chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report concerning a patient of an unknown gender and age was received from a physician via company representative. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, route, frequency, lot and expiration date were not provided) and then, on an unknown date, was vaccinated with GARDASIL (strength, dose, route, frequency, lot and expiration date were not provided) (interchange of vaccine products). No concomitant medications and adverse events were reported. No product quality complain was involved. Additional information has been requested.
At 8:20 AM she complained of tongue swelling, Facial Flushing, BP went up 174/112, Pulse 123, Used albuterol inhaler, Benadryl 50 MG PO, Vitals Signs gradually returned to normal BP on discharge 122/87, Discharged to coworkers at 9AM.
Neck Pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain) and HEADACHE (Headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NECK PAIN (Neck Pain) and HEADACHE (Headache). At the time of the report, NECK PAIN (Neck Pain) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Administration error: Pt. was younger than the age authorized for Janssen vaccine. Pt. had no adverse reaction to the vaccine.
No adverse event, patient received Sinopharm vaccine outside of country and came into clinic for booster. Patient received Moderna as booster, not the recommended pfizer dose for boosters for regulatory authority approved vaccines.  No issue with patient receiving vaccine.
4 days after MENACTRA vaccine noticed one hive at site of shot. lasted 3 days. BENADRYL given on Sun and Mon. No other symptoms. No fever. No rash.
RASH ON STOMACH TO BACK WHICH LOOKED LIKE PRICKLY HEAT; VERY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. The patient received macitentan (tablet, route of admin not reported, batch number: Unknown) 10 mg, every 1 day, from 2019, frequency was not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 20-NOV-2021, the patient experienced very tired. On 21-NOV-2021, the patient experienced rash on stomach to back which looked like prickly heat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The patient recovered from very tired on 20-NOV-2021, and was recovering from rash on stomach to back which looked like prickly heat. This report was non-serious.
My symptoms started between 2-3 weeks after I received the FLUZONE shot. It started with an itchy shoulder blade where it felt like a tag from my shirt was picking at it. It was like that for about a week then I scratched it, it would be painful to touch that area and the pain would radiate around to the front in my left breast area. The itching and picking continued until on December 1st, 2011, I woke up with a weak left leg (the two previous weeks my left leg got very restless and jumpy feeling). On December 2nd my left foot was dragging and I went to see my general family doctor. She got me in for MRI same day. On Monday, December 5th, after getting numb from the chest down during the weekend, and receiving call with MRI results that showed demyelination of spine between shoulder blades on my spine (between T3-T4 area), I was scheduled for two more MRIs on December 6th. I continued to get worse, had tight band feeling wrapping around my chest and I could not walk well by myself so after MRIs were done on the 6th I admitted myself to ER. I spent 3 days receiving high doses of steroids while I was there. At the time of release they didn't know what was wrong, spinal tap showed no infections or anything abnormal. They thought possible MS but they didn't know. In mid-December I saw Neurologist and he gave diagnose of Transverse Myelitis. After I got off first round of steroids my spine swelled up again and on December 23rd went to ER again because I couldn't urinate or walk well. Again got started on prednisone for a longer period of time. Urinary and bowel retention was an issue during this time. When 2nd does of prednisone was finished at the end of January in 2012 I was not better and could not walk well without use of cane or having assistance of another person. In February I entered hospital for plasma exchange treatment for 10 days because I was still numb from chest down, could not walk well, and my left arm as well as both legs were very weak (my left side much worse than right side). I can now walk well by myself without using a cane and returned to work on March 1st. I am not numb anymore but the numbness was replaced by severe pain in my back and chest and burning of right leg constantly. I have had two spinal taps, both showing nothing that proves an infection. I have had several autoimmune tests and nothing was positive. All blood tests were negative for infections, and have no abnormal blood counts. MRI for brain lesions negative. Only one MRI showed lesion on spine that caused nerve damage. I still have bladder issues, sexual dysfunction, cannot sleep at night, extreme pain.
09/26: Sore inject site; 09/29: Increased muscle and joint soreness; 10/05: Combative, argumentive, headache, T99-100, begged to stop tx to MD, who encouraged completion of Rx.  10/17: Stomach burning, no appetitie.  10/30: Continued gi sx joint pain. 11/16: States she feels she is returning to normal.
No adverse effects; 12 month old patient received PROQUAD and VARIVAX on 30-MAR-2019; This spontaneous report was received from a medical assistant regarding a 12-month-old patient of unknow gender. The patient's concurrent conditions, historical conditions and past drugs were unknown. Concomitant therapy included sterile diluent. On 30-MAR-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Albumin status: recombinant Human albumin (rHA)) (strength, dose, frequency were not provided) (lot # R007684 and expiration date 11-SEP-2019) subcutaneously (defaulted route) for prophylaxis and on the same day, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency were not provided, lot # R010466, expiration date 10-APR-2020) subcutaneously (defaulted route) for prophylaxis (inappropriate schedule of product administration). No adverse effects (no adverse event) were reported. No product quality complaint involved.
swelling @ inject site; high fever prolonged (14 days+) @ times above 105; irritable, loss of appetite & weight; rash on face neck, chest & back x 2 days; condition improved p/onset of rash;
Patient reported to pharmacy that she felt "sick to her stomach" and had chills the day after receiving first dose of SHINGRIX and also reported developing a fever blister on outside of mouth (corner of lip). Stated that she has never had a fever blister before.
Information has been received from a 65 year old male consumer with no known allergies and a history of  heart attack in August 2006, who on 02 Nov 2006 was vaccinated with a dose of Zostavax. Concomitant therapy included unspecified "heart medication." On 04  Nov 2006 the patient went to the emergency room because he was having severe pain in his hands and shoulder. The patient was given acetaminophen (+) Vicodin, unspecified blood work was done, and x-rays of his shoulder and hand were done (results not reported). The patient was sent home from the emergency room after 4 hours. On the following Monday or Tuesday the patient saw his physician  who told him to take Advil or Tylenol. At the time of the report the patient continued to have pain in his hand and shoulders, and swelling in his hands and wrist. The patient was also complaining of pain at the injection site when  it is pressed, however he did not have any redness or swelling at the site. The patient was reported to be recovering on therapy. There was no product quality complaint involved. No furter information was provided. Additional information has been requested.
pt recv vax in 1995 & recv MMR in late AUG1995;approx 2 wk p/vax w/varicella,pt devel monoarticular arthritis;lab eval revealed WBC 2500 in joint & an unspecified culture was neg;no further details were provided;
After throwing up at 24 hours and 36 hours after the initial vaccine, there were no reactions until 10 days later. At that point, hives appeared at random on his hands and feet. After giving benadryl, the hives went away. They reappeared on the 12th day after the vaccine, and again, after benadryl, the hives went away.
Chills, fever (never over 100.5), vomiting every 15 minutes from 2:30am 3/13/2021 through 2:30pm 3/13/2021, extreme tiredness through Wednesday morning.
Mental confusion-memory loss. Nausea/vomiting. Rt sided facial paralysis. 6 -> 12 hrs til onset. Increased WBC.
Covid ?arm ?5 inch large red blotch , painful  , swollen, hot, (itchy to start with),  appeared on day seven now on day 8,  continues to spread.
Soreness of Arm, Swelling, Redness.  No Fever.  Went to physician's office.  She was diagnosed with Cellulitis.
Post second dose this pt's right ear became plugged and remained plugged for six weeks. His family physician said it was a cold. A specialist said that his ear was inflamed and prescribed antibiotics(nos) and decongestant(nos) which did not help. Since then, his ear became plugged from time to time and was relieved by blowing air through his nose. The most recent information received 04/26 reports the condition as ongoing.
Generalized hives on trunk, arms, and legs 15 minutes following injection of ZOSTAVAX. Not listed as a side effect-only hives at injection site. Chills and headache -listed as a possible side effect.
Fever at 102 degrees. Local erythema/swelling/tenderness with itching no abscess.
Patient was mistakenly given a dose of 0.5 mL instead of the protocol dose of 0.25 mL for the Moderna booster. The patient's family has been informed. The Long-Term Care facility at which the patient is residing has been notified and is monitoring the patient for adverse reactions. We have contacted Moderna as well, who have instructed us that the only risk we should expect is a slight increased chance in the normally observed vaccine-related side-effects.
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:07 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 30-Mar-2021, Excursion time was 9 AM, temp was 33 , total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was stored on cooler 1 , on 30-Mar-2021, Excursion duration At 9 AM: 33, 10 AM: 36, 11 AM:36, 12 AM:40, 1PM : 40, 2 PM : 39, 3 PM: 38, 4 PM: 40 and 5 PM : 40.  Vials only punctured right before administration  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
I took patient on 11/28/08 to receive the second part of her flu shot and the MMR shot.  (The manufacturer, lot# and any other information is not listed on her shot records form for the Flu Vaccine for whatever mysterious reason).  On December 5, 2008, I took her to facility and saw Dr. because I thought she may have an ear infection.  Both ears were in fact infected and she was prescribed Amoxicillin which she started taking that day. Every other time she has had an ear infection, she improved significantly from the antibiotics within 24 hours.  By Sunday, she was still not showing any signs of improvement and was acting very out of character.  She is a very active baby and was walking but was very fatigued and we knew she did not feel well.  Instead of sending her to her regular babysitter on Monday, I decided to let her stay with her Grandmother so she could get good rest. I called facility and told them that the Amoxicillin was not working and asked if they would call in something different.  They said no and to wait three more days and if there was no improvement, then bring her back in.  At 12:30 p.m. that same day my mother in law called me and said that patient was dragging all day and would not walk and was very sleepy.  At 4:30 p.m. she called me back and said something was wrong with the baby and that she had had a seizure and the ambulance was taking her to hospital.  Please note that patient DID NOT have a fever.  She had not had one since Friday, December 5, 2008 and it was a very low grade temperature of 99.  When I got to the ER, patient was very out of sorts and not acting like my baby at all.  Out of control crying and screaming, throwing her body around and literally inconsolable.  Finally, after a couple of hours, she was finally winding down and to my surprise as I was rocking her, she had another seizure.  She had two to follow within 24 hours.  In all she had four seizures within 24 hours.  Every test you can think of was performed (EEG's including one for 48 hours, MRI, Spinal Tap, blood work, etc.) and they all came back clear.  After the 24 hour period she did not have another seizure and to date has not had another.  Dr. diagnosed her with epilepsy and put her on Trileptal.  I am in the process of taking her off of it because I am not sure that she now has epilepsy and do not want to medicate my child unnecessarily.  If she has another seizure when we take her off of it then we will cross that bridge when we get to it but I do not think that she will.  I truly believe that this was an adverse reaction to the MMR shot and possibly the flu vaccine as well.  All the doctors tell me no, but I do not believe that to be true.  I feel that this combination of shots is too much for these little ones to handle and she will NEVER again get the MMR booster.  Something is terribly wrong with that shot and no one believes the thousands of parents who have sat and watched this happen to their children. Must we put them all on unnecessary drugs and give them bogus diagnoses, or watch horrific or even fatal results before the government does something about it?  I will be very proactive about this.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old female patient, who had no known drug allergies and no illness at time of vaccination. This report referred to a 17-year old female patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported, on 04-FEB-2014 at 12:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
PATIENT RECIVED THE FIRST MODERNA VACCINE , WAS OBSERVED FOR 15 MINUTES.  AT 25 MINUTES PATIENT REPORTS FEELING HOT , FLUSHED , TONGUE AND LIPS FELT SLIGHTLY SWOLLEN AND TINGLING , PROGRESSING TO SWELLING AND TINGLING OF FACE . SHE WAS EVALUATED BY RN AND MD . SHE RECVIED 50MG OF DIPHENHYDRAMINE BY INJECTION . SYMPTOMS IMPROVED OVER THE NEXT 30 MINUTES.
pt recv vax 20APR98 & was found to be a nonresponder on 19JUN98;
FLUMIST and VARIVAX vaccine were administered. Pt c/o chest pain at home. Pt returned to office, BP was taken and was monitored. c/o rash on body and itchy hands.
Voiced metallic taste/nausea.  Inintal compliant began @ 1340.  Left observation @ 1400.  Denies any other s/s of distress.  No SOB/Trouble breathing as well.
On 12/7 patient came in for a flu vaccine appointment. Fluarix is currently the only available flu vaccine that we have in stock for her age range so it was chosen for the vaccination. In the vaccination room patient informed me that she had a new egg allergy and that she didn't think it would be an issue. I informed her that the vaccine she was signed up to get was not one of the available egg-free vaccines and that I did not have any egg-free vaccines in stock. I informed patient that with her egg allergy she could still receive the vaccine as studies have shown that a reaction is unlikely however that she may benefit by having the vaccine done at her PCP's office where they have more supplies to treat her in case of a reaction. Patient elected to have the vaccination in store opposed to waiting.  Within minutes of receiving the vaccine she began clearing her throat and coughing. Upon questioning she said that she was experiencing tickling in her throat. As her symptoms progressed over the next minute she began coughing more and wheezing. I asked her if I could administer  an epipen and called emergency services to which she declined and asked for Benadryl stating that it worked to treat her symptoms. I told her that I was unable to give her oral Benadryl but would need to administer it in another shot. At this time patient was still coughing, wheezing, and experiencing tingling in her throat but she stated she was not sure how much of it was the reaction or her panic in response to it. within about 3 minutes of administering 50mg of diphenhydramine patient was calming down and leaving her with just the tickle and cough. Patient remained in our vaccine room for ~15 minutes and then remained in our waiting area for another 15 minutes before stating that she felt good to leave. Roughly two hours later I performed a follow up call with patient to ensure she was feeling better.
herpes zoster; other zoster related injuries; This spontaneous report was received from a patient of unknown age and gender regarding a case in litigation on 18-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about February 2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for the long-term prevention of shingles and zoster related conditions. Subsequently, the patient was treated by a physician for the following injuries herpes zoster and other zoster related injuries. At the reporting time, the outcome of herpes zoster and zoster related conditions was not provided. The reporter considered the event herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
PATIENT SUFFERED NO ADR.  HOWEVER, PATIENT REPORTED ON DAY 28  (RIGHT BEFORE HER SECOND DOSE) THAT SHE  IS 17 Y/O AND THOUGHT SHE WAS GETTING  PFIZER COVID-19 VACCINE.
Low grade fever 100.8 and headache approximately 4 hours after injection. Ibuprofen 200mg x1 and symptoms  abated. Third day following injection itching, redness and warmth at site. Area approx. 4? in diameter. No other symptoms at present.