasn't taken temp) and has been crying since this AM.
Pt broke out in bright red, flat blotch like rash approximately 6 hours after vaccinations.  Pt had urticarial rash.  Treatment: benadryl.
PATIENT PREVIOUSLY RECIEVED 1 DOSE OF PFIZER VACCINE (2/23/2021-LOT EM9809)
This spontaneous report as received from a 60 years old female patient with high blood pressure and drug reactions/allergies to amlodipine besylate and ace inhibitors referred to herself. The patient was vaccinated with a dose of live ZOSTAVAX (1 time vaccine, subcutaneous, lot#, dose were unspecified) on 25-JAN-2013. Concomitant medications included atenolol, TENORETIC, CRESTOR and PRILOSEC. The consumer stated 24 hours after receiving the vaccine(26-JAN-2013), she had a headache, runny nose,with no symptoms, cold sores on her lip on the right side, and 1 in the middle of her upper lip. She stated she also had pain at the injection site right after the injection. She would contact her physician. She also stated it was cold sores, with open blisters. Patient did not seek medical attention. No lab diagnostics studies performed and no treatment was given for events. At the time of reporting, the outcome of event were unknown. The relatedness for all events were unknown for live ZOSTAVAX. Additional information has been requested.
Is Cancer Yes; tested positive for HPV since vaccination; unspecified HPV vaccine; This spontaneous report has been received from a physician assistant (also reported as physician, conflicting information) referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were unknown.   On unknown dates, the patient was vaccinated with a complete series of an unspecified human papillomavirus (HPV) vaccine injection (route reported as injection; strength, dose, lot number and expiration date were not known) as protection against HPV (product origin unknown).  On an unknown date since vaccination, the patient was tested positive for HPV. It was also reported as a cancer event (neoplasm malignant). The patient sought medical attention and was requesting additional vaccinations with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was unknown if any treatment was given. At time of reporting, the outcome of the event was unknown. The causality between unspecified HPV vaccine and the event was not reported. The reporter stated that their electronic medical record (EMR) was down at this time, so she was unable to provide exact vaccine name, patient's age and all additional information. No product quality complaint (PQC).   Upon internal review, the event of neoplasm malignant was determined to be medically significant.
10 minutes after the shot my muscles begin to tighten up and my sciatic started hurting I couldn?t move my legs and now my muscles are stiff all my joints hurt.
No adverse events at time of vaccination. After vaccination pt discovered she is pregnant LMP 9-10-11.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient turned purple and green in the face and then fainted.  Choked and then came to, laid flat and elevated legs until ENT arrived.  Pt stayed seated for a while and then was feeling better.
was administered and one of the vials was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA379A, expiry date 31st July 2022) and (batch number AMAA379A, expiry date 31st August 2021) for prophylaxis.   On 16th December 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 16th December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy technician reported that, the nurse at the clinic administered Menveo vaccine noticed after the vaccine was administered that one of the vials was expired, which led to expired vaccine used. The reporter wanted to know if any adverse events have been reported after an expired Menveo vaccine was administered. The reporter did not have outer carton at the time of reporting.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA011253.
PATIENT HAD SEVERE LOW BACK PAIN FOR BOTH DOSES OF SHINGLES VACCINE, "IT WAS LIKE GOING THROUGH LABOR". SELF LIMITING, RESOLVED IN A FEW DAYS. HAPPENED ABOUT 24 HOURS AFTER VACCINE  AND RESOLVED WITHIN 4 DAYS.
No adverse effect reported; Route of Administration:  intramuscular in "right upper outer gluteal muscle"; This spontaneous report was received from a nurse, concerning a male patient between 11-12-year-old. His pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   In approximately October 2019 (also reported as "about 3 month ago"), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), intramuscular, right upper outer gluteal muscle (product administered at inappropriate site) (strength, dose, lot number and expiration date were not reported).  No adverse effects reported from that first dose.
Dizzy; Extreme exhaustion; Abnormal fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 19Apr2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, migraine and celiac disease. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and fish oil (OMEGA 3); all for an unknown indication from an unknown date  and unknown if ongoing. On an unknown date in Mar2021 (also reported at 16:30), the patient experienced dizzy, extreme exhaustion and abnormal fast heartbeat while doing simple things like walking up a flight of stairs. The patient used to work out all of the time and do CrossFit. This exhaustion, fast heartbeat and dizziness was abnormal for the patient. It started after the first dose of vaccine. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, extreme exhaustion and abnormal fast heartbeat were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
One day after receiving 4 month vaccines DTaP 2, IPV 2, HIB 2, prevnar 2 broke out in tini macular erythema on face arms legs and abdomen. the next day. 2 dyas after vaccines rash is now large erythematous macules on face arms legs, chest and abdomen. Chid is breast fed and had been receiving Tylenol drops. Went to ER TX with Prelone syrup and Benadryl. 5 days later rash is much less, comes and goes. No fever, smiling cooing for duration.
ADULT OBSTRUCTIVE SLEEP APNEA 4/3/2023 OSTEOARTHRITIS OF BILAT SHOULDERS
This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 04-NOV-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and/or M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, sterile diluent (MERCK STERILE DILUENT) used to reconstitute vaccines was expired. The reporter stated that, it was unknown whether the patient received MMR II or VARIVAX separately or MMR II concomitant with VARIVAX. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
Afib issues; Heart rate would increase and decrease; Feeling really tired; woke up really dizzy; A spontaneous report was received from a Consumer concerning herself, a 68- year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, afib issues, heart rate would increase and decrease, feeling really tired, and severe dizziness like vertigo,   The patient's medical history, as provided by the reporter included, Afib and underwent surgery on 13 Jan 2021 for Afib issues. Concomitant products were not reported.  On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, it was reported that the patient experienced the events, Afib issues, heart rate would increase and decrease, went to bed feeling really tired and woke up with severe dizziness like vertigo, heart was down in the 40s and then spike up to the 80s. The patient was concerned that vaccine may have triggered Afib.   On 19 Feb 2021, the lab test performed included heart rate 40s, heart rate 80s.  No treatment information was provided.     Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of events, Afib issues, heart rate would increase and decrease, feeling really tired and severe dizziness was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the events and excluding all other etiologies, a causal relationship with the events cannot be excluded.  However, causality for Afib issues is confounded by the patient concurrent history of Afib. Fatigue is consistent with the known safety profile of the vaccine.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an adolescent female patient (his daughter) of an unspecified age, race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced migraine headaches, she felt sick, nauseous and she had neck pain. The patient recovered after a couple of days of rest. No follow-up attempts are possible. No further information is expected.
I had body ache, sore throat, and cough. I was very, very tired. I had a headache and fever that comes and goes. It feels like cold like symptoms. I went on Jan 5th to get tested for COVDI-19, positive result. I also did a rapid Covid-19 test, negative on that.
Patient experiencing legs numbness upto the knee.  Symptom occurred about 5 mins after receiving vaccine
Three days after receiving patient experiences a whole body reaction while on treadmill. Severe urticaria, hives. rash welts
I had the vaccine in April but on 6/23/2022 I had a cataract surgery on my right eye, it went fine until Monday 6/27 evening that I had little tiny points vision, I called the doctor, and I went for an appointment, he dilated the eye, check to see if there any blood; doctor gave me eye drops to take for 1 month and almost done with the drops. Next appointment is August 8th, 2022. Doctor does not know why I had the tiny points in my vision. I also had a cataract surgery on my left eye on 6/30 with no problem.
Patient ran a fever of over 104 degrees. There were great shaking and trembling of his body. We were still in front of doctor's office. Mother went back inside doctor office and doctor told mother that you don't get a fever from the chicken pox shot. She gave us some Tylenol and said to alternate it with Motrin until the fever go away. Fever did no go away. As the days went by patient started to wheeze and was given steroid (liquid). Patient was later diagnosed with transient hypogammaglobulinemia of infancy. Patient stopped talking and was very sickly for more than a year. Patient never spoke again. He was diagnosed at age 32 months with PDD/NOS.. Medical records state tonsillitis. msv
VIAL 1 WAS NOT MIXED WITH VIAL 2. PATIENT ONLY RECIEVED CONTENT OF VIAL 1.
Initial report received from a health care professional (nurse) on 01 Mar 2011: On 01 Mar 2011, this patient was vaccinated with only the MenCYW-135 liquid conjugate component of MENVEO (batch number: M10029), intramuscularly without being reconstituted with the MenA conjugate component. No adverse events were noted following this administration. Follow up report received from a health care professional (nurse) on 08 Mar 2011. Patient demographics updated.
congestion, difficult breathing, h/a, sinus, diarrhea, fatigue, sore, depression, palpation of blood vessels, phlegm, flu sx, chills;
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 7 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received the newest version of the shingles shots. 7 months after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Arm itchy @ injection site. Then little bumps came up with 2 large bumps  that have white centers. Extremely itchy currently. Pt has been putting hydrocortisone on the site. Took Benadryl orally 1 dose on 11/13/2009.
Information was received from a nurse concerning a first grade student who on 21 MAY 1998 was vaccinated with a dose of Varicella.  On 17 DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the first grade student.  No product quality complaint was involved.  Additional information was requested.
the patient's husband reported that around 3am, the patient woke to visual hallucinations that lasted throughout the night. The hallucinations were reported to have stopped around 8am on 2/25/21. the patient does report remembering most of her hallucinations.
Approximately 5 hours after vaccine administration my right arm and right armpit were mildly sore, I had mild nausea. 18 hours later soreness in right armpit and right arm (injection site) increased, nausea increased I vomited 3 times (dry heaves), body achiness, mild fever 99.9 (my normal temperature is 97.4, fatigue. Swollen lymph node in right armpit.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, UNSPECIFIED
Vaccine stored beyond use date given by Moderna.  Moderna ran an analysis and reported: The vaccine administered on October 13, 2021, October 14, 2021 and October 19, 2021 from lot number 020F21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration; however, some vaccine may have activity below the level studied in our clinical trials.
Considerable Elevated liver enzymes in blood lanel-  ot sure if related  to vaccine or not
approx 4-5 days p/vax pt had an indurated swelling @ the site of vax lt upper arm; area of urticaria extended away from site; very pruritic; fever 101; treated w/warm soaks & DPH as well as NSAID's;
Three days after receiving the Moderna booster I experienced an elevated heart rate. I went to my primary care physician, who administered an EKG test, and my heart rate was between 145 and 150. My PCP sent me to the ER for further tests. I went to the  emergency department in state. There I received multiple labs and tests. I received a low-dose beta blocker, low-dose anti-anxiety medication, and some magnesium (since my lab results concluded I was low in magnesium). I now I?m wearing a Zio patch for two weeks, and I will see a cardiologist on December 22.  I have a family history of afib. However, I have not previously experienced symptoms myself. I am taking a low-dose beta blocker and low-dose aspirin now.
Injection site soreness,  Fever 101, body aches - both aches and fever lessened with Tylenol
Patient was administered booster Pfizer dose before 6 months had elapsed since her second (AstraZeneca) dose received in (Privacy) on 10/12/21. Patient waited for more than 30 minutes and had no adverse reactions.
Large area of erythema and swelling. Three days after the vaccine it's 11 x 16 cm.
This spontaneous case reported by a consumer, describes the occurrence of back pain (pain moved to part of right-side of back), pain in extremity (pain in right hand/pain moved to the whole arm) and arthralgia (pain moved to shoulder) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. April 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 20, 2021, patient experienced pain in extremity (pain in right hand/pain moved to the whole arm). On Jun 23, 2021, patient experienced back pain (pain moved to part of right-side of back) and arthralgia (pain moved to shoulder). At the time of the report, back pain (pain moved to part of right-side of back), pain in extremity (pain in right hand/pain moved to the whole arm) and arthralgia (pain moved to shoulder) outcome: unknown. No concomitant medication or treatment information provided.
This is an 86 year old female, , with past medical history significant for Atrial fibrillation, s/p PPM, Hypertension, Hypothyroidism, DM type 2, non-insulin dependent, Dementia, Anxiety, who initially presented to the Emergency Room this AM for monclonal antibodies post exposure. The patient is a resident where there is currently a covid outbreak. She received her MABs and was transported back to the facility. On arrival to the facility, the patient vomited and 02 sats were 76% on room air therefor she was sent back. A CXR was negative for an infiltrate and showed possible Cardiomegaly.