chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a patient who on 18-FEB-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot # reported as 1538U). On 18-FEB-2008, the patient developed a "welt" at the injection site. As of the time of this report, the patient's welt at injection site persisted. No additional information was provided. Additional information has been requested.
Pt complains of redness and itching at site, nausea, and fever. Pt did not check how high the fever got. Reports feeling terrible.
extreme swelling after less than 48 hrs of vaccination on right thigh. No fever, no pain, only red on the thigh 4th.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 06-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N034554, expiration date 05-DEC-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
DON phoned patient's mother on 6/12/18 to notify her that patient had received an expired dose of Tdap (BOOSTRIX, Lot#393D9, Exp 5/28/18). Mother reported she was just returning home with patient from Hospital following patient being hospitalized for a seizure. Patient received vaccinations on 6/1/18. Mom reports patient complained of his arms being sore, runny nose and generalized malaise on Sunday, 6/3/18. On Friday, 6/8/18 at 12:46pm patient had a seizure. Mom reports patient was awake and responsive following the seizure. He took TYLENOL for a headache following the seizure and fell asleep. Family was later unable to awaken him and called 911. Patient was taken to Medical Center by EMS and then transferred by ground unit to another Hospital where he was admitted to ICU. Patient remained unresponsive and in ICU from Friday evening, June 8th through Sunday morning, June 10th. Patient was transferred to a regular floor on Sunday evening, June 10th and discharged to home on Tuesday, June 12th. Mom reports he is feeling better each day. Mom reports patient has a follow up appointment schedule with Neurology Clinic on Thursday, June 28th. She reports they have been advised to not receive any further doses of HPV vaccination.
pt recv vax & lying on back on floor w/eyes open;appeared pale, mildly diaphoretic;pt lightheaded; BP 98/58, P52;BP 104/70;
Missing  2 periods/menstrual cycles in December and January. Prior to this no missed periods in over 10 years.   First Pfizer shot was taken 8/24/2021 and second on 9/1/2021.
Rt deltoid red/swollen 9 x 7cm Tx: Tylenol/Benadryl/ cool compress.
1/11-Received vaccine @ 11:55am and by 9pm my right shoulder started to hurt-centralized to the joint area. 1/12- Right shoulder pain continued to increase. Couldn't sleep or perform normal daily functions by next morning. 1/13-Shoulder pain continued to get worse and lost more range of motion.  Went to the Emergency Room @ 3:30am and was there until 11:30am the next day.  Ran a number of tests below. 1/14-pain had subsided a little bit  due to prescriptions from Dr. at hospital. (Robaxin, Prednisone, Ibuprofan and Tylenol). 1/15- 9am Dr. appointment with primary care physician via telehealth.  Received referral for a Dr. who specializes in Ultrasound Scans. 1/16-1/18(today) Pain had continued in right shoulder, centralized to joint area with no other symptoms.  Went to physical therapy this morning @ 9:30am to do range of motion tests.
prolonged crying 12-16 hrs w/erythema/tenderness @ inject site lt thigh);
Error: unauthorized age group (17-year-old, Moderna EUA approved only for persons 18 years and older. Patient signed consent form with incorrect DOB indicating age greater than 18 years). Event discovered and forwarded for reporting. Signs and symptoms: None known. Diagnosis and treatment: None known. Outcome: No adverse reaction reported.
Patient felt light headed and weak, EMS called, patient recovered within 5 minutes. Will keep in observation for 20 more minutes.
Anthrax lot #FAV110 administered after expired date due to administrative oversight.  No adverse reaction at this time.  Report submitted per milvax direction.
patient reported an immediate onset of symptoms beginning approximately 30 minutes after vaccination. Symptoms included nausea, light headedness, dizziness and headache. Patient was seen by pcp and prescribed zofran and instructed to rest and drink plenty of fluids.
ABOUT 8 HOURS AFTER VACCINE THE PATIENT STARTED EXPERIENCING EXTREME PAIN IN LEFT ARM FROM PNEUMOVAX 23 AND COULD NOT MOVE HER ARM.   THE PATIENT HAD A LOW  GRADE FEVER THE NEXT DAY ON 8/29/19 AND EXTREME LEFT ARM PAIN.  ON 08/30/19, THE FEVER STOPPED, BUT  THE LEFT ARM IS IN EXTREME PAIN, AND IS EXTREMELY SWOLLEN FROM SHOULDER TO ELBOW AND HAS A RASH FROM SHOULDER TO ELBOW.
When the Pfizer vaccine was given 3/23/21 it was assumed it was his first dose since individual answered he had not received any other vaccines in the last 14 days, however, it was later discovered in state data base as first dose Moderna given 3/5/2021 at a clinic. Caregiver who brought him to the appointment was also unaware he had received his first shot at a doctor's appointment.
dose number 3; sore arm; light headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 12Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 immunization, reaction(s): "Headache", "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "dose number 3"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 12Oct2021, outcome "unknown", described as "light headache". It was unknown if therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. It was unknown, if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient diagnosed with COVID-19, prior to vaccination. It was unknown if patient been tested for COVID-19, Since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
joint pain; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 02Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced joint pain on an unspecified date. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
red swollen area on her arm; red swollen area on her arm; red swollen area on her arm; red swollen area on her arm/injection site reaction; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 73 years old female patient who experienced red swollen area on her arm (erythema)( swelling) and injection site reaction (vaccination site reaction) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious red swollen area on her arm (inflammation)  (erythema) (swelling) (Unknown latency) injection site reaction (vaccination site reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was red swollen area on her arm.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for red swollen area on her arm, as Unknown for red swollen area on her arm, as Unknown for red swollen area on her arm and as Unknown for injection site reaction.  Information on batch number was requested.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. No information on treatment medications was reported.
This spontaneous report as received from a physician refers to his son, a 11 year old male patient. There was no pertinent medical history, and no known drug reactions/allergies. On 04-OCT-2012 the patient was vaccinated with the first and only dose of GARDASIL 1 DF, intramuscular (dose strength not provided). There were no concomitant medications. On 04-OCT-2012 the patient experienced injection site pain after receiving the vaccination. The patient was treated with TYLENOL. No medical attention was sought. The outcome of injection site pain was reproted as recovered/resolved on approximately 08-OCT-2012 (4 days after vaccination). Additional information has been requested.
his arm is little swollen; His arm is hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (his arm is little swollen) and VACCINATION SITE WARMTH (His arm is hot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (his arm is little swollen) and VACCINATION SITE WARMTH (His arm is hot). At the time of the report, VACCINATION SITE SWELLING (his arm is little swollen) and VACCINATION SITE WARMTH (His arm is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided no treatment taken
Hospitalized (1.24.22 - PRESENT; in ICU);  COVID-19 positive (1.18.22);  Fully vaccinated (no booster) 1.24.22 - Intubated in ED of outside hospital - HPI: 44 y.o. with Down Syndrome, per father fairly high functioning.  She has a history of OSA not treated (noct O2), and respiratory failure in the past that led to prolonged trach and eventual decannulation in 2012.  She was COVID-19 positive on 1/18 and presented to the ed with worsening hypoxemia, and was intubated in the ed.  A 6.5 ETT was placed due to her prior tracheal stenosis.  She was given 2 L of ivf in the ED, and CT angio showed no PE but did show small bilateral effusions and extensive bilateral airspace disease, more posterior. She was transferred to hospital for continued care. Labs were also notable for AKI.   ASSESSMENT / PLAN:  44 y.o. female with Down Syndrome, remote resp failure/trach with history of tracheal stenosis, untreated OSA, admitted on 1/24/2022 with acute respiratory failure with hypoxemia.     Assessment and Plan Acute respiratory failure with hypoxemia  Assessment & Plan Due to covid-19 Intubation date: 1/24/22 Current respiratory support: Device (Oxygen Therapy): ventilator Vent Settings:   Lung mechanics: Plateau Pressure: 34 cmH2O Peak Pressure: 39 cmH2O Patient-ventilator interaction: o synchrony ? Neuromuscular blockade: Yes  ? Proning:Yes  ? Body Position: prone, head left facing Sedation: o RASS goal: -5 o propofol o fentanyl VAP prophylaxis: Chlorhexidine  GI prophylaxis: PPI DVT prophylaxis: subcutaneous heparin Plan: Goal TV 4-6 ml/kg with pPlat <30, ph 7.24 - 7.4 Goal SpO2 88-92%, PaO2 55-65  Initiate proning PEEP 16   * COVID-19 Assessment & Plan Vaccinated x 2, not boosted Positive test: 1/18 Severe respiratory isolation until 2/8/22 and fever-free   Secondary infection workup: MRSA swab pending Sputum culture pending   Treatment: Remdesivir: none due to AKI Tocilizumab: none due to shortage   Steroids: Methylprednisolone 40 mg iv q8h 1/24 - (1mg/kg)   Antibiotics: Ampicillin-sulbactam 1/24 -    Shock  Assessment & Plan Hypotensive Suspect largely due to sedation, possible pulmonary hypertension Check echo Empiric antibiotics (ampicillin-sulbactam) Follow up cultures   AKI (acute kidney injury)  Assessment & Plan UA Foley Follow I/O  Progress Note from 2.1.22:   Plan:  Intubated and sedated in the ICU  N: Continue RASS-5 while paralyzed and proned.  CV:  Contd. Diuresis Pulm: Stop prone, keep paralyzed, optimize PEEP GI: Continue goal feeds, having stool Renal: Lasix to keep even to net negative Heme: NAI, baseline anemia, on prophy lovenox due to BMI ID: On unasyn, last day today for 7 day course Endo: Continue current basal bolus schedule, reduce Lantus PLAN 2/1/2022 - Optimize PEEP back to 16 - Keep Pplat < 30 and DP < 15 - Monitor ABG - Control alkalemia as able - Continue on deep sedation and paralytics - Wean steroids by 10mg q5 day given relative improvement - Completed course of abx for MSSA - Sedation related hypotension, low requirement of norepi, stable - Continue diuresis with Lasix 20mg daily to keep even to net negative - Tube feeds are at goal - Bowel regimen acceptable - BS acceptable on BBI - GI / VTE ppx
Rash, peri vaccine and on extremities, itchy blanching papules, flesh colored papules on hands
Patient describes soreness in shoulder down into elbow with some some slight tingling in forearm/hand later that day.  the soreness did worsen at night and had trouble sleeping.  The pain didn't worsen but has not lessened either.  after a few days she went to her primary care physician who thought it may be a site injection issue and referred her to an orthopedic doctor to rule out a nerve issue.  She contacted us the following Wednesday (1 week) after the vaccine administration to let us know of the issue.  I reached her on Thursday  to get the information to complete this report.  She was to see the orthopedic doctor on 10/30/2020
Within 15 minutes post second vaccine, patient developed itching of mouth, arms, and "full body" per EMS. Paramedic administered 50 mg Benadryl IM. Patient accepted transport to hospital via EMS for additional assessment and monitoring.
a lot of weird heart throbbings; don't feel good; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (a lot of weird heart throbbings) and FEELING ABNORMAL (don't feel good) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05DE21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (a lot of weird heart throbbings) and FEELING ABNORMAL (don't feel good). At the time of the report, PALPITATIONS (a lot of weird heart throbbings) and FEELING ABNORMAL (don't feel good) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications details were not reported by the reporter.  Reportedly, Patient wanted to know the detailed ingredient list of exactly what was in the vaccine. Patient had been suffering from this symptoms for a year and three months.  Treatment details were not reported by the reporter.
3 hours after vaccine, my arm started hurting. That night I vomited, and I ran a fever the next day as well as chills, achiness, and that went on, but the fever and nausea went away and the achiness and general malaise lasted a week. Then, it took another two weeks for me to gain strength. I was laid out and had no energy. It took 2-3 weeks to go away. The shaking started; the appetite loss started about the same time as the shaking. I still have no appetite, but the shaking has stopped. The last time I was admitted into the hospital my blood pressure was 220/95 so they are trying different medications to see what will bring it down. I am still having blood pressure problems, and this morning it was 198/79 before I took my medication. I usually wake up and it's high and through the day it starts to drop. I have been seeing a cardiologist because they were afraid with my blood pressure so high, I would have a stroke or a heart attack. On Oct 19 I'm having a stress test. And on October 25th I'm having ultrasound of legs.
Pt noted lump under left axilla 3 days post vax. He noted tingling and numb feeling anterior arm. Stiffness left lateral neck and into shoulder. These were with no known trauma. Pt sent to have neurologic evaluation. This found borderline weakness of most of the muscle groups on the left upper extremity, decreased sensory to pinprick temperature. Deep tendon reflexes at triceps, biceps & brachial radalis were decreased.
In January of last year 2021, I started to notice a couple of spots on my leg and the back of my head. I emailed my doctor and told him about the spots and sent him pictures. My doctor stated that it was plaque psoriasis. He advised me to use some hydrocortisone on the spots. Also, when I wake up in the morning my hands are very numb. I have not had any in person visits.
Pt did not wait 15 min observation period. 5 minutes into driving home her throat started closing up. She was still able to breathe and drive him. She said after 30 minutes. Was resolved
Moderately severe burning type paresthesias in feet and hands. Painful tingling lasted 45-60 minutes then would resolve spontaneously. The painful symptoms would recur 3-8 times per day and are ongoing at the time of this report. Medical attention has not been sought due to symptoms resolving for hours at a time. Will likely contact neurologist next week if symptoms persist.
On the evening of the 4th, my body was in pain. It started on my left side and continued to the left side. I had a pain in my head that was so severe, even my teeth were hurting. It hurt for anything to touch me. I saw my doctor and she explained there was some adverse effects from the vaccine. It seemed it triggered my Fibromyalgia like it has never been treated. She gave me 60gram of Toradol and Meloxicam. The Toradol knocked me out completely, from 05/05/2022, I have been sleeping. I awoke today 5/6/2022 with a headache and achiness in my body. I  have had a negative COVID-19 test twice. Basically my doctor called today and I told her that I was doing a bit better. I don't want anyone else to go through the pain I went through, I was in such severe pain I was asking God to take me. I also had dizziness if I stood up to long.
Information has been received from a consumer concerning her 4 year old son with no pertinent medical history, no drug reactions/allergies, who in 2007, was vaccinated with a first dose of MERUVAX II. On 27-FEB-2009, the patient was vaccinated with a second dose of MERUVAX II. There was no concomitant medication. "4 hours after receiving the MERUVAX II, the patient experienced vomiting for 4 to 5 times. The patient had been seen getting tired easily lately. The reporter called the physician office. On an unspecified date, the patient recovered. Additional information has been requested.