chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-healthcare professional on 3 November 2015. The case involves a 60-year-old female patient who was vaccinated with a dose of Adacel (batch number, expiration date, dose, dose number, route and site of administration were not reported) and a dose of Pneumovax (batch number, expiration date, dose, dose number, route and site of administration were not reported) both intramuscularly on 22 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Illness at time of vaccination was unknown. Concomitant medical was not reported. On 22 October 2015, three day following the vaccination, the patient experienced cellulitis at the injection site, a red area around the injection site about 12cm in size, hot to touch, central induration size of half a ping pong ball. The patient required ER or doctor visit. Laboratory investigation was not reported. The patient received Keflex as corrective treatment. The patient was on day 10 of Keflex. The outcome of the event was unknown. Follow-up information received from a non-healthcare professional on 28 December 2015. This case involves a 50 years old patient who was vaccinated at private doctor's hospital. On an unknown date, the patient was recovered from all the events. Documents held by sender: none. Follow-up information received from a non-healthcare professional in the United States on 13 January 2016. Batch number and expiry date of Adacel was reported as U5235AA and 08-Jan-2018. Patient received Adacel in upper left arm and pneumonia shot in right upper arm. It was reported that four days prior to vaccination patient was on four day course of prednisone to treat asthma flare up. On 25 October 2015, patient arm was sore and nurse stated that it looked like cellulitis and was diagnosed. Patient was prescribed antibiotic for 10 days. The patient did not require any ER visit. On 26 October 2015, patient went to saw primary care person who had confirmed cellulitis. It was reported that redness subsided within 10 days and induration took nearly a month to go away. Addendum: upon internal review on 2 February 2016 significant correction was performed, to change sequencing of reporter.
This spontaneous report as received from a licensed practical nurse refers to a 2 month old male patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 15-AUG-2016, the patient was vaccinated with ROTATEQ, 2 ml, orally, lot# M019690, expiry date 02-NOV-2017. On the same date, the patient vomited 3 times. No treatment was given for the adverse event. The outcome of the event was unknown. The patient sought medical attention (no details provided). The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Left shoulder pain; back pain; pain and numbness in left hand/fingers; numbness in left hand/fingers; pain in elbow; pain and numbness in left hand/fingers; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 19Mar2021 at 09:00(at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, allergic to IVP(Intravenous pyelogram) dye, detergents allergy(detergent sensitivity), allergy to legumes and peanut allergy. The patient received medications(unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 08:00, the patient experienced left shoulder, back pain, pain in elbow, pain and numbness in left hand/fingers. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received naproxen and tizanidine as the treatment for the reported events. The clinical outcome of the events left shoulder, back pain, pain in elbow, pain and numbness in left hand/fingers were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt admitted with acute pleuritic CP and dyspnea that started the day after vaccination. Found to have bilateral PE
Allergic reaction, my trachea closed! After a few seconds I was able to slowly catch my breath. The one who injected me only offered me alcohol to breathe. They did not give me any medication.
Patient was unknowingly given Booster Dose with expired vaccine.  Patient was contacted by his provider once the error was realized
Immediate soreness, swelling and pain at the sight of the injection that lasted for over a week. Discoloration that is round at the sight of the injection . The same sized that developed right after the injection of the 1st dose of Shingles and has not gone away.
5 days after her 2nd moderna covid vaccine shot, my mother was walking to her camper, and her knee "gave out." She has never had any pain or other problems with her knee prior to this moment. She did not sustain any falls or injuries before or after the immediate onset of knee pain.  Since her knee gave out, she has had severe knee pain, swelling, and has been unable to ambulate well. She went to see an orthopedist, who did an MRI and diagnosed her with "arthritis." She has had to have fluid removed from the knee twice. She also developed shingles on her forehead 4/1/2021, 8 days after her 2nd dose of vaccine.
On Wednesday, the week after the vaccine, it was itching , burning and turned pink.  On Thurs, I marked my arm. On Friday it  had grown  in size and was hot to the touch , itchy and swollen so I went to UC to be seen.  I was prescribed an antibiotic for one week and advised to take pepcid. Within 36 hours of taking the antibiotic, my arm was totally back to normal.
PATIENT HAD VASOVAGAL SYNCOPE FOR 10 SECONDS AFTER GETTING THE SECOND COVID MODERNA VACCINE. PATIENT IS VERY SENSITIVE TO THE SIGHT OF NEEDLE AND FAINTED FOR FIVE TO TEN SECONDS
This spontaneous report as received from a healthcare worker refers to a 65 year old patient. On 02-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H011780, exp. date 16-FEB-2014) (dose and route not reported), that was expired. The dose of PNEUMOVAX 23 had not been exposed to any temperature excursions, and the patient had never received a dose of PNEUMOVAX 23 in the past. No adverse effect has been observed or reported. Additional information has been requested.
Developed rash, fever 5 days after vaccine. Vomit started 7 days after vaccine. Fever lasted 8 days. Rash was on back of legs, back of neck, side of head, wrists, & arms.
Received 3 doses of Moderna; Patient came to clinic for Moderna Covid vaccine.  She completed paperwork stating she had NOT received any previous Covid vaccines.  When entering her information into database it was noted that she had already had 2 previous doses of Moderna.  However, the original doses were only 3 weeks apart versus 4 weeks.  Our office contacted the vaccine program and were instructed at that time that patient did NOT need to repeat series.
Admission for Procedures: Left - ARTHROPLASTY TOTAL HIP EXPLORATION/ REVISION OF ARTICULATION, IRRIGATION AND DEBRIDEMENT. Recovered in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
pt recv vax 29APR97 & stated area was sore the next day but on may 1st had bruising, heat & edema @ site;
injection unremarkable, slept deeply that night, woke up feeling well but as day progressed i afternoon I developed severe chills, could not get warm, headache, body ache, and later fever of 102.5 Slept on and on for 15 hours  taking advil pm every 4 to 5 hours. Woke up next day feeling well.
Severe lethargy, confusion, dehydration 12/2-3. Low oxygen saturation of 78% on 12/4 and increased confusion along with nausea, vomiting, diarrhea. .
There is no adverse event but this is considered a vaccine administration error due to the lack of information given to us when the dosing changed with the removal of the monovalent vaccine. We did not receive any updated dosing instructions until this week which did not give clear or apparent directions involving change in vials and age indications. There should have been a complete halt in vaccinating until clear and concise instructions were made available to the healthcare industry. Clear and concise does not mean sifting through 72 pages and clicking on multiple links to find the needle in the haystack.  Now we have a vaccination error due to the lack of information from those in charge who dropped the ball. We take no fault in this error. This patient should have received the blue cap gray label bivalent but received the yellow label pink top bivalent. (who uses these descriptions to clearly instruct people on what to do?) This is unsafe and unclear. You also assume that we have knowledge of all the vials and different formulations out there when we don't. You totally dropped the ball and this error rests on those who make the rules and instructions. Parents dont have faith in vaccines anymore and this error does not help.
Had two reoccurrences since the vaccines/Suspected vaccination failure; Had two reocurrences; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles off and on for about 12 years).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient took both Shingrix shots and had two reoccurrences since the vaccines. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough) and DYSPNOEA (Major breathing issues/Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Neurological) in November 2020.Concurrent medical conditions included Asthma (asthma attack once a year.) and Wolff-Parkinson-White syndrome (not medicated). On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced PULMONARY CALCIFICATION (Calcified nodule of lung). On an unknown date, the patient experienced HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), CHEST DISCOMFORT (Chest congestion), LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Broke fever in pool of sweat for 4 nights which kept getting worse), HEAD DISCOMFORT (Massive pressure in head), INSOMNIA (Insomnia), COUGH (Developed a cold cough), DYSPNOEA (Major breathing issues/Shortness of breath), PULMONARY CALCIFICATION (Calcified nodule of lung), CHEST DISCOMFORT (Chest congestion), PYREXIA (Fever), CHILLS (Hot chills), HEADACHE (Headaches) and FATIGUE (Fatigued) outcome was unknown and LOWER RESPIRATORY TRACT INFECTION (Chest cold for 14 day) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 03-Jan-2022, Chest X-ray: abnormal (abnormal) calcified nodule of lung.On 14-Jan-2022, Computerised tomogram: results not reported at 04:30 pm , Results not reported.On an unknown date, Blood test: results not reported Results not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included inhaler(unspecified). Treatment medications also included nebulizer (5 times a day) and inhaler(not specified.) Patient stated she would be going to a cardiologist and pulmonologist on the day of reporting.
patient received dose #2, then had a total of 5 ED visits for dyspnea and other symptoms including overnight admission.  patient with bilateral, sub segmental pulmonary emboli.  no prior history of PE, is a long distance runner.  received at outreach clinic due to being a teacher
Strong headache, nausea, muscle pain, joints pain, dizziness, chest pain, feel very thirsty, chills, fever,sore throat , fatigue, itching all over my body . The headache was very strong to me , Iam afraid to have the second dose next month
Pt recvd vax & awoke from nap @ 445Pm screaming w/fever to 101, shaking chills, vomited 6 times; treated w/APAP; temp inc to 102.6 by 535PM; pt was seen in ER & was dx w/viral infect not related to typhoid inject;
Left arm felt tingly then numb immediately after flu vaccine given, then went away in few minutes. This morning woke up with rash/red dots on face and opposite arm (right). No rash on left arm, torso or legs. No facial swell or resp. distress. Give BENADRYL by mouth and went to school.
This spontaneous report was received from a physician referring to a 14 year old female patient, whose medical history and concurrent conditions were not provided. On 16-DEC-2015, the patient was vaccinated with GARDASIL 0.5 ml, intramuscular in the left arm, first dose, lot # K010215, expiration date 05-MAY-2017. Concomitant therapies included ABILIFY. On 16-DEC-2015, 10 minutes after the administration of GARDASIL the patient experienced loss of consciousness, reported as the patient "stood up and passed out". The patient was placed in observation for 45 minutes and was given water and sugar as treatment. At the time of the event the patient was in the physician office. At the time of the report, the outcome of loss of consciousness was reported as recovered on 16-DEC-2015. Additional information has been requested.
Case number PHHY2012US076743 is an initial literature report received on 31 Aug 2012. The intent of the article was to discuss about a standardized algorithm that assist in collecting and interpreting data and that help in assessing the causality after individual adverse events following immunizations and presented the case of a patient who experienced acute disseminated encephalomyelitis following vaccination. This report refers to an 11-year-old male patient. It was reported that he was healthy previously. He was vaccinated with Meningococcal conjugate vaccine (manufacturer and batch number: not reported, hence conservatively taken as Meningococcal vaccine general INN) and tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: not reported) through unspecified route and site on an unknown date. Five weeks after vaccination he developed headache, excessive sleeping and severe neck and back pain. On Cerebrospinal fluid (CSF) analyses, his WBC count was 109 WBC/mm3, protein was 67 mg/dl and glucose was 66 mg/dl. A CT scan of the head was performed which was normal. It was reported that the initial diagnosis was aseptic meningitis. His CSF, urine and blood bacterial cultures were done and yielded no growth. MRI of the brain and spine performed two days later revealed abnormalities consistent with acute disseminated encephalomyelitis (ADEM). It was reported that no viral cultures were obtained and there was no evidence of any other acute infections. The outcome of the event was not reported. The author reported that the causal relationship between the events and suspect vaccine could not be determined (indeterminate). The article was concluded stating that assessing causality in an individual patient was challenging because of the multiple factors that must be taken into consideration and due to the need for careful clinical evaluation and judgment.
The vaccine administered was expired. The manufacturer was contacted and alerted of this event. They performed an analysis of the vial. The manufacturer determined that the vaccine had maintained the necessary activity to protect against COVID-19. Our Medical did not recommend the patient to be vaccinated again taking not consideration the findings from the analysis.
On 6/4/22 I started having a headache and it continued the next day and on 6/6/22 I woke up and noticed my face felt weird and I couldn't close my left eyelid and I thought I slept wrong on my left side and after 15 minutes it did not go away so I went to an urgent care clinic to rule out stroke. They examined me and they could tell it was Bell's Palsy and gave me a prescription for some medication for it and that was prednisone and antiviral. I still have the Bell's Palsy as of today.
49 year old female presents with c/o puffy. Patient presents to clinic c/o swollen eyelids and under eyes, left eye with increased swelling. She reports waking up this morning and eyes were swollen closed and red. Denies itchy, watery eyes, denies fever/chills, no problems breathing. Patient reports she had a PNEUMOVAX 23 injection in left arm yesterday afternoon. Has been taking XYZAL, SINGULAIR, and FLONASE nasal spray. Denies: matting of eye. Discharge. Exposure to conjunctivitis. Visual impairment. Tearing. Eye pain. Photophobia. Dryness. Itching.
This case was reported by a consumer and described the occurrence of autism in a 4 year old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) and Hepatitis B vaccine recombinant (Engerix B).  The reporter is the mother of the pt.  A physician or other health care professional has not verified this report. The pt's past medical history included allergy to beef, casein allergy, celiac aprue and milk allergy.  On an unspecified date, the pt received a dose of Infanrix "in the leg" (dose # not specified). On the same day, the pt received injections of Hepatitis B vaccine recombinant (Engerix-B), measles, mumps and rubella virus vaccine (MMRII) and poliomyelitis virus vaccine (IPOL). Approximately one day post-immunization, on an unspecified date, the pt "started falling down". The consumer reported that, "the next day, he had a rash, the next day he had a seizure and the next day, he had leg swelling in the leg that he received the Infanrix."  At an unspecified time following the administration of Infanrix, the pt was "diagnosed with autism". Autism was ongoing at the time of initial reporting. Falling, rash, seizure and leg swelling resolved. Comment: Autism and seizure were assessed as medically serious by manufacturer. (OMIC). Per follow up report received on 08/19/2005:  Reporter wishes no more contact from GSK.
Patient presented to the hospital on 9/5/21 with worsening dyspnea that had been going on for a month. He tested positive for COVID on 9/5/21. He is currently still hospitalized and on 7L of Oxygen
Right shoulder vaccine injury with pain beginning on 1/28/2021. Vaccine injected too high resulting in Right shoulder and neck pain, spasms  and bursitis. PT, steroids and pain meds.  Treatment ongoing.
1. 3/28/2021  Felt crummy, fatigue, low grade fever (100.7, PM only). All symptoms well controlled with ibuprofen. Felt fine by 3/29/2021 AM. Plus had a sore arm. 2. 3/29/2021  1.5 inch slightly raised, red, itchy swelling surrounding injection site. Used cortisone cream for itch which worked. Has gradually subsided through 4/2/2021.
This case was reported by a pharmacist (also the subject) and described the occurrence of high fever in a 29-year-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). Concurrent medications included Multivitamins. On 10 August 2010 at 09:00 the subject received 2 doses of ENGERIX B pediatric (unknown route, right deltoid) in place of the 3rd dose of ENGERIX B adult in the series. On 10 August 2010, less than one day after vaccination with ENGERIX B pediatric, the subject experienced high fever, joint pain and back pain. At the time of reporting the outcome of the events was unspecified. Follow-up information was received from the reporter on 23 August 2010. The subject was administered 0.5 ml of both ENGERIX B vaccinations intramuscularly. On 10 August 2010, less than one day after vaccination with ENGERIX B pediatric, the subject also experienced fatigue and malaise. The reporter did not consider the high fever, joint pain or back pain to be serious events. The subject was treated with TYLENOL Extra Strength and ADVIL.
9 mos. old infant had vaccines this am and the only different vaccine was the flu. Mom noticed rash on the baby 2 minutes after vaccines given and notified the clerical staff. The clerical staff came and got me to check the baby. There was a flat splotching red discoloration under skin on forehead, back of neck an dface and also on upper chest area. No respiratory distress and the baby was taking his bottle. The rash increased when the baby cried. No respiratory problems noted and once he stopped crying the rash disappeared some what. Dr. notified about the rash and ordered to give the Benadryl. Benadryl 12.5 mg/5cc given orally to infant. Mother given instruction on Benadryl dosages for the next 24 hours and to call 911 if baby developed respiratory distress and to call private physician for follow-up. Infant monitored 12-20 minutes post medication. Rash disappeared.
Moderna was given to the client who was 17 years of age at the time of the initial (01/27/2021) vaccine series was completed (2nd dose - 02/24/2021) in appropriate time (28 days)
Approximately 15 minutes after Janssen Covid19 vaccine administered, Patient reported dizziness to nurse that was monitoring pt post vaccination, nurse stated patient was cold & clammy to touch, pt was crying and reported difficulty breathing. Nurse administered 0.3 mg epinephrine via EpiPen injector. I entered room immediately as epinephrine was being administered by RN.  Patient was sitting in chair, crying, and responding to questions when asked. Nurse assisted me in laying pt on the ground. Patient's arms were jerking significantly, caregiver reported this was more pronounced than usual. Per finger pulse ox: Pulse was 132 bpm, O2 Sat 93%, BP ready to be taken when paramedics arrived at scene and took over.