chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from literature on 10 May 2014. A 56-year-old female patient, whose concomitant medications were not reported, he received a dose of YELLOW FEVER VACCINE (batch number, dose number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The patient had no known allergies to medications, eggs, or vaccines, and denied a history of herpes or changes to her medication regimen. She reported no insect bites, trauma, or burns to the area. It was reported that on an unspecified date, after receiving Yellow Fever vaccine, the patient experienced an injection site reaction followed by a localized bullous fixed drug eruption. Hours after receiving the vaccine, a painful edematous plaque developed at the injection site. Four days later, she reported development of large, asymptomatic bullae localized to her nose. The lesions increased in size and eventually ruptured with minimal crust. She presented to clinic 10 days after receiving the vaccine. On exam, there was 1.2-cm erythematous, circular, superficial erosion with desquamative scale overlying the left nasal ala with scant hemorrhagic and serous crust. Superficial erosions were also appreciated on the columella. An erythematous patch surrounded the injection site on the upper right arm. Biopsy, culture, and direct immunofluorescence were deferred given the benign exam. Because the lesions were healing, no specific treatment was indicated. The eruption was cleared 2 days later without scarring or dyspigmentation. But at the time of this report, the outcome of other events was unknown. Documents held by sender: figure of Bullous fixed drug eruption.
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient has agreed to repeat this vaccine dose and has scheduled to return on 21 April 2021.
This spontaneous report as received from a registered nurse refers to a 67 years old female smoker patient, with rheumatoid arthritis, asthma, Gastrooesophageal reflux disease (GERD), diverticulosis, hypertension, osteopenia, obesity, panic attacks, allergy to PROCARDIA and allergy to citalopram hydrobromide. The patient was vaccinated with a first dose of PNEUMOVAX23 (Lot # not reported) in 2001, a second dose of PNEUMOVAX23 (Lot # not reported) in 2006, a third dose of PNEUMOVAX23 (Lot # not reported) on 29-FEB-2012 and a fourth dose of PNEUMOVAX23 (Lot # not reported) on 13-JUL-2012. No other co-suspects were reported. Concomitant medications included DIOVAN, ZANTAC, albuterol, methotrexate, folic acid, SIMPONI, lansoprazole, ADVAIR, MIRALAX, senna, LEUCOVORIN, ibuprofen, prednisone, CARAFATE, alprazolam, VICODIN, calcium supplement, calcium-magnesium-zinc supplement, nystatin and triamcinolone. The nurse reported that on 13-JUL-2012, the patient developed severe joint, shoulder and hip pain after she was vaccinated on 13-JUL-2012. The patient did not receive treatment for the adverse events. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing.  She was checked out by the attending nurse at the vaccine facility.  Her pulse was 120 and BP was 189/89.  Pt drank a bottle of water while her pulse came down.  About 5 minutes later her heart was racing again and BP back up.  She was monitored for additional 15 minutes.  During this time she had another episode with the same symptoms so she was rushed to the  ER.  Her heart rate was 110 and blood pressure still 189/?  She was monitored for about an hour and 20 minutes.  Pt was released from ER about and 1 1/2 ago and has not had another episode so far.  She was told to FU w/ PCP in 2-3 days.
about four hours after getting the flu shot. i started getting hives' my whole body itched. later that evening my ears were hot and swollen, next morning eyes were swollen, my throat was starting to feel itchy and tight thats when i went to hospital. they gave me two shots and a pill.
reports new onset of upper lip swelling two days following the COVID-19 vaccination. The swelling is mildly painful under her nose but is otherwise not red or painful. She is not experiencing fevers. She is experiencing mild malaise. She most recently received cosmetic fillers in the upper lip and cheek in October 2020.
Hospitalized (10.19.21 - current);  COVID-19 positive (10.17.21);  Fully vaccinated  Chief complaint Shortness of breath History of Present Illness:  Patient is a 61 y.o. male with a PMH including diabetes, COPD, T2DM, hypertension, obesity who presents for a 6 day history of worsening shortness of breath.  He reports that symptoms started approximately last Thursday and have consisted of shortness of breath, cough productive of clear sputum, decreased appetite. He reports he was unable to ambulate very short distances without getting winded. He is not on oxygen at baseline. Additionally, he notes that his eyes have been burning, with some yellow discharge which has improved.  He also endorses intermittent headaches since symptom onset.    He was previously seen in the emergency department yesterday as well as the day before and diagnosed with COVID-19 on 10/17/2021.  With these previous visits he was given Decadron 6 mg oral.  He also got a nebulizer and tried to use this for his breathing, but reports that his oxygen was still in the mid 80s.  He reports he is vaccinated against COVID-19, his wife was also recently diagnosed.  On presentation to the emergency department, patient arrived hypoxic at 84% on room air, tachycardic, afebrile.  He was placed on 6 L nasal cannula.  Patient given dose of Decadron and Remsevere.  He is admitted for further management of COVID-19 pneumonia. Progress Note from 10.26.21 (still admitted):  Subjective LOS: 7;  Patient seen lying on left side in bed.  States his breathing is about the same as yesterday but he does note that change from the high-flow nasal cannula to the intermediate flow nasal cannula.  He said this current setup is much more comfortable and easy to sleep.  He does not feel significantly short of breath with oxygen in place at rest but does continue to note dyspnea with ambulation.  Denies any additional symptoms such as chest pain, belly pain, nausea, vomiting. Assessment/Plan COVID 19 Pneumonia Acute Hypoxic Respiratory Failure  Oxygen requirement decreasing very slowly, still short of breath with minimal exertion Presenting symptoms: Shortness of breath, cough Vaccinated COVID 19 detected by PCR: 10/17/21. CXR with findings of streaky basilar airspace disease on 10/18/21. Current oxygen requirement 60% FiO2 HFNC Severe Respiratory isolation Dexamethasone 6 mg oral daily (day 10/10) Completed 5 day course of remdesivir  10/23 Daily labs CBC with differential, CMP, D-dimer  Tessalon pearls Monitor I/O Continuous pulse oximetry  Recommend proning VTE prophylaxis with Lovenox Renal function stable, continue IV Lasix 20mg daily COPD Acute exacerbation of COPD, now resolved Initially with acute exacerbation given increased SOB and sputum production.  - s/p azithromycin 500mg x 3d - Albuterol, dulera ordered
1st dose in August 2021, second dose in January 2023; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2021).   In JAN-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in August 2021, second dose in January 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 20-JUN-2023 The reporter enquired that what was the efficacy of a patient who had Shingrix August 2021 and then a second dose in January 2023. The reporter also enquired that should they receive another dose third dose. The vaccine administration facility is the same as primary reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
This case was reported by a healthcare professional and described the occurrence of hives in a 3-month-old female subject who was vaccinated with Pediarix for prophylaxis. Concurrent vaccination included Hib vaccine, RotaTeq and Prevnar all given on 25 June 2007. On 25 June 2007 the subject received 1st dose of Pediarix (unknown). On 25 June 2007, approximately 5 to 6 hours after vaccination with Pediarix, the subject developed hives. The infant was sent to an allergist for skin testing. At the time of reporting the event was resolved. The healthcare professional considered the event was possibly related to vaccination with Pediarix.
patient was in ICU (Intensive care unit) with pneumonia 3 times; Initial information was received on 18-Nov-2020 regarding an unsolicited valid serious case received from a non-healthcare Professional via social media.  This case involves a female patient of unknown age who experienced pneumonia 3 times and was in ICU (intensive care unit) (pneumonia), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch 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 a serious pneumonia 3 times (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and she was hospitalized for this event (was in ICU- intensive care unit).  It was also reported that she was in good health when she received the shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for event.  Information on the batch number was requested.; Sender's Comments: This case involves a female patient (unknown age) who experienced pneumonia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
a 74 y.o. female who has a pertinent medical history asthma, hypertension, hyperlipidemia, hypothyroid, anxiety, and diabetes mellitus that is diet controlled presented to the emergency department today for a week-long history fatigue, malaise, fever, and chill.  The patient noticed that her roughly 1 week ago she was feeling more fatigued and having chills.  It was not until this morning that her daughter decided to bring her to the ER to get checked out.  The patient is a somewhat poor historian and is unable to describe her exact symptoms that have progressed over the week.  While in the ER the patient was found to be febrile at 101.2 and hypoxic and was started on high-flow nasal cannula which improved her oxygen saturation to 92%.  She subsequently tested positive for COVID-19 while in the ER however her remaining blood work was relatively unremarkable.  Her chest x-ray demonstrated extensive multifocal bilateral airspace disease.  The patient was vaccinated with the Pfizer COVID vaccine on 09/17 and 10/8. The patient was given 1 dose of dexamethasone and was subsequently admitted to the hospital with the hospitalist team.   On exam the patient denies chest pain, fever, chills, nausea, vomiting, diarrhea, dizziness, lightheadedness.  She does endorse shortness of breath especially with activity.  She is a poor historian and cannot recall her specific symptoms and was progressed to lead her to the hospital.  There is no other family member at bedside to confirm her story.  I educated the patient on the plan of care to start steroids, remdesivir, and monitor her oxygen.  She agrees with this plan of care and all questions and concerns were addressed with the patient.
Patient states that in the evening after Shingrix vaccine he had chills to the point of putting on lots of layers in order to get comfortable.  He also says he had about 10-15 minutes where breathing was difficult.
Influenza mfr: Glaxo Smith Kline. Severe body aches, nausea, low grade fever 100.5, headache, back pain, lightheaded, dizziness, no appetite. Had to give TYLENOL 500mg every 4 hours and ibuprofen 600mg every 6 hours regularly x 3 days. She had arm soreness, but no swelling, edema, hematoma/bruising at either site. She had side effects from her #2 HPV, but not as severe. She has regular flu shots every year with no side effects or problems. I feel it is related to the HPV due to her last injection of HPV.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-DEC-2015 at 10:26, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I woke up the next morning and I had an extremely painful throat. I had chills, and most likely had a fever as well. I had pain and swelling around my throat. These symptoms lasted for about 4-5 days. My primary care tested me for strep throat and it came back negative. After the 5 day period I started to feel much better. As of now I am not experiencing any of these symptoms.
Case number PHEH2013US024163, is an initial spontaneous report received from a pharmacist on 18 Nov 2013. This case refers to a 09-years old male child patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX, (batch number: 010021A) intramuscularly on 16 Nov 2013. No adverse event was reported following this administration error.
She developed a headache, chills, body aches. She states that all she has done today is sleep. She feels similar to if she had the flu. She has now developed an axillary lymphadenitis.
N/A at the moment. The event happened 6/21/22 at 10:25 AM
I had burning in my nose and felt like I had a cold. I did not have a fever but was very tired. It lasted 3-4 days for the cold symptoms but I am still experiencing fatigue. I used a home test to diagnose the COVID-19.
Patient self reported localized clusters of pruritic vesicular at injection site left deltoid, back, right shoulder area. Developed on 6/13/07; resolved over next 7-8 days.
Feeling of congestion & ringing in ears, progressively got worse, thought it would go away, it didn't.  Worse in left ear.
Pt recvd 3 doses of Recombivax in ? 1988 & reporter indicated that titer taken 4 wks ago (?NOV 91) indicated pt to be a non-responder; booster dose of Engerix-B given 3 wks ago (?NOV91);
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. RA Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Diarrhea, vomiting, fever, chills, worse flu in a long time. sniffles, dehydration, IV fluids needed, nausea meds, etc, ER several visits.
Feeling light headed, shaky, cold sweats, blurred vision, itchy below her knees.
Non stop crying, red very swollen blue feet, red toes, blue strip on right leg.
Father and son came in for first COVID vaccination, I had a dose that was going to expire in 10 minutes so I wanted to help the father out and give him the dose I had and not waste it.  I asked the father his age and he said 12 so I administered the vaccine.  He came back and filled out the paperwork and the child was only 11 years and 8 months.  I called the physician and after a week or so got a call back and they instructed me to call the health department as to my next steps.  I spoke with the health department today 10/21/21 and they advised not to give second dose until recommended by CDC
Erythema, skin warm and tender to touch itchiness on site left arm. Site measures 10x17cm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; ESTRADIOL; MELOXICAN; MONTELUKAST; ACYCLOVIR [ACICLOVIR]; DEXAMETHASON [DEXAMETHASONE], start date: 08Sep2022, stop date: 17Sep2022; WELLBUTRIN; OMEPRAZOLE; XANAX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12Sep2022) Negative, notes: 1st covid tested negative on day 5; (25Sep2022) Positive, notes: tested positive 13 days after testing negative from 1st covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient was given Paxlovid as treatment.
No adverse effects reported.; one patient received MMR II and VARIVAX via intramuscular route; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Concomitant therapies included sterile diluent. Information about pertinent medical history, drug reactions or allergies was not provided.          On 11-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S021926, expiration date 15-JUL-2021; dosage detail and strength were ot provided) intramuscularly in the left thigh and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin (rHA)) (lot # S013539, expiration date 02-MAY-2021; dosage detail and strength were not provided) intramuscularly in the right thigh for prophylaxis (Inappropriate route of vaccination). No adverse effects were reported.
has not received his second dose as of today, it's been more than 42 days since he had received his first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received his second dose as of today, it's been more than 42 days since he had received his first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received his second dose as of today, it's been more than 42 days since he had received his first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received his second dose as of today, it's been more than 42 days since he had received his first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.
Child comes in for follow up of a febrile seizure, was seen in the ER last night. She apparently had decreased appetite throughout the day yesterday, but mom did not note her feeling warm until the evening hours. She went to get some ibuprofen for presumed fever and came back and found the patient seizing in a generalized fashion after falling down. She picked the baby up to mover her to a different location and noted that she was drooling; but after only approximately a minute, the seizure activity stopped. She subsequently was lethargic for the next minutes. Mom called 911, and the patient was brought to the ER.  In the ER, the patient was lethargic but shortly awoke. No further seizure activity was witnessed. She had a temperature of 103. CBC showed a white count of 16 000 with a nonspecific differential. blood culture was sent. She was thought to have an infected ear and given orally high dose amoxicillin after the blood culture was obtained. Ibuprofen was also given. There is no family history of febrile seizures or seizures. Mom has no developmental concerns, and the baby is currently on FAR with her sibling at the same age. There was no obvious cold symptoms prior to the onset of fever. She did have her one year shots on November 15, which included an MMR.
2 hours after vaccine adm. had fever of 103.8, pale, lethargic, no appetite - "almost passed out".  Mother gave antipyretics, child sleep 3 hours (some difficulty arousing for temp check).  Fever continued for 48 hours, but activity improved.  Appeared fine after 48 hours.
Erythematous itchy area upper arm L, seen by me 2/5/07. Pt already seen by Peds first urgent care and put on Keflex. Recommended Benadryl PO, Topical Cortisone.
Shrill screams of pain, drawing legs up from great abdominal pain, vomiting. Later in the day bloody stool. No treatment at home. Brought baby to her pediatrician and upon description of symptoms and examination the pediatrician sent us to hospital emergency room. Ultrasound and x-ray uncovered intussusception. Treated with "air enema".
Inc numbness of rt leg began w/in hrs of inject & condition progressed by JUN90 to bilat myelopathy. numbness in rt leg progressed to involve hip, proceeded all the way to foot, assoc w/weakness of leg, irreg bowel & difficult urinating.
high fever 103-2 1/2 days Sunday-Wednesday; rash started on face Monday 2APR, 3APR & by 5APR all over body, nose, mouth, ears; Wednesday MD saw pt had ear infect bilat, atypical measles
I started 2/11/21 at 11:45 am to have stomach cramps. The stomach cramps started mildly. Around 1:30 pm, the stomach cramps became very intense followed by hot flashes and nausea. I vomited twice and caused my head to ache. I decided to be observed. Once I arrived at clinic, I started to have chills and muscle pain.