chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot number L039660 with expiration date 04-FEB-2018, and lot number M020926 with expiration date 11-AUG-2018). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter.
Was monitored for 30 mins and felt lightheaded and weak at the exit table. I was put in wheelchair, moved to a cot, and Paramedics were called.  I was weak, couldn't stand without help  and I felt drugged. I was taken to ER for monitoring and testing for reasons why this occurred. Continued to feel passed out for 2 hours.  Tests for heart attack, diabetes and anemia were negative Diagnoses was Vasovagal attack - sent home after 8 hours monitoring
Started with severe pain in hips joints - had Xrays, just regular arthritis, not enough for this amount of pain.  That slowly cleared up, then severe pain in shoulders, wrists and hands and fingers.  Fingers on right hand swollen, skin peeling.  Pins and needles, and electric shock sensations.  Lost 10 pounds, couldn't sleep, paced the floor at night.  Horrible.  Have seen a neurologist and rheumatologist and have been on two rounds of prednisone.
left leg pain; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient took the Shingrix vaccine and had left leg pain not too bad. The follow-up would not possible as contact information was not available. For tolerance of 2nd dose refer case US2021AMR198918, reported by same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198918:Same patient,second dose
Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves 19 years old male patient who experienced reporting a bump on the head and back pain., while he received vaccines MENACTRA, ADACEL,  TRUMENBA and  HPV VACCINE, The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6207AA and suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE via intramuscular route in the right arm. On 09-Jan-2019, the patient received a dose of suspect HPV VACCINE and TRUMENBA (lot number and Expiry date unknown) via unknown route in the left arm. On 10-Jan-2019, the patient developed a non-serious reporting back pain. (back pain) and bump on his head (peripheral swelling) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HPV VACCINE and TRUMENBA. (Other relevant tests included No lab data.) Final diagnosis was bump on his head and back pain. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. List of documents held by sender: none
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
4 days after second dose of Pfizer vaccine developed raised itchy rash on both arms and some on stomach. Began in the evening. Took some Benadryl and used some triamcinolone cream on itchiest raised areas.  Went away in a couple hours.  Rash returned the next evening about 24 hours later. Had not redosed with antihistamines or anything in between. Again dissipated with Benadryl and a little bit of triamcinolone cream. Took Claritin or Zyrtec doe next 4 days and rash never returned.  Had not done or eaten anything different other than vaccine that could think of. Have not had rash like this before. Also in case important, had fairly strong expected reaction starting about 12 hours after vaccine w that includes fever up to 101.5, chills, myalgia, and headache. Had to have a covid test to go back to work due to fever which was negative. I just haven?t seen a lot of delayed hypersensitivity rashes (presuming thats what is) with Pfizer vaccine so thought would report.
Subsequent to receiving the second dose of varicella virus vaccine live the pt experienced a lack of response. The pt sought unspecified medical treatment. Additional information has been requested.
Fever (subjective) and facial swelling starting the evening after immunizations, No rash, difficulty breathing, swallowing. May have been exposed to measles on April 14.
I had vaccination on 09/09/2022. I had symptoms on 01/20/2023 to include sore throat aching coughing. I tested COVID-19 positive on 01/23/2023. I was prescribed PAXLOVID. I did get rebound COVID-19. Nebulizer 4 times a day albuterol and regular asthma medications with SINGULAIR. I have not recovered and I am still dealing with a hard time breathing. My doctor calls it Post COVID-19 Asthma.
This case was reported by a consumer via patient support programs and described the occurrence of suspected vaccination failure in a adult male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included abacavir sulphate, dolutegravir, lamivudine (Triumeq) tablet for hiv infection. Concomitant products included ascorbic acid (Vitamin C). On an unknown date, the patient received Flu vaccine at an unknown dose and Triumeq (oral) at an unknown dose and frequency. On an unknown date, less than a year after receiving Flu vaccine and unknown after starting Triumeq, the patient experienced vaccination failure (serious criteria GSK medically significant), flu symptoms and cold symptoms. On an unknown date, the outcome of the vaccination failure, flu symptoms and cold symptoms were unknown. It was unknown if the reporter considered the vaccination failure, flu symptoms and cold symptoms to be related to Flu vaccine. The reporter considered the vaccination failure, flu symptoms and cold symptoms to be unrelated to Triumeq. Additional details were provided as follows: The patient's concomitant medications included Dayquil and Nyquil. The age at vaccination was not reported. About 2 to 3 years ago, the patient started taking Triumeq at dose of 600/50/300 mg. The patient reported that he and his co-workers were having cold or flu symptoms. The patient was not feeling that bad. The patient was surprised to be experiencing this because he received a flu shot. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting. This case was linked with US2019AMR051611, reported for the same patient.
50% TEMPORARY LOSS OF HEARING IN LEFT EAR. REGAINED AFTER APPROX 45. MIN.  PAIN, SWELLING AND HOT TO THE TOUCH AT INJECTION SITE.
Patient awoke from a nap at 2:15, crying hysterically. She wailed with a high pitch without stopping until 6:45 p.m. The site of the injection was inflamed and bruised. She refused to nurse. After we gave her acetaminophen she calmed considerably. She had four episodes of diarrhea between 2:15 and 6:45. She developed a strange hiccop/cough that was intermittent throughout the evening.
Pain, redness, swelling. Ice pack, Benadryl tablets 25 mg every 8 hrs for 1 week.
Men of  2 was administered by medical assistant without diluent that vaccine comes with and just with sterile water. Pt is doing well, went to school today. Mother is aware most likely we will need to administer another dose since liquid vaccine component (the diluent) of Menveo contains the C, W-135, and Y serogroups, and the lyophilized vaccine component (the freeze-dried powder) contains serogroup A.
4 hours after shot -> eyes swelled and painful (in Rt eye). 1 AM Sun.
1st Gardasil vaccination on 2/19/08.  Second Gardasil vaccination April 2008.  3 weeks later, on May 9, she came home from school complaining of soreness in all her joints.  She had no fever or any other flu-like symptoms.  Medical tests have consistently been negative for arthritis, lupus or any other autoimmune disease the doctors could think of.  Neurological tests revealed no neurological source of the soreness and stiffness.  Nine months later, she is still experiencing joint pain.  2/20/09 MR received from PCP. In for 14 yr WCC on 2/19/08 with dx:  Well adolescent. Next OV 5/9/08 with c/o joint pain and swelling x 2 days.  PE (+) for swollen ankles. Dx: arthralgia. Returned 5/12/08 with increasing pain and swelling jaws, neck, knees, wrists and ankles. Tingling in feet. NSAIDS not helping.  Swollen joints on PE with decreased strength- 4/5 ankles, knees and wrists. Labs WNL. Medrol rx with some improvement, with return of pain/stiffness after. Walking stiff legged 5/16/08.  2/27/09 MR received from neurologist dated 6/25/08 with DX:  Pain, joint, musculotendonous, connective tissue.  Etiology unknown.   MR received from rheumatologist dated 12/9/08 and 2/3/09 with DX:  Enthesitis related JIA and Fibromyalgia temporally associated with Gardasil vaccine. Another consult noted discusses amplified musculoskeletal pain syndrome. ? idiopathic variant of stiffman syndrome. Pt reports continued stiffness, joint pain and decreased mobility. More fatigue. Restarted Methotrexate and Humira 2/3/09
Administration Error - bivalent booster dose administered 1 month after receiving bivalent booster
patient developed loss of appetite, hot and cold (for 2 weeks) and out of breath (2 weeks)
Discharge Date: Jan 11, 2023 Discharge Provider: MD Primary Care Provider : MD  COVID positive date 1/5/2023 PRESENTING PROBLEM: Acute on chronic respiratory failure with hypoxia   HOSPITAL COURSE: 92-year-old male with past medical history of chronic diastolic heart failure, chronic respiratory failure with hypoxia on 3 L of oxygen at daytime, 4-6 L with sleep, presented with cough, dyspnea, and increasing lower extremity swelling.  Patient tested positive for COVID-19 and influenza A and was also found to be on acute on chronic diastolic heart failure.  Patient was admitted and was started on Tamiflu for influenza a, dexamethasone for COVID -19, and IV Lasix for CHF exacerbation.  Patient initially had poor urine output on Lasix 40 mg IV 2 times a day so this was increased to 80 mg IV 2 times a day with the better urine output response.  Because patient was just recently admitted for another CHF exacerbation last month, Cardiology was consulted for assistance in management and outpatient follow-up.  With improvement of symptoms and decrease in weight, patient was eventually transitioned to torsemide 40 mg in the morning and 20 mg in the afternoon.  This was a change from his previous regimen of Lasix 40 mg orally twice a day.  Patient was discharged home on improved condition and will followed up with Cardiology as an outpatient.  Patient was also discharged on potassium 40 mEq daily. BMP check in 1 week
Two hours after the injection, my shoulder began to get sore. Eight hours after the injection, my shoulder was so sore that the pain was making me nauseous. Twelve hours after the injection, my temperature began to rise to 100.00. I had body aches, chills, and the overall feeling of being unwell.  24 hours after the injection, my arm was still sore but the pain was more manageable. 32 hours after the injection, the fever, chills, and body aches had resolved. 48 hours after the injection, the shoulder soreness was nearly resolved.
pt hospitalized within 6 weeks of COVID vaccine.  ED visit 3/25/21; Hospitalizations 3/25/21 and 3/30/21.
Though I had no adverse events after the first SHINGRIX dose, this second one was followed, surprisingly, by a number of symptoms after about three hours, lasting acutely during the night and calming somewhat after 18 hours or so. They include: Shakes, feverish feeling, accelerated heartbeat (to about 88 from normal 65), weakness, and acute muscular aches and aches in joints suffering from arthritis. I believe I also panicked somewhat before calming myself down and getting to sleep. I did not call 911 or other help, but I reported the events to the pharmacist the next day to ascertain that I could keep taking a course of LOTEMAX I've been on for two weeks.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
fever, arm swelling (pt reported it was swollen like a balloon), throwing up, fatigue, pain at injection site, difficulty raising arm up about; s/s began around 16-20 hours post vaccinations  Spoke to pt today (9/29/2022) and s/s are slowly improving
Received my 4th Moderna shot on Mon. May 2, 2022 at 5:20pm. The next day, Tuesday May 3, 2022 I woke up at 9:00am and was extremely dizzy. The room felt like it was spinning. I also felt very sick in my stomach. I wasn't able to get out of bed. Finally, at 3:00pm, I started feeling better and the dizziness went away.
Headache, dizziness, throat closing, roof of mouth swelling, hives, wheezing, coughing.
Dizziness, light headed within first 10 min. but continued Fast heartbeat - 5 hrs later while walking around house Itching all over body, face, head, light rash in thorax and inner tights- 8 hrs later Dizziness and weakness continues on 2-11-21
received booster dose instead of full first dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose). On 22-Jan-2022, ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Got very sick; Initial information was received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves patient (unknown demography) who was very sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Acute hypoxic respiratory failure due to COVID-19 pneumonia:  Completed course of Remdisivir. Symptoms also include nonproductive cough, wheezing, fatigue, vomiting. Received Actemra on 01/28/2022.  empiric antibiotics, IV steroids, nebs, oxygen.  On Lovenox for DVT prophylaxis, will switch to apixaban as outpt for 2 weeks.  Monitoring COVID-19 inflammatory markers. Completed steroids
NEUROPATHY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
This infant received vaccine in the left arm on 12/22/00. He has a 1/2 dollar sized round reddened area with red raised border to left shoulder with pinpoint area in the center. Received cold compresses, Motrin, and observed. Call back if not better, or becomes worse.
I had a headache and malaise starting 12 hours after my shot. This shot was shot 3, a booster shot. I received my 2nd dose on 6/12/21. The adverse events I am reporting started three days after my third shot, 12/26/21. I suddenly had red, itchy hives covering my ankles, and portions of both legs. The next night, in addition to the leg hives, I now had hives on both arms. My knees were also stiff starting that night, limiting the motion range.  Starting Friday 12/31, I had some hives on small portions of my torso.  I have not, as of yet, had trouble breathing, rapid heartbeat, or a swollen face. The joint stiffness has improved. I do not suffer from seasonal allergies, so I did not have any allergy medicine on hand.  I was snowed in for several days following 12/26-I could not get to a store until 12/31 due to the snow and my work schedules. I had some anti itch cream with menthol, which sometimes provided temporary relief for the itching.  I started taking diphenhydramine (25 mg each pill) on 12/31. It seems to have relieved the emergence of hives and most of the flaring up of them, but they have not gone away yet.
Information has been received from a Registered Nurse (R.N.) concerning a 25 month old female patient with allergies, rhinitis and R.A.D. who on 30-SEP-2005 was vaccinated with a first dose of Hib conj vaccine and on 07-JUL-2006 with a second dose of Hib conj vaccine. Concomitant suspected therapy included 2 doses of COMVAX the first dose was given on 27-JUL-2007 and the second dose was on 04-JAN-2006. Other concomitant therapy included OMNICEF, montelukast sodium, XOPENEX and PULMICORT. On 14-MAY-2007 the patient was hospitalized for haemophilus influenza type B infection. A throat culture identified HIB. On 21-MAY-2007 she was discharged form the hospital and was fully recovered. Additional ifnormation has been requested.
This spontaneous report as received from a pharmacist refers to an approximately 72 year old female patient (reported as in early 70s). Medical history and drug reactions/allergies were not reported. On an unknown date (when the patient was about 71 years old), the patient was vaccinated with PNEUMOVAX23 (lot, dose and route not reported). On an unknown date (when the patient was about 72 years old), the patient was vaccinated with PNEUMOVAX23 (lot, dose and route not reported). On an unknown date, the patient received 2 doses of PNEUMOVAX23 which were spaced only one year apart. No adverse effect reported. Additional information is not expected.
extremely runny nose; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing), notes: symptoms: runny nose. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "extremely runny nose".  Additional information: The patient was experiencing extremely runny nose which was the same symptoms that she experienced when she got COVID-19 in Jan2021. The patient couldn't tell if it's allergies or COVID infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported full body itching  and rashes all over his body hours after receiving the vaccine.  He said he took some Benadryl and after about 2 hours the rashes and itching reduced.
One of the vial was broken, the adapter was broken; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (12Oct2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5017, Expiration Date: Feb2025) for respiratory syncytial virus immunisation; for respiratory syncytial virus immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "One of the vial was broken, the adapter was broken". Additional information: Reporter stated, "We received a Shipment for the Abrysvo, the RSV(Respiratory syncytial virus) Vaccine and one of the vial was broken, the adapter was broken and so I do not know if you could help me replace one vial for us." When probed if vaccine was administered to any patient: Reporter stated, "No, I have to throw it away because it was broken."  Causality for "one of the vial was broken, the adapter was broken" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.