chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. There were not concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with unspecified and improperly stored doses of ZOSTAVAX lot number L032403 expiration date 26-NOV-2016 and L023118 expiration date 24-SEP-2016 (route, dose, dose number and anatomical place of vaccination were not provided). No adverse effects were reported. Temperature/time frame: 30-JAN-2016 - 14 degrees C for 4 hours; 01-FEB-2016 -14 degrees C for 44 hours and -12 degrees C for 9 hours; 02-FEB-2016 -11 degrees C for 15 hours; -10 degrees C for 9 hours; 03-FEB-2016 -9 degrees C for 15 hours and -8 degrees C for 9 hours; 04-FEB-2016 -7 degrees C for 15 hours and -6 degrees C for 9 hours; 05-FEB-2016 -5 degrees C for 15 hours and -4 degrees C for 9 hours; 08-FEB-2016 -3 degrees C for 63 hours. Cumulative -10 degrees C to -14 degrees C for 81 hours (unlimited ranged) and cumulative -9 degrees C to -3 degrees C for 135 hours. No previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Received COVID vaccine on Saturday 1/2/2021. Originally was about the size of a quarter (was also hot and red) but by evening had increased to size of a half dollar. on Monday, Tuesday, and Wednesday the spot was the size of a palm and was bright red and hot. Patient appplied ice and took diphenhyramine thorughout. Her last dose of diphenhydramine was 1/5/2021 evening. She reported on 1/6/2021 since reaction had not resolved. At integumentary exam: Right, Arm, TTP at the inferior aspect of the R deltoid muscle. Unremarkable temperature change of area of concern compared to the other areas of her R arm or to her L arm. Pt had a photo on her phone that showed redness at the deltoid area, where she demarcated it, and compared to today it has significantly improved, and close to her flesh tone. No drainage present or lumps felt. Not erythematous. Pt advised to monitor changes of R deltoid area and note if redness returns, notified that cellulitis was not present at time of exam. Instructed pt to use APAP, ice, and diphenhyramine PRN.  1/29/2021: Pt received 2nd dose of vaccine with no issue.
PATIENTS  REPORTS SLOW SPEECH, DISTURBED PERCEPOTIOPN AND SLOW REACTION TIME. PATIENT WAS REFERRED TO PRIMARY CARE PROVIDER FOR FURHTER EVALUATION
Fluzone Quad instead of Fluzone HD with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 73 years old female patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Oct-2023, the patient received suspect Influenza Quadrival A-B Vaccine, suspension for injection (strength: unknown) [Fluzone Qiv] (lot U8096BA, expiry date: 03-Jun-2024, via intramuscular in left deltoid for prophylactic vaccination (immunization), instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], Suspension for injection in pre-filled syringe (strength: unknown) (lot number, expiry date: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization), with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested for fluzone high dose.  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
after 1st immunization mild injection site pain; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EJ1686, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 30Dec2020 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included hypothyroidism, arthritis, chronic neck R shoulder pain, migraines, submaxillary gland removal, and tubal ligation. The patient had COVID prior vaccination. The patient was not pregnant at the time of reporting. Concomitant medications/other medications within two weeks included levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN), ibuprofen, amitriptyline hydrochloride (AMITRIP) and vitamin D3. There was no other vaccine within four weeks of vaccination. The patient previously took amoxicillin, cefadroxil (DURICEF), meloxicam (MOBIC), and esomeprazole magnesium (NEXIUM) and experienced allergies to all. On an unspecified date, after 1st immunization, the patient experienced mild injection site pain. Reported labs performed included chest xray, CT head neck, and EKG with unknown results on an unspecified date. The patient was not Covid tested post vaccination. The outcome of event was recovering.
Symptoms: Welts, Blisters, and Rash. Slight fever. Time Course: Months to reverse skin issues.  Unsure of any other symptoms that could still have happened.
Myalgia Weakness Narrative: Starting the evening of injection, she couldn't lift her arm, pain persisted for 2 weeks. Reports her doctor said she got shot  in the bone.
Nausea; Very tired; Swollen lymph nodes under left armpit; Fever; Right armpit pain; Really cold; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's wife) reported for a 45-years-old male (Reporter's husband) received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 15Apr2021, at 15:45 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced swollen lymph nodes under left armpit, fever, right armpit pain, really cold. On 28Apr2021, the patient experienced nausea, very tired. Clarified swollen lymph nodes are in the left armpit. Left arm was injection arm. Swollen lymph nodes in are not as bad. Right armpit pain: Hurts, but not as bad. Currently is no swelling under the right armpit. Pain is gone as of now. Nausea: Started this morning, but is not as bad. Fever: Complained of being really cold last night. Had a slight temperature of 99.8. It broke sometime during the night because caller just took patient's temperature and he does not have a fever. Very tired: Is very tired this morning. Patient is laying in bed, which he doesn't normally do. The outcome of the events swollen lymph nodes under left armpit, nausea was recovering. The outcome of the events fever, right armpit pain, really cold was recovered on 28Apr2021. The outcome of the event very tired was not recovered.   No follow-up attempts are needed. No further information is expected.
I received the first Covid-19 Moderna dose at roughly 8:47 a.m. After waiting 15 minutes I continued with my normal routine. I took (2) Tylenol anticipating symptoms from the vaccine. I finished my workday and got off around 4:00 p.m. Got home and ate dinner around 5:00 p.m. I did a light workout with the Nintendo Switch Adventure Fit game for 30 minutes. At 8:00 p.m. I began to feel adverse effects. I was reading to the boys when I felt a general all-around weird feeling that almost made want to stop reading. As I kept reading, I found it at times difficult to figure out words. Which slowed down my usual reading speed. I read for 30-45 minutes and this would happen intermittently. After done reading I proceeded to tell my husband about my day and dreams. So sure, of what I was about to say but would suddenly forget. Regaining my thoughts, I would finish my story but would then suddenly forget again. I would also start tasks, like putting my dirty clothes in the hamper, but then lose focus on that task. Thinking maybe I just needed a good night?s sleep, I went to bed. Through out the night I just felt waves uneasiness. I would fall asleep but then wake back up again feeling weird. My hands were shaking, possible response to fear of the effects. I seemed to focus on my heart beat every now then making me think I might have experienced a slight rapid heart rate. I would also feel a weird intermittent fuzzy feeling that would rush from the back of my head to the front of my head. It was almost like a warning that I was going to feel bad again. Eventually, not knowing the time, I fell asleep. The next morning, I woke up at approximately 6:00 a.m. I felt fatigued mentally and physically, had a mild headache, slight fuzzy headed, slight dizziness, slight nausea and had a sore arm. I took (2) Tylenol around 9:00 a.m and decided to report my symptoms to my PCPs office and made an appointment with an available ARNP. I took (2) Tylenol again at 6:00 p.m. I felt almost back to my normal self the third day after my vaccination.
4Y/O patient presents with 3rd of covid vaccine. The LPN administered Pfizer pediatric (6m-4y) monovalent instead of pfizer pediatric (6m-4y) bivalent. Patients has no side effect for the vaccine. LPN has been educated about the Pfizer schedule and verbally understand.
This spontaneous report as received from a nurse and refers to multiple unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M041768 expiration date 25-JUN-2018, lot# N005078 expiration date 22-NOV-2018, lot# N004812 expiration date 04-OCT-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007044.
pt could not walk-has lump the size of fist on rt thigh & t104; pt limping; 27APR94 t104.6; pt taken to ER t105.9 to 106.9; pt shaking & lethargic; dx acute bronchitis; exp runny nose & sore throat, cough; r/o pneumonia, r/o sepsis;
3/20/2021 Emergency Medicine Exposure to COVID-19 virus Dx Covid-19 Screening  Reason for Visit Progress Notes (Physician Assistant) ? ? Emergency Medicine ? ? Encounter Date: 3/20/2021 ? ? Signed Cosigned byMD at 3/22/2021  1:59 PM Expand AllCollapse All      MDM Number of Diagnoses or Management Options Exposure to COVID-19 virus:  Diagnosis management comments: Here due to a Covid positive exposure from his daughter who he lives with who tested positive for COVID-19 on March 16, 2021.  Patient has no symptoms at this time.  Vital signs are within normal limits except for an elevated blood pressure 164/97 mmHg.  Patient states that his blood pressure is elevated when he goes to the doctor's office.  Patient instructed to monitor his blood pressure and if remains elevated he is to follow-up with his PCP for further evaluation.  Physical examination as documented.  Orders placed for COVID-19 PCR.  Obtained and results pending at this time.  Quarantine instructions discussed.  Diagnosis exposure to COVID-19.  Patient struck to follow-up with his PCP as needed.
Patient is 12 years old and received dose of 0.2mL. Patient's mother informed. CDC administration errors guidance reviewed and states "Do NOT repeat dose." Patient observed for 15min with no adverse reactions noted & discharged home with parent.
fainted & fell to the floor while waiting in the pharmacy "waiting area" post vaccine - within minutes of getting the dose.  had to be taken by Ambulance to the ER where they did EKG testing, etc before releasing us to go home - we got home about 3 hours after the incident 1st took place
Pain, redness, swelling and later a red swollen line to my elbow.  I still have a red swollen area around my elbow that is painful to touch.  I have a brown area where the vaccine was injected.
COVID + 10/25/22 - Vaccination status - moderna x3 Discharge Summary  HOSPITALIST                                              Discharge Information: Discharge Provider:  MD  Primary Care Provider :     Procedures to be scheduled by PCP: None   Results/Procedures requiring PCP followup: None   Admission Date: 10/25/2022 Discharge Date: 10/30/2022   Admitting Diagnoses: Acute hypoxemic respiratory failure due to COVID-19    Details of Hospital Stay PRESENTING PROBLEM:  Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 85 y.o. male  who presents to hospital with shortness of breath.  Patient attended a wedding 10 days ago where multiple people became sick, including his wife.  He began to feel ill 3 days ago, with fatigue and cough.  Symptoms gradually worsened and this morning he had a pulse ox of "50%" at home according to his wife.  EMS was called and the patient brought to the ED.  He required a NRB mask to maintain adequate sats in the ED.  CT showed no signs of PE but bilateral ground glass and tree in bud opacities.  COVID testing was positive.  Because of his severe hypoxemia he was referred to the hospital and transferred to hospital for further evaluation and care.   Patient was admitted to the critical care unit and treated with steroids remdesivir and empiric antibiotics to cover community-acquired pneumonia.  He was managed with high-flow nasal cannula oxygen which was gradually weaned.  He continued to have significant weakness hypoxia and shortness of breath.  He underwent aggressive respiratory hygiene, physical occupational therapy.  Gradually his symptoms did improve.  He was weaned back down to his normal 2 L nasal cannula.  He improved with physical therapy and was felt that he did not need subacute rehab.  He completed a 5 day course of remdesivir and antibiotics.  He is discharged in stable condition on dexamethasone for 3 more days.  Home care will be arranged for him and he will follow up with primary care provider within the next week.  He is instructed to continue to self isolate for 2 more days which will be 10 days from symptom onset.
This 81-year-old female with a history of coronary artery disease, CABG, diabetes mellitus, hypertension, stroke, hyperlipidemia, anxiety and depression was brought to the ED by an ambulance for the complaint of multiple concerns.  The patient is a poor historian.  The son states that she has been confused off and on for the last 1 year.  However, he did not observe any major change in her mental status.  The son states that her blood sugar was low at 50 in the morning.  He also states that he managed to bring up the blood sugar to 357 by the evening.  It appears that the patient fell 2 days ago and sustained a bruise on her right side.  The paramedics stated that her oxygen saturation was in the high 80s when they arrived at her residence.  The patient apparently told the paramedics that she has been having loose bowel movements.  She also complained of a shortness of breath.  The paramedics stated that she needed supplemental oxygen to keep the saturation consistently above 90%.   The son stated that she had 3 loose bowel movements today.  There was no blood in the stool or black stool.  She had an occasional cough.
Started to feel sweaty and then felt faint and tingly. This started less than 10 min after injection. I have had this happen before with a previous injection a few years ago, except that time I actually passed out. This time I felt very faint and the nurses said I looked "grey and pale" but did not lose consciousness
Ipsilateral (right) axillary pain w/o palpable lymphadenopathy. Fatigue, flushed & Hot Pretty sore after the vaccine worst local soreness of any vaccine. Next morning (Jan 7) at 0900: HA, Fatigue, flushed & warm. Brain fog- couldn't think. Made it through the day. Joints worst body ache. Tylenol some help. Combined with ibu. Feverish sleep-sweaty & hot. Jan 8th waves of symptoms. Friend suggested Vit D. It helped her feel much better after an hour. OK for an hour, then symptoms returned for two hours. Axillary pain. Couldn't sleep on that side.
Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Chills and soreness at injection site Narrative:  Missed one day of work.
urinary tract infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.
Emesis, trouble breathing, rash, itching, nasal congestion within 20 minutes from influenza vaccine.
Headache, Myalgia, CHILLS, FLU LIKE SYMPTOMS Narrative:
Right upper arm anterior aspect - edema, firm erythema 3-4" length. Discomfort with palpitation, no streaking, afebrile. ? early cellulitis dx. Treated with Keflex 250/5 - 6ml's TID for 10 days; warm compresses. 1 week follow up.
Patient fainted briefly after getting the vaccine. The pharmacy called the paramedics. She became conscious a few minutes after and was fine. She did not go with the paramedics. I called her later in the day to check on her. She was fine.
Fever 100-101, body aches, shaking, and  migraine headache until Sunday 2/28/21.  Continued with body aches and headache until 2/29/2021.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 29-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported pain in site of application. Per patient, pain gets worse by the end of the day.
she have never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 22nd September 2022). Additional patient notes included the patient was immunocompetent.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she have never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-May-2023 No lot number information available at the moment of the call. The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Received 2 live vaccines (YF-VAX and MMR) in 2 days with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Medical Information (Reference number- 00839281) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 30 year old male patient who was received two live vaccines in two days apart YELLOW FEVER VACCINE [YF-VAX] and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (Inappropriate schedule of product administration).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Oct-2021, the patient received a 0.5 mL dose of suspect YELLOW FEVER VACCINE (batch number and expiry not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  On 14-Oct-2021, the patient received a dose Booster dose of suspect MMR not produced by Sanofi Pasteur (batch number and expiry not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate schedule of vaccine administered (latency same day).  It was reported "Physician assistant at a travel clinic reports that she has a patient who received YF-VAX and MMR vaccines 2 days apart. Physician assistant states that the patient received YF-VAX at a different clinic on 12OCT2021. 2 days later, on 14OCT2021, the patient saw his primary care physician and was tested for MMR immunity; it was found that the patient was not immune to MMR. The patient's primary care physician administered MMR booster to the patient on 14OCT2021. On 01NOV2021, the patient went to the travel clinic and it was found that the patient received 2 live vaccines (YF-VAX and MMR); they were not administered simultaneously and they were not administered 30 days apart. Physician assistant asks if YF-VAX or MMR vaccine need to be repeated since they were administered 2 days apart? Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 4 weeks to minimize the potential risk for interference. If 2 such vaccines are separated by less than 4 weeks, the second vaccine administered should not be counted and the dose should be repeated at least 4 weeks later. Physician assistant states he received these vaccines because he will be traveling."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure, elevated pulse.  Most symptoms lasted for 6-9 weeks.  Dizziness, on-a-boat feeling, occasional headaches continue still (3 month after)
Flu like symptoms: headache , body aches, fever,  chills, night sweats