chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 9 year old male with no past medical history and no known drug allergies who on 2/27/96 in the PM was vaccinated SC with a first dose of varicella virus vaccine live (lot # 612218/1128B). There was no illness at the time of vaccination. Concomitant therapy that day in the PM included a dose of MMR (lot # 614838/1428B). On 3/15/04 in the PM the patient developed a total of 88 lesions per report of the mother. Subsequently, the patient recovered on 3/22/04. There were no relevant diagnostic tests or laboratory data. Additional information has been requested.
On 6/2/21 I got a severe pain starting in my left side and wrapped around my back.  Went to ER. Was told I had pooled blood around my left kidney.  The doctors still haven't figured out why.
This is a spontaneous report from a contactable physician via Pfizer Sales representative. A 2-month-old female patient received the first dose of PREVNAR 13 on unknown date. After vaccination, she had an apnoeic episode. At the time of this report, the outcome of the event was unknown. Follow-up (20Dec2013): Follow-up attempts completed. No further information expected.
Myalgia, NauseaVomiting, Chills, fatigue Narrative:
patient has redness & swelling on both shoulders, painful & hot to touch. a day after vaccines administer
received Flublock Quadrivalent instead of the Fluzone Quadrivalent/no ae; Flublock Quadrivalent instead of the Fluzone Quadrivalent/no ae; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is a linked case with 2019SA339321 (same reporter).  This case involves a 15 years old female patient who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) lot QFAA1923 of Expiration date:30-Jun-2019 via unknown route in right arm on 04Nov2019  instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, vaccinations, family history not reported.  It was a case of actual medication error due to wrong vaccine administered and product administered to patient of inappropriate age.  At the time of report no 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 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.
This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness, arm swelling and vomiting. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752229A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Narrative:  Patient is a 61 y male. Died on 7/11/2021. The patient received COVID vaccines on 3/23/2021 and 4/20/2021. Patient was currently on a feeding tube and was heavily cared for by his spouse. Vaccines not likely related to the cause of death.
Facility clinic thru Specialty Rx  pharmacy provider gave the resident a booster Pfizer vaccine in the left arm  6 inches below the acromion process, which is below the deltoid muscle. The injection went into the tissue below the deltoid  resulting in pain, discomfort, redness, bruising, and warmth to area from site of injection extending  past the elbow. The  attending physician examined the resident and ordered Keflex 1000mg every 12 hours for 7 days, for a diagnosis of cellulitis.
I don't have my menstrual period since the last dose of the vaccine October 2021.; Dose received: 3; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient. A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: 30155BA)at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: E11284), administration date: 28Dec2020, when the patient was 28 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), administration date: 15Jan2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "Dose received: 3"; AMENORRHOEA (non-serious) with onset 07Oct2021, outcome "not recovered", described as "I don't have my menstrual period since the last dose of the vaccine October 2021". The event "I don't have my menstrual period since the last dose of the vaccine October 2021." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that pregnancy test was all negative.  No follow-up attempts are possible. No further information is expected.
Patient stated that she developed Purple bruises on her left breast  which was eventually diagnosed as Mondor's Disease as per her physician as a result of receiving Shingrix.
Unable to go to sleep at bedtime due to sudden onset of shortness of breath.  Sat in recliner and symptoms resolved in 1.5 hours.
patient received PENTACEL and VAXELIS at the same time with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old female patient who received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (MENIGOCOCCAL PROTEIN), Pertussis vaccine Acellular 5-Component, Polio Vaccine INACT 3V (VERO), Tetanus vaccine Toxoid (VAXELIS) at the same time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine INACT 3V (VERO), Tetanus Vaccine Toxoid (Vaxelis) and Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) both for Prophylactic vaccination.  On 19-Jul-2023, the patient received 0.5ml dose (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ842AA and expiry: 22-Feb-2024 via intramuscular route in the right vastus lateralis for immunization and at the same time the patient received Vaxelis with no reported adverse event (vaccine coadministration) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event vaccine coadministration.
Fever of 102 F - 103 F. Jerking in sleep. One day - Motrin/Tylenol was given.
tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
Pt  presented for Bivalent Toddler Vaccine.  Pt was administered Monovalent Toddler Vaccine.  No adverse reaction reported.
Injection site pain,tiredness,headache,muscle pain,chills,joint pain,swelling,redness,nausea,feeling unwell,arm pain
1:30 pm immunizations given. 1:35 wheals noted on right sore arm, called NP to room. Noted 3 wheals in succession ranging in size from 8 mm to 20 mm, surrounded by erythema and blanching. 1:45 pm HR 88, B/P 111/72, T 98.3. 25 mg BENADRYL given at 1:37 by NP. 1:45 Heart RSR/RRR, normal S1, S2, no murmurs; Lungs: Clear to auscultation bilaterally, patient positioned on exam table/bed at 45 degrees HOB elevated. Alert and oriented X 3.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same source. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014. The nurse stated that one dose of GARDASIL (Lot#H020901, expiration date 05-JUL-2014, dose not reported) that was exposed for 8 hours to highest temperature of 9C from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
She planned to get the 2nd vaccine, but she is unable to the get it; Breaking out with cold sweat; Shaking like a junkie; Feels just as bad as the vaccine as I did with COVID; Loose bowels; So sick; Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels) and ILLNESS (So sick) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B2 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Degenerative disc disease (L4-L7).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels), ILLNESS (So sick), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). On 22-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She planned to get the 2nd vaccine, but she is unable to the get it). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 22-Jul-2021, PRODUCT DOSE OMISSION ISSUE (She planned to get the 2nd vaccine, but she is unable to the get it) had resolved. At the time of the report, HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels), ILLNESS (So sick), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR received contain significant information,updated outcome of all events from unknown to recovered and an event missed dose added.
Body aches, chills, headache, malaise (significant enough for me to be unable to work) began within 24 hrs after injection and lasted 36 hrs.
Information has been received from a medical assistant via representative for Immunization program referring to unspecified multiple patients of unknown age and gender. On unknown dates in October 2016, the patients were vaccinated with doses of VARIVAX (lot # M009765, expiration date 23-FEB-2018, dose, route not provided). That vaccine had been maintained at proper temperatures except there was missing data from logger for one week in October 2016 and unspecified doses might have been administered with no adverse effects. This is one of several reports received from the same source. Additional information has been requested.
After the second dose, I started feeling like I had the flu for 24 hours, I missed a day of work. Then I noticed my heart racing continuously. Starting in the beginning of  May 2021, I started having chest pain. I went to my primary care Dr. office on May 12,2021 . She performed an EKG and suggested I see a Cardiologist. The next day I was in the Emergency room at Hospital. There I was Diagnosed with Pericarditis. I was referred to Dr. Cardiology. He performed a Echocardiogram at hospital. He confirmed and diagnosed me with Pericarditis. The time course was Started in May 2021 and I an still under treatment for this condition as of this day. I am feeling better but I have missed a some time from work and I have incurred Medical bills. I feel this may caused by the Vaccine , I tested  negative for covid.
Numbness in L arm, dizziness, nausea, fever 102 degrees. Decrease BP.
Celluitis/induration to right tricep area (4 x 3 cm) approx 1-2 days post VARIVAX #2 treated with BENADRYL x 3 days and KEFLEX x 1 week.
Approximately 7 to 10 days after receiving Covid booster vaccine, I develop a body encompassing hive-like rash.  It starts on my stomach, proceeds to spread to legs, thighs, etc.  Large, red splotchy areas.  Very itchy.  This also happened after my 2nd (Pfizer) shot.  At exactly the same number of days past receiving the shots.
I woke up with sharp shooting pain on my right side and was unable to move, kept vomiting and very lethargic. This happened at about 6 am.  I had to be taken to the hospital immediately and was diagnosed with an appendicitis after an ultra sound and two CT scans. By 6 pm that day, I was being taken in for an emergency appendectomy.
Information has been received from a PharmD. concerning a 5-year-old male with an allergy to porcine and bovine gelatin who in approximately 2006 " about 3 years ago" was vaccinated with a dose of MMR II. In approximately 2006 "about three years ago" the patient experienced hives, nausea, vomiting, diarrhea and difficulty breathing post vaccination. The patient sought medical attention via an office visit and was treated with BENADRYL and a steroid. On an unspecified date the patient recovered.  A product quality complaint was not involved. Additional information has been requested.
I was having a bad headache like something was stabbing and pinching on the left side of my brain. About four days later I was having more pain around my left eye near my eyebrow. Then a rash appeared on the left side of my forehead near my hairline. That moved down toward my eye, and this led me to go to the ER. After looking at the rash they also called an eye doctor to take a look at me as well. They then told me that it was Shingles, and I was given some pain medication and then and medication for the shingles and an ointment for my eye. I had a follow up with the eye doctor to check my eye and at that time it was painful and swollen. The swelling is better along with the rash but I still have the pain in my head.
I experienced a full-body tingling/vibrating feeling. This includes my face/head. I also experienced vomiting and diarrhea, and extreme anxiety.
Report 20010071841 described sore shoulder (injection site) in a male of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) for the prophylaxis of hepatitis B. The vaccinee had no known drug allergies. Medical history and concomitant medications were unspecified. On 02/16/2001, the vaccinee received his 1st left deltoid "adult" dose of Engerix-B. On 02/17/2001, the vaccinee complained of soreness in his left shoulder and unspecified "problems with rotation." As of 03/19/2001, the outcome event is unresolved.
Leg muscles are tired and weak. Started day after second dose vaccination. Still an issue (6/3). Had to reduce activity level by at least 50%. Weakness has been constant (not getting better or worse) since it started.
tested positive for covid-19; tested positive for covid-19; Dementia; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for her sister that a 73-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient had tested positive for the third time for the COVID virus. The patient had Dementia in Jan2021. The patient had first dose of BNT162B2 on 03Jan2021 and tested positive for COVID on 18Jan2021. Patient was scheduled for the second dose for Thursday 28Jan2021. Since patient had an active case with symptoms the reporter was assuming patient won't get the second dose on 28Jan2021. Since patient had already had the first dose, currently in quarantine until after 01Feb, the reporter wanted to know if patient would have to start all over with getting the vaccine. The patient underwent lab tests and procedures, which included COVID virus positive twice on an unknown date, positive once on 18Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
p/vax pt reported feelings of facial hemiparesis that progressed over the next 24hr;tx for a foreign body irritation in rt eye & w/pred for a dx of Bell's Palsy;pt had a dec in eye pain & some improvement in rt side facial paresis; It was reported, "A member of the Air Force Reserves, as part of his duty requirement, was given influenza vaccination on 04 October 1984. The following day, he reported feelings of facial hemiparesis that progressed over the next 24 hours. He was treated for a foreign body irritation in his right eye and with Prednisone for a diagnosis of Bell's Palsy. As of 17 October 1998, he had a decrease in eye pain and some improvement in right-sided facial paresis, which was still obvious."
October 22: Woke up with body aches. Went to bed early due to it. October 23: Went to ER for migraine and body aches. Was treated for migraine and blood was taken. Had fever and was told it was viral. October 24: Returned to ER for severe body aches. More labs were ran and I was kept for observation that night. I was given Morphine and NORCO for pain. October 25: Was discharged to go home. Once home body aches crept back. October 26: Woke up unable to move or walk. Attempted to walk but passed out and was taken to ER.
Severe headache started about 24 hours after shot.  Very dizzy, nauseous, exhausted with a constant headache that lasted about 24 hours. The headache went away after 24 hours. I put an icepack on my head, took advil and slept. I am still experiencing dizzy spells throughout the day two weeks later. If they are still happening in a week I am calling my doctor .
The patient passed out a couple of minutes after receiving the vaccine.  I asked if he had had any reaction or problems to vaccines or shots before and him and his parents and him both said no.  After he passed out they told me he was mildly autistic and had passed out at the doctors office when getting a shot and in biology class dealing with dissection.  They repeatedly said it was just anxiety.  After laying him down and elevating his feet he started feeling better.  At no time did he display any breathing problems or any anaphylactic symptoms.  And he did not hit anything when being laid down.  I monitored him for 30 minutes and let them go after they said he was 100 percent feeling fine and he seemed like he was ok.
No additional adverse symptoms were reported; a patient was inadvertently given a dose of MMR II on 12/27/2019 after its expiration date; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 27-DEC-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N025892, expiration date 19-SEP-2019; route, strength unknown), albumin status rHA (recombinant Human albumin) for prophylaxis after its expiration date (expired product administered). No additional adverse symptoms were reported. No other information was available.
administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient don't have acute illness at the time of vaccination and up to one month before. Patient reports no adverse events from the vaccine that was took on 06-Apr-2022. The vial did not undergo any temperature excursions. On unknown date the vial was initially stored in the refrigerator. Patient had never been diagnosed with or tested positive for COVID-19. The result of stability study shows full activity against COVID-19.  No treatment medication was reported.   This case was linked to MOD-2022-541343 (Patient Link).