chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a serious observational study case, initially received from other health professional on 15-Feb-2019, concerning a 31-year-old, adult female pregnant subject of body weight: 222 lbs, height: 62  inches and body mass index (BMI): 40.6, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject had 1 previous pregnancy with preterm-term live birth. There was no history of maternal or paternal congenital malformation. The subject had not used tobacco, alcohol or elicit drugs during pregnancy. The subject's current conditions included late prenatal care, acid reflux, depression, anxiety and Rh-negative. The subject's concomitant medications included RHoGAM (anti-D immunoglobulin) for RH negative and Prilosec (omeprazole) for acid reflux. The subject's last menstrual period (LMP) date was 15-Apr-2018. On 20-Sep-2018, at gestational age of 22 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252226, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On 23-Sep-2018, maternal Serum Alpha-Fetoprotein Screening (MSAFP) was performed and no major congenital malformation noted. On 02-Oct-2018, ultrasound was performed, and no major congenital malformation noted. On 08-Jan-2019, 3 months and 19 days after vaccination, the subject experienced gestational diabetes mellitus and anaemia. The subject received treatment drug metformin (500 mg, oral, 2 tablets qd, from 24-Jan-2019) and Humulin (insulin human, insulin human injection, isophane, 100 units, qd, subcutaneous, from 31-Jan-2019) for gestational diabetes mellitus. The subject had not yet recovered from the events. The subject's estimated delivery date (EDD) was reported as 25-Feb-2019.; Reporter's Comments: A 31-year-old female pregnant subject with late prenatal care experienced gestational diabetes mellitus and anaemia, 3 months and 19 days after receipt of study vaccine. Considering the implausible temporal relationship between vaccination and reported events and no evidence for a biological mechanism that could cause the events, the events were assessed as not related to the study product. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The reporter assessed the case as serious (medically significant).
Patient found unresponsive to verbal stimulus in chair at her desk with blank stare. Color pale. Lowered to floor. Patient breathing, eyes opened & gradually became alert & oriented. Seen at ER. No further intervention received.
Developed redness, hot, swollen area below the injection site.  Pt did not complain of fever.  Redness and soreness of the arm was getting worse.  Given Medrol Dose pack, Benadryl, and Keflex.
It was reported that a 39 year old male received Fluzone SV '98-'99 USP on 11/4/98 and on 11/6/98, the pt complained of uncontrollable body shaking, "left hand felt asleep," and shortness of breath. Additional information received via phone conversation on 11/18/1998, it was reported that the pt is 95% better as of 11/18/98.
Initial report received from a healthcare professional on 14 June 2012. A 16-year-old male patient, who had no known allergies or concomitant medication and whose medical history included ADHA, received a dose MENACTRA on 7 June 2012. On 7 June 2012, same day of vaccination, the patient developed urticaria with itchy red swollen hands and soles of the feet, swelling and reddening of palms of hands and soles of feet on an off. It is tender to touch and swelling and redness is progressing up the arms. The patient received ALLEGRA during the day and BENADRYL at night as corrective treatment. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received on 14 September 2012: The patient did not receive any other vaccine within 4 weeks of the MENACTRA. The patient was receiving STRATTERA and RAPIDUS since as unknown date. The patient visited an allergist and was diagnosed was found to have urticaria and serum sickness type reaction (Arthus type reaction) to MENACTRA. He was treated with oral steroids after which the patient was fine.
Experienced fatigue and headaches beginning approximately 24 hours after vaccine injection. The fatigue and headaches were most severe on the between 24-33 hours after injection then gradually subsided until adverse events were eliminated on Day 3, approximately 57 hours post injection. No treatment was taken to lessen side effects, simply rest.
2 days after the vaccine (NOTE - he got the high dose flu at the same time) he developed generalized weakenss, low grade fevers, no enerty and feels poorly
Shoulder pain ( L arm, injection site); The first night he couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (The first night he couldn't sleep) and VACCINATION SITE PAIN (Shoulder pain ( L arm, injection site)) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced INSOMNIA (The first night he couldn't sleep). On an unknown date, the patient experienced VACCINATION SITE PAIN (Shoulder pain ( L arm, injection site)). At the time of the report, INSOMNIA (The first night he couldn't sleep) and VACCINATION SITE PAIN (Shoulder pain ( L arm, injection site)) outcome was unknown.            Concomitant information  was Type 2 diabetes medicine.  Treatment information was not provided   This case was linked to MOD-2021-032275 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received and contain non significant information.
Information has been received from a pharmacist concerning an 88 year old female who on 06-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650456/0974P).  Subsequently, the patient developed large raised welts at the site.  No prescription drug treatment was required.  The patient's outcome was unknown.  No further information is available.
Hematochezia (Blood in stool for roughly 48 hours after first dose of vaccine) Patient had no history of hematochezia. No diet changes or medications introduced. Breast fed since birth. Administered with Pneumococcal (PCV-13) through injection to left thigh on the same day.
Start around 2 hours after vaccine. The muscle was twisting. After 15 minutes, the twisting move throughout his body.  These symptoms lasted for about 36 hours. I took to him to the clinic on Monday morning. They did blood work on him. She did a physical exam for neuralgic exam.
Patient reported feeling light headed approximately 8 minutes after receiving the vaccine, then fainted.  Patient came to 2-3 minutes later.  Patient was provided water and orange juice, as he had mentioned he had only had a very small breakfast (one poptart).  Patient says he has not fainted post-vaccination before, but has fainted before after getting his blood drawn.
Information has been received from a physician concerning a female who was vaccinated on 16-APR-2007 with Rotateq (Lot # 65721/0768U) first dose. Concomitant therapy included Pediarix, Comvax, Prevnar. On an unspecified date the patient developed blood in their stool. The patient was referred to a GI doctor where the patient is currently being monitored. It was reported that at the time of the vaccination, the mother was breast feeding and was on a strict diet. There was no product quality complaint involved. Additional information has been requested.
2/9/2021 Expired at facility.  Several weeks prior with several medical and mental health issues as noted prior. 2/4 began with increased lethargy and somnolence. Medications being held per MD. 2/5 CBC WNL, BUN/Cr 38/1.23 GFR 41 2/5 Admitted to Hospice services on 2/5.
I had the vaccine on 11/7/2021. I was told they were only giving the MRNA so I went to get the J&J.  Then on the evening of 11/8/2021 I started having chest pains just under my heart to the point I was holding my chest.  later that evening I started having a rash, itching (internal and external), coughing, wheezing, excess phlegm, etc.  the next morning everything was gone except the chest pain.  I contacted a Dr. who told me it was probably a delayed reaction.  It went away by 1pm that day on 11/9/21.  It came back a few days later and has been periodic ever since.  It has been more frequent lately and the sharp pain is always in my heart or the area of my heart.  I had an EKG and I have had a follow up appointment at Doctor Office.  I have more appointments coming up regarding this issue.
Sore throat, cough, swollen lymph nodes under left arm and throat.  Tightness in chest.
Throughout that afternoon, I felt more tired and achy. By 530pm, I had a fever of 101.3 and bad muscle aches. By 10pm, my fever had risen to 101.4 and I had aches and chills.  I took Advil and went to bed. The next day, my fever started off lower but stayed between 99.5 and 101 all day.  Muscles were extremely painful and I slept a lot.  Everything was the same on 6/27, and I began to feel nauseated. In the evening my bowels became loose.  All day on 6/28, I ran a fever up to 100.3 and had nausea and diarrhea all day (at least 15 times). Soreness and aches continue.  I did not hurt this much when I had pneumonia or when I received my first pneumonia vaccine. The potential benefit of this drug is NOT worth what I have been put through the last 4 days.
This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Annoying headache; sinus congestion; cough; fatigue; This is a spontaneous report from a contactable 69-year-old non pregnant female Other Health Professional reported for herself that:A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN,) via an unspecified route of administration on 03Feb2021 12:30 as SINGLE DOSE for covid-19 immunisation .Medical history included  from an unknown date and unknown if ongoing. On 03-FEB-2021 15:00 patient experienced  the Annoying headache and sinus congestion and cough and fatigue and outcome of the event was not recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
Stroke; Side effects; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and ADVERSE EVENT (Side effects). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and ADVERSE EVENT (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.  Company comment: Very limited information regarding these events has been provided at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time.
I was experiencing mild symptoms with coughing and low-grade fever.  It felt like I had a bad cold. I saw my provider and was prescribed Paxlovid.
Pt immediately got black and blue at the injection site. Pharmacist contacted patient later in the evening and the patient stated it was red and inflamed. Patient stopped in the pharmacy the next day (Jan 23, 2014 around 4pm) and the injection site was red, warm to the touch, & approx. 2 inches in diameter. Advised the patient to contact MD if the site was painful or it got worse.
Pt reports pain at injection site of pneumonia vaccine and syncopal episode evening of immunization.
Presented to office next day with temperature of 102.9, rectal.  Had fever of 104, rectal during the night.  Cheeks flushed, fussy.  Diagnose with vaccine reaction.
devel fever of 101.9 approx 14hr p/vax given APAP q 4hr but fever persisted @ 101.2;event lasted until 12FEB97 AM;mom states fever not as high & didn't last as long;
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Lot number: HG2649), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 0 breast cancer", start date: 2019 (unspecified if ongoing). No Known allergies. Concomitant medication(s) included: TAMOXIFEN taken for breast cancer; IBUPROFEN. Vaccination history included: moderna (Vaccine administration date: 22Nov2022, Vaccine lot number: A57147B, Vaccine dose number: 5, Vaccine location: Left arm), administration date: 22Nov2022, when the patient was 55-year-old, for Covid-19 immunization; Covid-19 vaccine (Dose 4 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2 Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29Oct2023) Positive, notes: Retested positive on 29Oct2023. Retested positive on 29Oct2023, symptoms returned 27Oct2023. The patient received PAXLOVID as Treatment from 15Oct2023 to 20Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
This spontaneous report received from a other health care professional (reported as pharmacy manager) refers to a patient of unknown age and gender. No information about medical history, concurrent conditions were reported. The reporter stated that on an unknown date ZOSTAVAX (Lot K016325, expiration date 24-DEC-2015) strength, route subcutaneous) had began to liquefy causing the patient miss vaccination. No concomitant therapy was reported. No adverse effects reported. Product quality complaint has been filled. The outcome of events reported is unknown. The patient had not sought medical attention. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Additional Details: Patient appeared to have vasovagal type reaction. He felt faint and broke out in a severe full body sweat.  He recovered after sitting for about ten minutes and drinking a bottle of water.
This spontaneous report was received from a nurse refers to a 4 year old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUL-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K016129, exp. date: 23-SEP-2016) (dose, strength, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
ACHINESS; CHILLS; HEADACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced achiness, chills, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, achiness and chills was not reported. This report was non-serious.
Child received IPV on 6-14-10 and on 6-19-10 mom noticed a faint rash on (R) leg at injection site. He had a 3-day hx of low-grade fever and diarrhea. PE-generalized erythematous macular, blanching rash.
recent Covid diagnosis on 01/05/22 ( treated with 2 rounds of antibiotics) who presented to ER with c/o cough, fatigue, and SOB. CTA chest in the emergency room showed atypical multifocal pneumonia with no PE. Received dexamethasone. Mild hypoxia. Discharged home on home Oxygen.
3 days after vaccines given noted swelling of lymph nodes under right arm. Occurring 4-6-15. This AM 4-7-15 noted right side pains and sinus pain. Dizziness that is improving over the morning. No fever.
aches; fatigue; fever of 100.4-100.2 range; cough; A spontaneous report was received from a female nurse  concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced cough, fever, aches and fatigue.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020 the patient developed a cough. On 1 Jan 2021, the patient developed a fever 100.2-100.4°F and on an unknown date patient experienced aches and fatigue. Treatment for the event included paracetamol and ibuprofen.   Laboratory details included patient's body temperature which ranged between 100.4 to 100.2 degree Fahrenheit on 1-JAN-2021 and 100.3 degree Fahrenheit.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed a cough, fever, aches and fatigue, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received vaccine at his high school in preparation for college dorm life.  Four hours after vaccine administration headache began.  Two hours later, patient had subjective fever and malaise.  Took ibuprofen 800mg then slept through the night.  Awoke with severe headache, fever (38.6 in ED), muscle stiffness so was brought to emergency department by his mother. Patient stated he did not receive VIS with vaccine administration. In the ED, again had fever as above, headache, and neck stiffness, therefore had lumbar puncture to rule out meningitis (results below). Later discharged from emergency department to home.
Day after Td vaccine, left arm very sore. By the second day could not raise that arm and also had redness and warmth on arm size of a thumb, 2 days after vaccine. On 01/16/05, started itching and had whelps develop, along with some shortness of breath during the next night. On 01/17/2005, face started swelling on right side & spread to entire face including lips, eyes and nose. Seen by PMD on 01/19/05, treated with Prednisone dose pack.
Arm itching and swollen, took benadryl, thought would help, got shaky, went to bed. Felt nauseous during night, syncope episode twice. Fever 101F. Arm does not itch this morning, still swollen, still has fever and shakes.
left basal ganglia ischemic cerebrovascular accident; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 26-NOV-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered left sided weakness and confusion. She was hospitalized and diagnosed with left basal ganglia ischemic cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of cerebral ischaemia was reported as not recovered/not resolved. The reporter considered cerebral ischaemia to be related to Zoster Vaccine Live (ZOSTAVAX).     Left basal ganglia ischemic cerebrovascular accident was considered to be disabling.  Upon internal review, left basal ganglia ischemic cerebrovascular accident was considered to be medically significant.
4 hrs p/receiving MMR & HIB devel edema of lips, earlobes & urticaria of trunk/extremities, Epi x 1 dose, po DPH given;
Headache, fever, chills, GI upset with diarrhea that persisted awhile longer and I missed two days of work.