chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 15 year old female patient. The patient had none pertinent medical history and developed none drug reactions or allergies. On 15-SEP-1999, the patient received first dose of M-M-R II HSA (dose, route of administration, lot # and expiration date were not provided). On 21-OCT-1999, the patient received her first dose of (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not provided). On 09-SEP-2003, the patient received a second dose of M-M-R II (dose, route of administration, lot # and expiration date were not provided). On 03-JUL-2008, the patient received a second dose of (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not provided). On 09-JUN-2014, the patient had titers drawn on and the results of the titers showed that the patient was negative rubeola and negative varicella. The reporter stated that the patient was administered a dose of (Oka/Merck) PROQUAD on 12-JUN-2014 due to the patient was negative rubeola and negative varicella. The outcome of the events was unknown. The relatedness between the event and the vaccination with suspect vaccines was unknown. This case is linked with MARRS#1407USA005462 and 1407USA001009 (same reporter linked). Additional information has been requested.
12:30 Hives developed on right shoulder.  C/o warm ear (right) 12:50 and itchy all over.  ZYRTEC - given in office 10 mg. orally.  20 mins. later hives on abdomen, hands - back bilaterally.  Dr. in to examine patient VSS-Pulse ox 99%. Peak flow 550.  Epi. given subq left arm.  .03 @ 1310.  Hives and conditioned improved.
slept a lot; lower back hurt; tested positive for COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), DRUG INEFFECTIVE (Lack of drug effect), SOMNOLENCE (slept a lot) and BACK PAIN (lower back hurt) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced SOMNOLENCE (slept a lot) and BACK PAIN (lower back hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and SOMNOLENCE (slept a lot) and BACK PAIN (lower back hurt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test positive: positive (Positive) positive.         Concomitant medications include  Ace Inhibitor.  It was reported that patient symptoms lasted for about a week, after which he felt fine. Patient symptoms were very mild as well.  Company Comment: This case concerns a 73-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 6 months after the second dose of vax. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of vax is not affected by this report. Drug ineffective was considered as an additional event.; Sender's Comments: This case concerns a 73-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 6 months after the second dose of vax. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of vax is not affected by this report. Drug ineffective was considered as an additional event.
Information has been received from a nurse concerning a 13 year old female who 11-SEP-2007 was vaccinated with a 0.5 ml dose of GARDASIL. Concomitant vaccination on the same day included a second dose of Varicella virus vaccine live (MSD). On 12-SEP-2007 the mother of the child called the doctor office stating the child had nausea and was vomiting. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Swelling/pain size of softball at injection site also got shingles at injection site and between shoulder and neck - swelling has gone down, but rash is still present.
Currently a 33-year-old WM. Patient history reveals patient first reported symptoms of hyperglycemia around mid-December while at work, but no records are available from that visit. Pt then presented to office on 20 Dec 2006. (Glucose level was 262 and HgbA1c was 12.1). At that time, he reported approximately 4-week of polyuria, polydipsia, blurred vision, and weight loss (approximately 10-15 pounds over previous month). (This note is not visible in electronic medical records, but lab result dates and other notes from his medical records support this history.) While on vacation, on 31 Dec 2006, pt sought evaluation at clinic for continued weight loss and new onset nausea and vomiting. His presenting BG level was 521 and his pH per ABG was 7.25 and UA with positive ketones and glucose. He was admitted to clinic for 5 days with diagnosis of Diabetic Ketoacidosis (DKA). In early Jan 2007, his C-peptide level was 0.6 (1.1-4.4). Daily Lantus with supplemental Aspart were initiated. Pt received diabetes self management education, he was followed up through Internal Medicine and Endocrinology at hospital.
Pt's heart rate increased exponentially post vaccine (169). EKG was done at office and patient was sent ER through ambulance. Pt has hx of panic attacks with similar sx.  Pt was monitored for 15 minutes, heart rate dropped to 125. SEnt to ER for fruther evaluation. Intensity Min-0.
Initial unsolicited report received from a nurse on 04 November 2015. This case involves a 06-year-old male patient who was vaccinated with 0.5 ml dose of Fluzone quadrivalent multi-dose vial (batch number: UI443AC, expiry date, dose, route of administration were not reported) in left deltoid on 28 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed severe swelling of left upper arm with warmth and redness. It was reported that, reaction was seen on 30 October 2015. The patient's laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
No adverse event for the child.  State stock influenza vaccine erroneously given to child with insurance other than state insurance.
This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-FEB-2017, the patient was vaccinated with a dose ZOSTAVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient returned to the pharmacy on 15-FEB-2017, because he/she experienced huge red rash at the injection site. The outcome of the events were unknown. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Tachycardia. Redness along upper back/neck and swollen lips. Patient taken to the ER and symptoms began improving.
Per the husband, the patient was walking and suddenly said she didn't feel good. Her speech became slurred and she nearly fell down but her husband caught her. He laid her down in bed and she could not move her arms or legs. Her speech remained slurred and gradually improved over the course of about 10 hours. The episode lasted about 10 hours and she feels fine now.
Headache, Myalgia, Arthralgia, sickest ever felt, arm swollen orange inability to raise arem Narrative:
Approx 11 hours after second injection, extreme fatigue, muscle aches, slight nausea
after second Hep B shot patient said they had pain in arm that keeps them awake at night.  Even a year later it is still bothering them.  Feels like a torn rotator cuff and pt can still feel the injection site
Rush and swelling of the arm at the injection site. Pain at the injection site. Itchy and stingy
Pt reports about 5 hours after injection developed body aches, fever, back pain, N/V, HA, chills, rash.  Went to ED and had IVF and promethazine and improved.
the day following vax pt devel hives. treated w/benadryl. rpt felt that hives were not related to therapy w/varicella
Patient described jogging 30 minutes after receiving vaccine. 25 minutes of running patient had difficulty breathing, hard to catch breath. Visual problems from bright colors to everything turning white. Nausea and shaking.
Hives on V of chest and both arms, hives would resolve every morning and return every evening for a week, chronic hives now on chest and both arms after sun exposure
About 9 hours after the Vaccination (Saturday), I had a low grade fever (101), chills, sweats, lethargy, muscle aches, significant headache. These symptoms lasted through the night.  Some symptoms lifted (fever) for 6 hours the next day (Sunday) but all other symptoms still present for a full 24 hours following onset.  Fever came back again at night (Sunday into Monday) and extreme lethargy the following day (Monday) with dizziness.
I contracted COVID-19. I had a sore throat for possibly four days. I also had a headache for maybe 3 days. I was very tired and fatigued. I slept and spent all day in bed on 06/23/2022. I received treatment of Paxlovid on the morning of 06/23/2022.
Extreme fatigue, exhaustion, and overall body pains. Sore arm at injection site.
This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of diarrhea  in a subject of unspecified age and gender who was vaccinated with ROTARIX. On an unspecified date the subject received 2nd dose of ROTARIX. At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea and vomiting. The subject did not experience these events after the first dose of ROTARIX. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were possibly related to vaccination with ROTARIX.
Angioedema tongue and throat swelling/tingling Developed tightness around neck and swelling of tongue 10 minutes after 2nd dose of COVID vaccine on 1/27/21. Epinephrine 0.3mg IM and diphenhydramine 50 mg given
PT HERE FOR PPSV23, BECAUSE SHE CARES FOR HER ELDERLY MOTHER AND IS HIGH RISK FOR CONTRACTING DISEASE. AT INJECTION SITE AND BELOW, A 5INCH X 3INCH CIRCULAR/OVAL AREA OF REDNESS, WARMTH AND EDEMA WAS PRESENT WHEN PATIENT CAME BACK INTO CLINIC. PT STATED IT WAS MUCH MORE EDEMATOUS YESTERDAY BUT SHE TOOK A BENADRYL AND SWELLING WENT DOWN SOME. PT INSTRUCTED TO USE ICE PACK OFF AND ON, AND TAKE IBUPROFEN UNTIL SYMPTOMS RESOLVE.
After vaccine was given upper (R) arm increase in soreness, and on 12/3 pt could not move her arm. It became swollen red, hot to the touch in the bicep, tricep area. Was diagnosed with cellulitis, given antibiotics x 10 days can't remember what kind of antibiotic.
I have experienced mild symptoms of rapid heartbeat, nausea, and lethargy since last night with a low-grade fever. It was 100 degrees on the thermometer last night and 99.5 degrees at noon today.
Bone pain; Pain is a 6 on scale of 1-10; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A male patient of an unspecified age (reported as 65, unit unknown) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported bone pain with of 6 on scale of 1-10. The outcome of the event was unknown.  Information on the batch number has been requested.
mom describes sudden onset vomiting 24 hrs p/MMR/HIB followed by confusion & purple spot's located on 1 side of face;
fatigue; This is a spontaneous report from a Program. This contactable year-old female consumer (patient) received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported)  as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date, the patient experienced fatigue. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected
Fever 101.6 and then I took an Advil. Muscle aches, headache. Still sick the next day but fever is down. I took another Advil for muscle aches and headache. I have had approximately 10 or more flu shots over the years and this has happened maybe three times. I anticipate I will be better tomorrow.
Fatigue-48hrs but was worse the last 24 hrs- I slept for 18 of the 24 hrs Joint Pain-48hrs Body Muscle Aches-48hrs Total Body Inflammation/Swelling- 24hrs All
Approx. 3" circular erythematous, slightly raised area that was warm to touch, slightly tender with some itching at site of DTAP.
Patient experienced dizziness about 10 minutes of getting the shot. Her Mom brought her  to pharmacist window. Patient was trying to threw up. called 911 and they came after 5 minutes and took over
I got very sick, it was terrible; didn´t sleep one minute last night; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 31st May 2022, the patient received the 2nd dose of Shingles vaccine. On 31st May 2022, less than a day after receiving Shingles vaccine, the patient experienced sickness and insomnia. On an unknown date, the outcome of the sickness and insomnia were unknown.   It was unknown if the reporter considered the sickness and insomnia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine on the day before the date of reporting. After vaccination, the patient got very sick  and did not sleep one minute at the night before the date of reporting.
Fever only on day after vaccine administration. Liquid stool and severely diminished maximal heart rate (178 -> 125) starting on day after vaccine administration and continuing for the following 6 months. Thereafter diagnosis with collagenous collitis via biopsy and autoimmune cardiomyopathy via ultrasound. Symptoms receding but ongoing.
? Chills     X's 2 days.  ? Cough ? Diarrhea
GIANT HIVE AT INJECTION SITE, LIKE A  BEE  STING SELF TREATED FOR 5 DAYS WITH TOPICAL LIDOCAINE CONTINUED FOR SEVERAL  WEEKS WITH RANDOM STINGING
On July a7the neck and shoulder pain. Later that evening really bad throat  pain .Can not lay down and can not sleep . on the 18th pulled muscled feeling in back and chest. also jaw chattering on the right . When sitting for a while felt like bones were shattering
BRUISING AT INJECTION SITE. ARM SORENESS FOR AT LEAST 2 WEEKS AFTERWARD. GENERAL DISCOMFORT IN AND AROUND THE INJECTION AREA
Aches, chills, injection site pain, flushing, couldn't get out of bed, shaking, very fearful, headache
Per pt report shingrix was administered at local pharmacy earlier this week -pt seen in office 8/29/2020 for suspected shingles rash
No adverse effects.  Child got second shot 8 days after first shot, did not wait the minimum of three weeks.  There has been no adverse effects.  Report sent as per CDC.
Pt arrived to observation area post first pfizer covid vaccination. Pt. Presented in observation with no symptoms and sat down in chair. At 2:12 pm patient raised hand for assistance. At that time patient stated that she was "dizzy." When asked if she felt going to pass out she replied, yes. Patient was placed on the floor with her head down and feet up.  Patient continued to complain of dizziness and numbness in her feet. Placed pulse ox on Patient. HR 53 O2 93, Patient continued to be alert, but was having difficulty remembering her age and previous symptoms persisted and she stated she initially felt itchiness in her mouth and throat. At 2:18 EPIPEN was given IM 0.3mg Left anterolateral thigh (Lot #0GM229 EXP 12/21). Ambulance was called. 2:20 BP 110/68 HR 78 02 95. Patient began to state her symptoms were improving still complaint of tingling in fingers and legs. Able to answer questions appropriately. She was returned to sitting in the chair. 2:23 BP 100/70 HR 85 o2 100%. Patient remained alert and oriented Heart rate and pulse remained stable. 2:30p Paramedics arrived, Patient was taken to hospital via ambulance.
Pt received her 2nd dose of the Pfizer COVID19 vaccine. While sitting in observation she proceeded to pass out. She was held up by the RN. Pt lost consciousness briefly. Pt was laid down on cot. Initial BP 91/70 JR 47, no pulse ox, Repeat BP while laying down 117/76 HR 70, pulse ox 99.  EMS was called via 911. EMS arrived and evaluated the pt.  BS  99. Pt did not want to go to the ED and a release was signed with EMS. BP 121/75 when leaving clinic. Pt reported feeling better. ED precautions were given.
chills; Nausea; Backache; fever/low grade temp of 99.5; took her temperature and measured 99.6F; stated that she has been really fairly ill/being sick; metallic taste; mild soreness in her arm; This is a spontaneous report received from a contactable Consumer(patient) via medical information team. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 27Jan2021, after 15 minutes of vaccination, the patient experienced having a metallic taste and mild soreness in her arm. On 29Jan2021, the patient ended up being sick at work, stated that she was been really fairly ill experienced chills, nausea, backache, fever. She took alternating dosages of Advil and Tylenol as prescribed by her doctor. Right now, she took her temperature and measured 99.6 F. She mentioned that she normally had low grade temperature 99.5 F in temperature. She was curious if the response was from the vaccine. The patient wanted to know if it would continue longer or may be something else. Stated that she was fine. Stated that anytime she was put under anesthesia that she gets sick. No further details provided. Does not know if what in the vaccine is similar to that. Wanted to know if she was good to go. Stated that she assumed it was a response but wanted to double check before she goes into work tomorrow. Wanted to know how long the response would last. Later clarified that it was for the Covid vaccine. Outcome of the events was unknown.
After receiving yellow fever vaccine within a few minutes pt. fainted and collapsed. While sitting on the chair she fainted and collapsed again. Paramedic came and took her BP and glucose level (71). Her guardian insisted that she go to ER to have her checked out.
c/o hardened,warm painful rt deltoid;pt stated it was the size of orange 2 days p/the shot;
This spontaneous prospective pregnancy report as received from a female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number not provided). On an unspecified date the patient became pregnant. The LMP and EDD were not known. The patient stated she was pregnant and wanted to know the symptoms of GARDASIL. Additional information is not expected.
Injection on Tuesday 10/15/2019. Patient called on 10/17/2019 reports itching, redness and swelling at injection site "described as larger than a silver dollar".  Patient also reports headache.  Advised anti-histamine & Tylenol & Cold.  Suggested report issue for records to PCP.  Suggest seek medical attention of issue worsen or lasts more than 5days.  Noted that this year received HD version which may account for the reaction.  Patient states never had had reaction to any vaccination in past nor to adhesives in past.  10/19/19 patient states has resolved.
Patient developed swelling and pain at injection site. Later in week (4 days) later patient developed palpitations and chest pain which she attributed to her injection.
got severely ill; Initial information was received on 30-Dec-2020 regarding an unsolicited valid non-serious media case from a consumer.  This case involves patient (unknown demography) who got severely ill (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got severely ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Minutes after patient got vaccine, he sat down, started visibly sweating, threw up, reported being dizzy, light headed.  Reported "blacking out"
PT recieved Anthrax vaccine without notifing Immunization techs about being 5 weeks pregnant.
Pt developed a bacterial infection shortly after vax, She was treated with several courses of antibiotics and the infection resolved. She also experienced redness and swelling of her hands that extended over her body. This resolved. However, when she is exposed to heat, her skin swells and becomes red, hot and itchy. When she is exposed to cold, she feels a numbing effect. She experienced slight muscle pain and periodic slight fever both of which continued as of which continued as of 02/07/2000. Raynaud's phenomenon was reportedly ruled out. Thyroid function tests and all hematology tests were reportedly normal. A skin biopsy was reportedly non-diagnostic. Additional information from the physician indicated that the events reported following receipt of Pnu-Imune 23 can not be medically confirmed.
10:12 - BLOOD PRESSURE 120/84, PULSE 62, OXYGEN SATURATION 98, RESPIRATIONS 18. PATIENT IS COMPLAINING OF FEELIN WARMER AND FLUSHED IN FACE AND FUNNY FEELING IN CHEST. PATIENT SAYS SHE HAS NEVER FELT THIS FEELING BEFORE. PATIENT DENIES SHORTNESS OF BREATH OR CHEST PAIN, SKIN WARM AND PINK. 10:23 - PATIENT STATES FEELING REMAINS UNCHANGED. PATIENT REQUEST SOME WATER, WHICH  WAS PROVIDED, AND PATIENT TOLERATED WELL 10:29 -  OXYGEN SATURATION 98, PULSE 67. PATIENT STATES FEELINGS DECREASING 10:38 -  PATIENT STATES NO FAST  HEART RATE, SHE DRANK WATER AND TOLERATED WELL. COLOR GOOD, DENIES CHESTPAIN. PATIENT STATES SHE FEELS NORMAL 10:45 - OXYGEN SATURATION 97, PULSE 65. PATIENT DROVE SELF HOME
A medical assistant reported that a 2 month old infant received Acel-Immune, Hib-Titer and IPV vaccines on 01/09/2001. On 01/12/2001, the infant developed spells of unresponsiveness and staring into space.
Was taking a bottle, starting choking and started with seizure activity, parents called EMS. In ER Fever and seizure activity. CBC with diff, chem 14, UA with culture, head CT w/o contrast, chest x-ray done in ER. Seen Dr on 09/10/15 at 14:33 pm, for mild ataxia, rechecked PLT count.