chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. The patients drug allergies and pertinent medical history was not reported. On 26-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA10956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012908. 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946. 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954. 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959. 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, 1407USA013014 (same reporter link). Additional information has been requested.
BRIEF OVERVIEW: Admission Date: 8/29/2023 Discharge Date: Sep 2, 2023 Discharge Disposition:  home health care svc  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: History of bacteremia [Z87.898] Community acquired pneumonia of left lower lobe of lung [J18.9] Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) [A41.9] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 75 y.o. male with chronic combined CHF (LVEF 23%), NICM, hx endocarditis in setting of MRSA bacteremia treated in March 2023 on suppressive doxycycline, and chronic back pain.    Patient presented after 7 days weakness, fatigue, fever. He was septic, COVID-19 positive, and CXR with questionable subtle pneumonia in LLL.   Patient remained on room air during his hospitalization. He was treated with Remdesivir (ends on 9/3/23) and supportive care. With concern for possible pneumonia the patient received Ceftriaxone IV and was continued on his home suppressive doxycycline. The patient was febrile overnight on 8/30. Infectious work up included negative legionella antigen, negative strep pneumoniae antigen, blood cultures remained negative and sputum cultures remained negative.   PT/OT assessed the patient and recommended home with home health/PT/OT. Patient was discharged in stable condition on 9/2/23
Itching began 20 min after injection itching in arm, back, neck, hair and face red. Inj site warm/red. Took 25 mg BENADRYL. Symp resolved.
No additional AE; a TE with PROQUAD; was administered outside of the indicated age range in the PI.; This spontaneous report was received from an office manager referring to a 18-year-old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       From 19-AUG-2022, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status recombinant Human albumin (rHA) lot # U039261 with expiration date 09-JUN-2023 underwent temperature excursion and was administered to the patient on 05-JAN-20213 at a dose of 0.5 mL for prophylaxis (strength, dose , route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. The temperature of exposure and the duration time of the temperature excursion were not reported.
NIGHT OF IMMUNIZATION ARM SWOLLEN, RED, PAINFUL, DEVELOPED FEVER, MUSCLE ACHES ALL OVER, HEADACHE.  3 DAYS LATER ARM STILL SWOLLEN, HAS 2 X 2 CM INDURATED WITH SURROUNDING ERYTHEMA OF VACCINE.
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported).  After approximately 6 days from vaccination, the patient developed a rash.  The patient sought medical attention by a phone call and the outcome was not provided.  The nurse stated that she was filling out a VAERS form related to this situation.  Additional information has been requested.
local rxn on lt arm, red, warm & swelling area bout 7x7cm around inj site;
This spontaneous report was received from a pharmacist and refers to an adult patient around the age of 41 years old. The patient's medical history included pneumonia. The patient's concurrent conditions included unspecified pulmonary problems. No information regarding concomitant medications was provided. On an unknown dates, reported as during unspecified flu seasons, the patient was vaccinated with two doses of PNEUMOVAX 23 (doses, routes of administration, lot # and expiration dates were unknown) and a dose of PREVENAR (dose, route of administration, lot # and expiration date were unknown), all for prophylaxis. No adverse effects were reported.
Patient was suffering from synocope, lightheadedness, and nausea/vomiting.
Received shot 12/23/2020 with only mild headache and tiredness the day following the shot. On 1/3/2021 to present I had swelling, redness and itching around injection site. On 1/6/2021 I had seemed medical assistance and was prescribed hydrocortisone 2.5%, Claritin, Pepcid and Benadryl.
Flu like symptoms. Hugh fever 102. Headache, body aches, chills, extreme dizziness, lightheadedness
This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. The patients medical history and current conditions were not reported. On 05-JUN-2014 the patient was vaccinated with improperly stored M-M-R II (albumin status/therapy type: unknown) (dose/frequency, route of administration were not reported) (lot # J000202, expiry date: 19-JAN-2015). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. This case is linked to 1407USA012205, 1407USA012206, 1407USA012207 and 1407USA012208 (same reporter link). Additional information has been requested.
received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days). On 10-Sep-2021, PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Significant follow up received: Patient initials and DOB updated.
Initial unsolicited report received from a consumer on 08 June 2016. This case involves a 20-year-old female patient who was vaccinated with a dose of Adacel (batch number, route and site of administration not reported) on 07 June 2016. The patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to mortin. Illness at time of vaccination and concomitant medications were not reported. On 07 June 2016, same day following the vaccination, the patient had very sore arm, difficult to move arm, red streaks running down arm, severe headache, no appetite, and feeling of throat closing. The symptoms were continuing as of 08 June 2016. Laboratory data and corrective treatment were not reported. The patient had not recovered from events. List of documents held by sender: none.
Public Health Nurse provided me a written report from a patient that had an adverse reaction after receiving the Influenza vaccine. The PHN's written pt. complaint described the symptoms as (L) upper arm pain with redness and warmth to touch which current extends to (L) breast. Pt. also noticed rash from (L) deltoid area to above the elbow. Denies rash in breast. Pain got progressively worse since 2/19/08 but localized to (L) arm and (L) breast. Pt denies any flu like symptoms. Pt advised to see PMD /emergency room as soon as possible. Pt education given in common side effects lasting 1-2 days. Concern regarding rash; body aches. Pt verbalized understanding
This spontaneous report was received from a doctor of pharmacy refers to two patients of unknown age (gender unspecified0. On 11-DEC-2012, the patient was vaccinated with an expired dose of ZOSTAVAX, lot number reported as (671452/1124AA, expiry date; 12-OCT-2012, dose and route not reported). No concomitant medications were reported. No symptoms were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
finger nails and tips turn blue; Raynaud's disease; This is a spontaneous report from a contactable consumer (patient).    A 37-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jan2021 12:00 PM (Lot Number: EL8982) as single dose for COVID-19 immunisation. Medical history included anxiety and penicillin allergy. The patient was not pregnant. The patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. The patient did not receive other vaccine in four weeks. The patient received the first dose on 28Jan2021. On 09Feb2021 10:00 AM, both of her fingers near her finger nails and tips turned blue. (This had never happened to be before). Today, she was diagnosed with Raynaud's disease. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included Amlodipine. The patient had Covid test post vaccination (type: Nasal Swab, name: COVID-19 Ag CARD) on 11Feb2021 with the result: negative. The patient received second dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EM9809) in left arm on 17Feb2021. The outcome of the events was recovered with lasting effects (sequelae).
This solicited report was received from a 55 year old female patient as part of a marketing research, referring to herself. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date in 2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. The needle hit the bone and it was very painful. The outcome of the event was unknown. The causality between PNEUMOVAX 23 and the event was unknown. Additional information is not expected as there was no consent for follow up.
R ear tinnitus : 10/18 x 4 hours  R hand ( pins and needles) that lead to inner area of full Right arm and hand  numbness: 10/19 -10/23 Occipital headache ( different than my migraines) 10/24 to ongoing ( today 10/25)
Upon administering vaccine at 9:50am, needle came detached from syringe. Was able to administer some of dose before syringe became completely detached, but at least half of dose (0.25ml) spilled out and was not injected.    Consulted with MD, in-clinic. Per MD, administered 0.25ml (half dose) of Moderna Covid-19 vaccine 4 hours after 1st dose attempt (at 1:50pm).
patient received a dose of Menactra on 14th of November 2020 that had expired on the 30th of August 2020, No AE; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 12 years old female patient who was administered with 0.5 ml expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] ( lot number: U6346AA and expiry date:30-Aug-2020) via unknown route in left arm for prophylactic vaccination on 14-Nov-2020 (Expired product administered).  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included ADACEL and HPV VACCINE for prophylactic vaccination.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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 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.
18SEP98 1 day p/vax pt devel red raised papular rash;rash cont;
pt recvd vax & became pale around mouth & tip of nose; sleepy; BP 60/30; O2, elevated legs, BP inc to 90/60, color improved, monitored approx 1 hr;bp stable, at 70's/50; f/u call in eve, pt doing fine;
Extreme dizziness, nausea, headache / migraine , body weakness, diarrhea, total body weakness, dehydration, feeling of unwell lasting 7 days. Migraine lasting 5 days straight and now suffering from them daily ever since. Extreme fatigue lasting 7 days.
First few days (12/23-12/26) she described feeling very sick, stayed in bed, mild pain and swelling at injection site. Unsure if afebrile or not. Noticed upon waking on 12/27/19, large red, swollen, painful area on left upper arm. Came into clinic for eval. Affected area red, swollen, warm to touch and measures 20cm long X 10cm wide.  Possibly cellulitis, provider prescribed abx.
Group B strep positive; Depressive disorder; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 11-Feb-2020, concerning a 30-year-old female pregnant subject of body weight 164 lbs, height 62 inches and body mass index (BMI) 30, enrolled in, a prospective observational safety study.  The subject's medical history included BMI increased.  The subject's concomitant medications included Citranatal B-calm (ascorbic acid, calcium citrate, colecalciferol, folic acid, iron pentacarbonyl, pyridoxine hydrochloride) as vitamin. It was reported that the subject had late entry prenatal care.  The subject's obstetrical history included three previous pregnancies with three previous full term live births. The subject had no maternal or paternal history with major congenital malformations (MCMs). The subject had no history of offspring with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period date (LMP) was 28-Jun-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) was 03-Apr-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On 22-Oct-2019, at approximately 16 weeks of gestation, the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunization.   On an unspecified date, after vaccination, the subject developed depressive disorder and group B streptococcus positive.   At the time of this report, the outcome of the events depressive disorder and bacterial infection due to streptococcus group B was not resolved.  The event of bacterial infection due to streptococcus, group B was assessed as serious due to the criterion of medical significance.   The reporter did not provide causality assessment to Flucelvax QIV.  Company Comment: Flucelvax QIVc was administered at approximately 16 weeks of gestation. A subject experienced Beta haemolytic streptococcal infection and depression an unknown amount of time after vaccination. Chronology needs more clarification. Causal role of the suspect product cannot be totally excluded and is assessed as unlikely related for both events (defaults to "related" in the safety database for reporting purposes). Exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: Flucelvax QIVc was administered at approximately 16 weeks of gestation. A subject experienced Beta haemolytic streptococcal infection and depression an unknown amount of time after vaccination. Chronology needs more clarification. Causal role of the suspect product cannot be totally excluded and is assessed as unlikely related for both events (defaults to "related" in the safety database for reporting purposes). Exposure during pregnancy is assessed as not related per company's conventions.
First dose in left arm with significant pain and swelling in left axillary lymph node 6 days after vaccine. This still hurts 6 weeks later.  Second dose I chose to have it in my other arm since first arm still hurt.  Same problem. Lymph node swelling in right axillary lymph node the next day.  Problem: This side effect has not been widely communicated. I did not know that this was a side effect and did not connect it to the vaccine the first time because it happened 6 days after my vaccination date. So, this caused me to go to two doctors. The first doctor was online and did not know the problem but suspected that I could have a DVT. She did not know that this was a side effect. So, she sent me to an in person doctor who recognized that it was a vaccine side effect. Please add this side effect to your publicity to save others from having an unnecessary doctor's visit.
This spontaneous report as received from a Nurse Practitioner refers to a female physician of unknown age. On an unknown date in 2013, a few days ago, the patient was vaccinated with ZOSTAVAX (route, dose, and lot # were unknown). The morning after Vaccination, the patient experienced pain across her body, down to her legs and in her joints. There was not treatment given for the event. The outcome of event was reported as recovered/resolved. The patient did not sought medical attention. The relatedness for pain across her body, down to her legs in her joints was not reported for ZOSTAVAX. Additional information is not expected.
fever up to 103 on the day of vax;also had high pitched crying for 2-3hrs;episode of limpness & paleness,lasting for about 2hrs;no treatment needed;
pt reports shortly p/vax devel pain & redness in lt upper arm;this slowly progressed involving the entire lt arm w/significant swelling, pain, & erythema;low grade fever of 100.5 & shaking & chills;
swelling in the arm; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An adult patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in the arm". It was unknown if therapeutic measures were taken as a result of peripheral swelling.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Pt stated being in first trimester of pregnancy, she was recommended to speak to her primary care provider or OB, Pt stated that she had spoken to a few providers, was asked if she was consenting and sure to receive it 9/10/2021 she stated she wanted to proceed with receiving the vaccine. Pt. c/o tightness in the throat and tingling present throughout her body.  Pt assessed, vitals read BP-122/74, HR- 80, RR-18, O2 sat-99%. Pt laid down and provided ice pack to throat as pt. stated feeling tightness as if throat was swelling. Pt A/O to place and time and able to speak without problems. Was provided a cup of water and able to swallow without difficulty. No audible wheezing present. Vitals assessed at 5:03pm BP-122/72, HR-76, RR-20, O2 sat-99%. Pt stated feeling a bit better stated regaining sensation in some parts of her face. Pt had stated she had an allergic reaction before to Benadryl and we were unable to administer Benadryl. She was continuously monitored and pt. was able to speak without difficulty. She was provided with few more ice packs placed on her neck and throat. Pt was monitored for 1 hr., she stated feeling better and ice packs were helping, she stated still feeling tingling just in her arms and stated she was regaining sensation to her face. She stated feeling better to go home. Pt assessed again at 5:30pm and vitals read BP-122/74, HR-76, RR-20, O2 Sat-99%. Provider  assessed pt. and pt. was counselled of monitoring symptoms and to report to ER if symptoms were any concern or worsened.  Was recommended to call someone and be picked up as to not drive self. Was released to an acquaintance.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014426 with exp. 14-JUN-2018 and lot # L014426 with exp. 03-AUG-2018 (doses and route were not provided). The vaccines were exposed to 15C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 2 had quarter size redness increasing to softball size redness and swelling. Typical reaction in 20% of patients. MD told pt that it was cellulitis and started BACTRIM DS.
After giving patient Janssen vaccine around 12.40pm he started shaking and  lost consciousness for less than a minute, we called  911 but patient's parents were on the phone with them already, so we cancelled our call, his blood pressure was 97/57 and heart rate 47, we laid him on the floor and elevated his feet, when paramedics arrived he was feeling better and his vitals were stable. Patient's father( who is a doctor and was present at the moment) did not want the paramedics to take him to the hospital.