chrisvoncsefalvay/vaers-outcomes huggingface dataset:
July 29 got shingles vaccine. On 8-30-09 Developed marked pain right breast . Three days  later developed brilliant red blotches. Two days after that developed erythema of left breast pain resolved. Now had fever 99.5 no pain. N itching but erythema persists. Gets redder in evening.
Pt put to bed 930PM 15MAY91 well; Awakened during night & had t101; Given non ASA med to dec fever; Pt went back to sleep had to be awakened @ 745AM; Cont to sleep on & off thru morning;
Information has been received from a physician concerning a ten month old female with no pertinent medical history, drug reactions or allergies who on 15 APR 2008 was vaccinated orally with 2 ml, a second dose, of ROTATEQ ( Lot # 659914/1732U).  Concomitant therapy included DTaP-IPV-HIB (OMPC) (manufacturer unknown), pneumococcal vaccine (unspecified) and PEDIARIX.  On 15-APR-2008 the patient developed diarrhea two hours after receiving a second dose of ROTATEQ.  Medical attention was not sought.  It was noted that the patient received a first dose of ROTATEQ on 15-AUG-2007, at eight weeks of age.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
I just had the sore arm at the injection site. Tested positive for COVID on January 12. Started feeling about five days prior to be testing for COVID, felt bad another three days after testing positive.
Mom states baby was Seen by MD for sz type s/s on 5APR91;
Rebound COVID; Rebound COVID; pregnant last menstrual date 17Feb2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 17Feb2022. The patient is expected to deliver a baby(s) on 23Nov2022. Concomitant medication(s) included: PROZAC. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 2021, outcome "unknown", described as "pregnant last menstrual date 17Feb2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Rebound COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information:Patient received treatment for Covid-19 with Anti viral from 08Jun2022.to 13Jun2022. Patient received Prozac in 2weeks. Device timestamp: 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route of administration were unspecified) lot # N002913 (expiration date 23-FEB-2019) for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature excursion of 32 to 35 Fahrenheit degrees for a timeframe of 72 hours. There was no previous temperature excursion or digital data logger involved. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA006453.
pt recv vax 1JAN98 & 10JAN98 pt exp fever of 103;
Systemic: Cardiac Disorder (diagnosed by MD)-Medium; symptoms lasted 1 day
At 11:35 am caregiver stated feeling pulsating sensation and pain in her mid back. No other symptoms reported. Vital signs were taken with in normal limits. BP:119/76, HR: 84, Sp02: 96%  denies allergic reaction. Caregiver was observed for an hour in caregiver health office. Per caregiver she requested to leave.
Around 7:00 pm same day of shot I experienced headache, body aches, fever, heavy feeling in my chest.  The heavy feeling in my chest subsided after a couple hours, while the fever, body aches and headache continued for approximately 24 hours.  When those symptoms subsided, I continued to experience light-headedness and fatigue.  The temperature ranged from 100.5 to 101.5 for 2 nights.  On Day 3 I experienced diarrhea.  Today is Day 5 after the shot and I still have bouts of light-headedness,  but overall, much better.
viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received 2nd booster dosage.  Patient received dose from the same vial lot and number of doses/vials were 6 doses from the same vial. Vial was initially stored in the refrigerator on 16-Jun-2022 and vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow-up has Significant information in which case report type was turned from invalid to valid. Patient detail, suspect product name, new event, Vaccine information (Dose Description) and Supplement were updated.
Extreme pressure in stomach/abdomen. Hard/labored breathing. Diarrhea and nausea and vomiting. Panic and anxiety.
By 08/30/01, the patient became very cranky and irritable, temp > 103 - 104, lasted for 48 hours.
Shortness of Breath; allergy; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID.  A 72-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious) with onset 24Feb2022, outcome "unknown", described as "Shortness of Breath"; HYPERSENSITIVITY (non-serious) with onset 24Feb2022, outcome "unknown", described as "allergy".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Mild, Additional Details: Following patients first dose of Pfizer, she reported a it swelled up like a "large marble". She reported redness that went all the way down her arm and it took about 1 week for pain and redness to improve. There still is a hard node under her skin at the site where vaccine was administered. Patient came in for second dose and reported these symptoms from 6/22. Instructed patient to follow up with PCP and to monitor.
breaking out into hives; still has a little knot on the outside of the left arm where she received the injection; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out into hives), VACCINATION SITE MASS (still has a little knot on the outside of the left arm where she received the injection) and PYREXIA (fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (breaking out into hives), VACCINATION SITE MASS (still has a little knot on the outside of the left arm where she received the injection) and PYREXIA (fever). At the time of the report, URTICARIA (breaking out into hives), VACCINATION SITE MASS (still has a little knot on the outside of the left arm where she received the injection) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
erythema with swelling to right upper thigh, bruising noticed at office on 03/08/2010, not warm to touch approx 6cm in dia
The patient was administered an improperly stored dose of  PEDVAXHIB; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-OCT-2019, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S000356, expiration date: 17-OCT-2021 (dose and route of administration were not provided) for prophylaxis. No adverse effects were reported.  Administered dose of vaccine experienced temperature excursion of 46.5 degree Fahrenheit for 15 minutes. No previous temperature excursion was reported. Digital data logger was not involved.
Pt is a 42 y/o female here for numbness in bilateral arms about 1.5-2 hours ago.
Permanent loss of smell, acute anxiety, repeated panic attacks Acute memory loss, temporary amnesia Dizziness, acute to prevent walking Brain fog, fatigue
rapid heart rate; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 10th December 2019, 1 days after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was unknown.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient was received Shingrix vaccine and experienced rapid heart rate.
Approx. one minute after injection, pt. went limp, slid to floor from a sitting position, loss consciousness for a few seconds, brief tremors noted, pt awakened with small swollen area on left forehead. Pt ambulatory afterwards.
Developed a rash on my left arm near the injection site. Rash was itchy and mildly painful. I talked to my sister who is a physician and she told me to take a picture of the rash and to draw a circle around the rash to track if it was changing. I did that and the rash faded by the next day
Right hip had severe pain & fluid buildup particularly where I had injured my upper thigh in a fall by the waterfront last May.  Was unable to walk without a walker.  Also high fever.  Saw Dr and had X-ray and MRI  - no surgically repairable hip damage just signal changes (fluids) in Gluteus Maximus and Medus and IT Bands probably location of injury from fall the previous May.  Had CBC blood panel   White count was normal but C-Reactive Protein (CRP) was very high indicating an inflammatory reaction to the vaccine.  Everything points to interaction with the vaccine. Dr referred me to.
By 11/28 evening upper left arm was red, swollen, itchy. Following day, more swelling, hot to touch, very itchy. 4 a.m. 12/14, severe swelling in knees, wrists, entire left arm huge and hot, hives over whole body, fever, itchy pain. ER, vomiting, dropping blood pressure, swelling and rash whole body. Dx serum sickness. Symptoms lasted 3-4 weeks. 2 days in hospital. Wheezing, swollen lips, trouble walking. A lot of joint pain.  3/20/09 Received PCP medical records of 12/3/08-3/2/2009. FINAL DX: serum sickness, amoxicillin vs vaccines Records reveal patient w/persistent cough & postnasal drip x 3-4 wks when seen 12/3 w/poor sleep secondary to cough.  Initially had URI w/croup, phlegm now dx w/sinusitis & tx w/oral antibiotics.  Exam on 12/12 was well child, had been seen in OT but stopped some time prior, being watched for social lag.  RTC 12/16 s/p hospital admit visit for swelling of lips, knees & wrists.  Tx w/nebs & antihistamines.  Now had tongue tickling, sleepiness, urticarial rash all over, left arm very swollen, purplish, hot, swollen joints.  Followup w/allergist.  Allergy consult 1/9/09. FINAL DX: serum sickness like reaction likely penicillin allergy Suggested patient have FluMist in future.  Continued to have wheezing & tx w/nebs.  Abdominal distension/discomfort was likely due to constipation.  Had trace proteinuria in hospital & UA repeated but not included.  Was to return in 2 wks.  4/10/09 Received hospital medical records of 12/14-12/15/2008. FINAL DX: serum sickness Records reveal patient experineced pruritic erythematous maculopapular lesions and red swollen left arm, bilateral knee pain w/swelling x 2 days.  Tx w/antihistamines, NSAIDs & nebs.  Had orthostatic hypotension w/dizziness & nausea/vomiting in ER & tx w/IVF w/improvement.  D/C to home w/PCP f/u.  Clinic visit 12/29/2008 s/p hospitalization.   FINAL DX: serum sickness like reaction, suspect amoxicillin reaction Doing well w/rare use of NSAID for joint pain, daily zyrtec & intermittent albuterol for coughing.  Meds were discontinued due to improvement & was to continue albuterol as needed.  Felt to be constipated due to recent illness.  UA was to be repeated.
Missed appointment for second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed appointment for second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed appointment for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed appointment for second dose) outcome was unknown.
Caregiver called on 10/8/2021 stating the vaccine site progressed to now what is a limited range of motion of the shoulder and upper arm;  Her upper arm is very painful;  She states she has never had this type of reaction in the past;  She denies infection, numbness, tingling to the forearm, hand and fingers;  She denies that this is an allergic reaction but did take Benadryl with no change in symptoms;  She has taken Motrin for her pain with little improvement;  She was offered an appointment with a physician  but declined, however, she will be following up with her PCP;  She informed her supervisor who recommended she contact our department;
Lot for the second dose is 020F21A  May 27, 2022 calf started cramping and foot fell asleep with sever pain in right leg while playing golf in the afternoon.  That evening the right leg was much colder to the touch with  prolonged capillary refill of hallux.  After speaking with his doctor on the morning of the May 28th, the subject went to the emergency room where an ultra sound was preformed with inconclusive results.  He was sent to a Vascular specialist.  On June 14th an angiogram was preformed showing a complete blockage of the femoral artery.  On June 23rd a surgical thrombectomy
woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Top of (R) leg at injection site swollen and red - approx. size of a "saucer". Advised oral and/or topical BENADRYL, Ibuprofen and ice packs.
48 hours of rigors and headache followed by lack of appetite as well as neuropathic pain over the thorax. No treatment except over the counter medications for symptoms.  All symptoms except lack of appetite have resolved.
Patient got a first dose of Covid vaccine . After about 5 minutes of sitting and waiting on the mandatory 15-minute wait, she complained having  aa swelling sensation inside the throat. She did not have difficulty breathing nor was she gasping. Patient was placed under close observation, and after about 5 minutes she complained that the condition was getting worse, still was breathing normally. At this point, however, EpiPen (0.3mg) was administered intramuscularly.. After about 2 minutes following the injection , she got better and improved a lot. She was still observed for further 15 minutes after which she was discharged. She was advised to follow up with her physician and to seek medical assistance if the condition repeats.
Mother reports that she noticed the swelling Thursday night that starts at the L shoulder and extends to the L elbow with redness and it. warm to touch. Child with 98 deg F temp orally and without any complaints of discomfort. Referred to MD, child's pediatrician.
Intense fever and chills the night of vaccination. On going fever since that that 8/13. Fever everyday since the date of vaccination as well as intense fatigue, muscle weakness, lack of appetite, sleepiness, pain in back and other muscle aches, chills and cold. It is now 8/24 and I feel worst.
I had the vaccine on 01/14/2021 and a couple of weeks later my hands and legs started to get swollen. My doctor sent me to get some x-rays for my hand and it came back with no arthritis and also an ultrasound for my leg because it hurt and I had an edema and this was to rule out any blood clots. There were no blood clots. A couple of weeks before this I hit my leg with a dishwasher door and it was healed, later my ankle area was sore and swollen. They also did blood work and it came back normal. They just told me to take Ibuprofen 800 for inflammation.
Patient was given a 2nd dose of Hep B on 05/01/20, no treatment necessary, patient showed no adverse reaction.
Passed out, fever, chills, dehydrated, dizzy, still cant walk straight and without almost passing out. Being sent to see another Dr in a few days.
She called in to the pharmacy yesterday and spoke to one of the girls reporting of pain around the injection site and also that it was red, swollen and hard. She didn't remember who she talked to, but she said they told her that was normal and not to worry about it. She woke up this morning and it was worse. She also had a fever and said it was hot around the injection site.
EXPIRED VACCINE ADMINISTERED (DOSE ADMINISTERED WHICH WAS DRAWN UP IN A PRE-FILLED SYRINGE AND STORED AT 65-70 DEGREES FAHRENHEIT FOR 3 HOURS PRIOR TO ADMINISTRATION); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was not known whether the patient had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, the patient experienced expired vaccine administered (dose administered which was drawn up in a pre-filled syringe and stored at 65-70 degrees fahrenheit for 3 hours prior to administration). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (dose administered which was drawn up in a pre-filled syringe and stored at 65-70 degrees fahrenheit for 3 hours prior to administration) was not reported. This report was non-serious.
patient is 83 years old male with past medical history of hypertension, diabetes mellitus and dysphagia brought into the emergency room from nursing home with episode of shortness of breath and slow heart rate. Patient is status post tracheostomy and PEG insertion, patient is unable to give any history because he is nonverbal
Moderna COVID-19 Vaccine EUA Developed a large rash that would often itch in several places on upper arm where the vaccine shot was given. It first appeared more than a week after the first round of the vaccine.
3 hrs p/vax pt started vomiting & had temp of 104 for @ least 24 hrs; pt given @ least 2 doses of PAPA; (mom cannot remember total doses) did not call pvt MD:
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: After patient received vaccination she felt slightly dizzy and nauseous. Monitored pts bp and she was in the normal range. She sat for about 15 min and she felt better. She left after she came back to normal. Followed up with the patient 3 hours later and she is okay.