chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed Vocational Nurse referring to multiple patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L001335 with expired date 13-JAN-2017; lot# L006386 with expired date 25-FEB-2017; lot# L018002 with expired date 19-MAY-2015; lot# L001333 with expired date 13-JAN-2017; lot# L015047 with expired date 19-APR-2017; dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
PATIENT CALLED PHARAMCY STATING RASH ALL OVER BODY. TOOK BENADRYL. ADVISED PATIENT TO CONTINUE TAKING BENADRYL AS DIRECTED ON PACKAGING. WILL FOLLOW-UP WITH PATIENT TOMORROW MORNING. DISCUSSED SIGNS/SYMPTOMS IF PATIENT NEEDS TO GO IMMEDIATELY TO THE HOSPITAL.
initial reaction urticaria followed by arthralgia of the hands, feet, knee, wrists, ankles, & hips; sx resolved;
Swelling, redness, pain in left arm. Hot to touch 70mm x 6 mm
This spontaneous report has been received from a pharmacist referring to an approximately 72 year old female patient. The patient did not have drug reactions or allergies history. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. In approximately 2009 (reported as "7 or 8 years ago"), the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot number and expiration date was not reported) for prophylaxis. Right after vaccination, when the patient walked out of the doctor's office, she got all flushed and her hands started to swell and then the skin on her hands started to peel off. The patient was seen by an unspecified health care provider "at that time of the incident" and no treatment was given. The reporter mentioned that the patient was fine now but he did not know when she recovered. At the reporting time the causality assessment between PNEUMOVAX 23 and the events was not reported.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 23-SEP-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Hospitalized 11/18/2021; COVID-10 positive 11/18/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 11/18/2021 Discharge Date: Nov 23, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 virus infection [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] AKI on CKD 3a   HOSPITAL COURSE: Patient is a 90-year-old woman with history of hypertension, hyperlipidemia and type 2 diabetes with vaccinated with Moderna in February/March this year but has not received a booster shot who present with a 2-3 days of severe body aches, fevers, cough and diarrhea.  She was found to be COVID-19 positive.  Patient was hypoxemic at 86% on room air and was placed on 2 L of oxygen.  Patient was admitted for COVID-19 pneumonia was placed on IV Decadron and remdesivir. She improved with a supportive treatment.   Patient was also found to have mild Aki likely prerenal in setting of GI lost and use of losartan and MAaxzide.  This medications were held and she was status post gentle IV fluid resuscitation which resulted the improving renal function but never back to her previous baseline of last year. I suspect this is likely her current baseline. She will need a follow up BMP in 3 days.   Patient was discharged in stable condition.
This spontaneous report as received from a 59 year old female patient, with no pertinent medical history and no drug reactions/allergies, refers to herself. On 01-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX lot # J000853; expiring 23-APR-2014 (dose and route not reported). No concomitant medication was reported. In approximately July 2013 the patient experienced a rash and extra mucus in the throat after receiving the ZOSTAVAX. The patient also stated that she suffered from a swollen face and injection site irritation after receiving the ZOSTAVAX. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient saw the doctor for medical attention. The adverse events did not improve and the patient's outcome was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
Client presented for first Moderna Covid Vaccine.  Administered without incident but while waiting in observation area, reported lightheadedness. Client states she has low iron, "just got my period" and was very nervous about getting vaccinated today. BP 132/80; P 72. Given juice to drink. After 30 more minutes client reported no longer feeling lighted headed and left in care of her adult son.
Baby awoke from nap, cried, then had a blank stare and began jerking. She did not respond to any stimulation. This reaction went on for several minutes, stopped, and then began again for a minute. No fever present during this reaction, baby was cold but did not turn blue. This was witnessed by the mother, father, and both grandparents. Mother called the ER and they instructed parents to bring baby in. Baby was seen in the ER, observed for about 1 hour. No further reaction observed and baby was discharged to hom with instructions to frequently monitor baby.
Pt recvd vax &  exp arthralgia, myalgia, muscle weakness, fatigue & malaise; 10SEP93 pulled a muscle in rt groin area while playing football; sx resolved; exp sharp pain; pain migrated to back of the thigh & behind knees;
Patient tested positive for COVID on 12/30/2020. She did not experience COVID symptoms; however, at that time her dementia and weakness progressed.  She passed away on 02/12/2021 at the nursing home facility.
No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 14-OCT-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  On 18-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error). The nurse reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 hours, as recorded by the data logger. There were not any other temperature excursions.   No adverse effects were reported for the patient.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA005831: US-009507513-2003USA005908:
Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product concerning a 19 year old female patient with no pertinent medical history and no drug reactions or allergies who on 20-AUG-2009, was vaccinated with a dose of VARIVAX (Merck) (lot # 664235/0642Y). At time of vaccination, the patient was about 4 weeks pregnant. Her last menstrual period was on approximately 23-JUL-2009, and estimated delivery date was approximately 29-APR-2010. Urine pregnancy test was performed which confirmed pregnancy. The patient had a maternal serum alpha fetoprotein test which came back positive for a risk of Down's syndrome 1 and 5. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering.    Information on the lot/batch number has been requested.
Shortly after getting the shot, while driving home, started to feel chest tightness on my left side. It?s been there for three days now. Feels like a muscle tightness. Gets more intense if I take deep breaths.
0720: pt c/o feeling "faint, lightheaded, dizzy" 10 minutes post second dose of Pfizer COVID-19 vaccine.  pt appears pale and diaphoretic. laid to the ground with bilateral lower extremities elevated above level of heart. pt states he feels better a few minutes after intervention. VS BP 121/76, HR 68, RR 16, SPO2 96 on RA, T 97.9.
Very irregular menstrual cycles following shot. Cycles have been up to 22 days each  month. I have never had a cycle longer than 5/7 days my entire life.
Pt  presented to the emergency department at 2/15 for dyspnea  on exertion, at times patient was given 3 breathing treatments, he was sent  home with prednisone and a Z-Pak, his workup was otherwise unremarkable that  time. The patient returns 2/25 for increasing shortness of breath. The  patient was walking to the bus to get to an appointment here at 1pm, somebody  on the bus notcied he was short of breath and called emergency. The patient states  he is frustrated because he just wants to be able to breath and ride his bike  again. The patient states that his shortness of breath has been getting worse  for the past 2-1/2 years, he states that he now wears oxygen during the day  and he is short of breath even at rest. Patient had several other admissions to hospital throughout year until current hospitalization with + covid infection, hospitalized 12/7/21, admitted to the acute medicine service for acute on chronic mixed respiratory  failure, community acquired pneumonia/Covid-19 infection AKI, and elevated troponin.
his INR measured 2.1 which has been lower than it has been in 5 years; his arm hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date: 31May2021), via an unspecified route of administration (at the age of 74-years-old) on 30Jan2021 09:30 at a single dose in right upper arm for COVID-19 immunization. Medical history included Mechanical heart valve from Feb2000 and ongoing, Parkinson's disease, heart rate abnormal, blood pressure abnormal, penicillin and sulfonamide allergy, cholesterol, and rashes. Concomitant medication included warfarin from 2000 and ongoing for Mechanical heart valve and blood thinner for mechanical heart valve, carbidopa, levodopa (CARBIDOPA/LEVODOPA) for Parkinson's disease, carvedilol for Heart rate, hydrochlorothiazide for blood pressure (unknown, thinks it is blood pressure), simvastatin for Blood pressure or cholesterol, not sure which, lisinopril for Blood pressure, pramipexole for Parkinson's disease, macrogol 3350 (MIRALAX) as Laxative, docusate sodium (COLACE) as Stool softener. The patient previously took BACTRIM and experienced allergies. The patient experienced his arm hurt a little bit on Jan2021 with outcome of unknown and his INR measured 2.1 which has been lower than it has been in 5 years on 01Feb2021 with outcome of unknown. The patient and his wife received the 1st dose of the vaccine this past Saturday, 30Jan2021 and is scheduled to take the 2nd dose on 20Feb2021. He mentioned that his arm hurt a little bit, but other than that he was fine. He has been taking warfarin for 20 years and has been Home Monitoring his INR for 5 years. This morning his INR measured 2.1 which has been lower than it has been in 5 years. His usual range is 2.5 - 3.0 and he is worried that the lower INR might risk him for clotting diseases and a stroke. He is asking if there is an interaction with warfarin and the vaccine and will it be safe for him to take the 2nd dose. He has a mechanical heart valve placed year 2000 that he takes Warfarin sodium daily for as a blood thinner. He reported that today: 01Feb2021 at 09:05 his INR level is lower than he has ever recorded in last 5 years: 2.1. He asked if the Pfizer COVID-19 Vaccine can affect the Warfarin sodium or affect blood thinning. Adverse events did not require a visit to Emergency Room or Physician Office. No hospitalization. No prior Vaccinations (within 4 weeks). No adverse event following prior vaccinations. Years ago, he recovered completely from all medication reactions. Further described as he thinks all the reactions were rashes. Medications he had reactions to include Penicillin, Bactrim and Sulfa drugs.
Severe rigors (chills), severe headache, body turned bright red and hot to the touch, no sleep no fever, touching anywhere on body was painful, sheet and blankets were painful. Next day was better, but at 7PM symptoms began again, not as severe.
My second shot created inflammation in my whole body with worst pain and soreness and aching in neck and shoulders and elbows, lasted for several months. My third shot is creating same reaction.
Nausea and lightheadedness, increased blood pressure 155/101 and heart rate 113.  Pt monitored and BP down to 134/90 feeling better after monitoring.
Redness, slight swelling and tenderness about 1 1/2 inch in diameter of injection site.
Severe dizziness upon awakening, while lying and attempting to rise and while walking, usually first couple of times arising in middle of night and morning.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into narrative: Product complaint investigation results.
RED AT INJECTION SITE, FEEL WARM (DID NOT HAVE FEVER), FEEL SLUGGISH AND FLU-LIKE SYMPTOMS (NOT AS SEVERE AS FLU) , NEEDS NAP, ITCHY PATCH  AT INJECTION SITE 2 DAYS LATER AFTER FEELING BETTER (NO FEVER)
Per medical assistant's chart notes who attempted to administer the Moderna vaccine to patient:  "Patient presents for first covid injection. Upon administration of moderna covid vaccine to the left arm, the integrity of the hub/syringe was compromised. Patient did not receive full dose due to broken syringe leak. As advise by nurse manager and Dr, I was instructed to administer a second vaccine in the right arm, as the left was the unsuccessful site. Patient was educated, and tolerated injection well."  After discussion with medical assistant, less than half of 0.5mL was administered to the patient. Per discussion with Dr and using this link as a guideline, a repeated dose was administered in the opposite arm.
Information has been received from a nurse concerning an 18 year old female patient who on 16-JAN-2009 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (Lot# 661531/1311X). Concomitant therapy included ADACEL and tuberculin purified protein derivative (unspecified). On the same day, the patient experienced syncope after receiving her first dose of GARDASIL vaccine. The patient was seen by a nurse. There were no laboratory or diagnostic tests performed. The ptient recovered shortly. Additional information has been requested.
Injection of SHINGRIX 50 Mcg Inj - rt. shoulder injection, intramuscular. Painful within 30 min and continued to be very painful at site. By next AM I suffered severe pain including: headaches, neck pain and pain continues from head to mid-calf equal to plus 10. Pain was like severe burning on the skin. Pain was exactly like I suffered from actually having shingles. Dr. prescribed strong pain medication and the pain subsided after 4 days. No redness or rash was visible with the pain.
Pt developed an 8cm X 9cm area of erythema on right deltoid area. Area was warm, red and tender to the touch.
Initial information had been received from a 49 year old female patient referring to herself. There was no pertinent medical history and drug allergy. On 02-JAN-2015, patient was vaccinated with the first dose of RECOMBIVAX HB lot # K009505 pediatric dose instead of an adult dose, intramuscularly of Hepatitis B (underdose). On 04-FEB-2015 she received her second dose of RECOMBIVAX HB (lot#, dose and route unknown). On 22-JUN-2015, the patient received her third dose of RECOMBIVAX HB (lot#, dose and route unknown) (inappropriate schedule of vaccine administered). There was no concomitant medication. On an unknown date after the series were complete (on JUN-2015), the patient's titers were test to verify immunity. The patient was currently not considered immune to Hepatitis B due to her "extremely low" titer count. The action taken and outcome of the events were unknown. Additional information has been requested.
about 12 hrs adm of vax, pt stared high pitched cry w/stiffening; cryed off & on w/high pitched cry for 3 days; seen by MD 3rd day & given APAP; p/this pt had diarrhea x 5 days w/loose stools cont for 1 mo;
Information has been received from a consumer concerning a 65 year old female who in July 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Approximately 2 to 3 weeks later the pt experienced extreme fatigue. It was reported that blood work suggested symptoms associated with renal failure. Unspecified medical attention was sought. Additional info has been requested.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Red swollen lump at injection site. Very tender. She is going to doctor to make sure its not a blood clot.
Patient said she had swelling near the injection site. The following day the swelling went to bicep area, and then the day following the swelling went near her elbow. I found of the incident 3 days after the patient got the vaccination. I called to follow up and her symptoms are much improved then they were in previous days.
Information has been received from a healthcare worker concerning a 54 year old male patient, with no medical history reported, who in the past 2 weeks was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (Lot #651357/0391F). Subsequently within a few days of receiving the vaccine, the patient developed a local injection site reaction. The patient possibly was seen in the office for symptoms. No product quality complaint was involved. Additional information has been requested.
On Friday 12/1/17 patient received FLUZONE HD in her right arm. Patient had never had a history of reaction to a flu shot. The patient and her daughter called on 12/19/17 to let us know that she had a reaction to the shot that was described as followed. By Sunday 12/3 she was not feeling well/stomach issues. On Monday her face was red, by Tuesday her face was swollen/red/peeling. She went to her doctor in town on 12/6/17 who did not think it was related to the flu shot. He thought she just had a skin infection, wrote BACTRIM DS. On Friday 12/8/17 the swelling redness was worse, itching, flaking, spread from her face to her ears. She went to the ER where the doctor there thought it was a reaction to the flu shot and prescribed her MEDROL dose pack and Hydroxyzine. She has since finished that course of therapy and her symptoms have basically resolved by now. This is all according to the conversation I had with her daughter on 12/20/17 2:00p. The daughter wanted to make sure we were aware of the situation, and I informed her that we would let her PCP know of the occurrence. She was pleased by this. Patient's PCP was notified by myself to representative 12/20/17 2:13p to describe that she had reaction to the flu shot given.
nauseated; having joint pains; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated) and ARTHRALGIA (having joint pains) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced NAUSEA (nauseated) and ARTHRALGIA (having joint pains). At the time of the report, NAUSEA (nauseated) and ARTHRALGIA (having joint pains) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment information was provided.   This case was linked to MOD-2021-308441 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: follow-up document received and include no new information
(R) arm hive at site of MMR injection-Dr had BENADRYL administered and ice packs applied to site- ?egg allergy patient is being referred to allergist for testing