chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  2112USA003883: 2112USA003885: 2112USA003882: 2112USA003881: 2112USA003884:
Pt had history of feeling light headed with flu vaccine. We planned to monitor for 30 minutes post COVID vaccination. About 15 minutes after vaccination pt stated she was feeling dizzy and having some chest pressure.  Took BP (140/100) and sat with pt for about 5 minutes. Pt then stated that her chest pressure was feeling worse and she was feeling like she was going to pass out. We are a pharmacy but located inside of a hospital. We paged up to the emergency department to send someone to take her to the emergency room. Emergency staff arrived at about 1:25pm to take pt up to ER. I gave history and vaccination details to nursing staff
Patient came to get COVID-19 MODERNA booster on 12/8/21.  Patient then called us 3 days later to say that the vaccination was given too high up in the shoulder area instead of in the muscle area.  Therefore, she said she had to see an MD and was having limited mobility and pain.
Rash all over chest, torso, neck, face From 1:00 pm on 1-15-21 and woke up at 8:00 am on 1-16-21 and rash was gone.  Took tylenol and benedryl before bed on 1-15-21
Approx. 3 days after receiving the vac. my mouth and bottom of my left foot began to hurt/sore. This continue, so we contacted the office the vac. was administered and they set me up to visit one of their doctors.
3 days after - felt bad, night had fever 101 - called Doc on call - Took TYLENOL. Broke out in mild shingles rash - Took Valacyclovir oral and cream. Rash gone in 2-3 days.
Hives on chest, arms and stomach, paleness, weakness, itching mouth, throat and lips, clammy, hot/cold chills.
This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017, 26-JUL-2017 and 05-SEP-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003158: US-009507513-1709USA012767:
This vaccination expired on 8-1-21, and was administered on 8-4-21. No adverse events during the 15 minute stay period.
Patient received her flu vaccine on 9/30/2019.   Woke this morning with a red bumpy rash , itching on her Lt upper Thigh.  Patient reports no changes in her health, denies any food allergies or changes in any home products.
Left upper arm with 8.5cm circular, raised tender red, swollen lesion at site of vaccine injection 40 hrs after injections. Very pruritic. No fever or chills, no enlarged axillary nodes.
Shortness of breath, chest pain, dyspnea, Pulmonary HTN, Left Bundle Branch Block, Edema, Fluid Retention.
AFTER PATIENT RECEIVED THE VACCINATION, HE SAT DOWN IN THE WAITING AREA.  AFTER APPROXIMATELY 1 MINUTE THERE WAS A NOISE AND I NOTICED THAT HE WAS SLUMPED TO THE RIGHT SIDE AND STARTED TO CONVULSE.  I RAN OUT TO THE PATIENT AND ENSURED THAT HE DID NOT FALL AND HELD HIM IN PLACE UNTIL HE STARTED TO COME TO.  AFTER ABOUT 30 SECONDS THE PATIENT STARTED TO BECOME AWARE AND COULD HEAR ME TALKING BUT WAS STATING HE COULD NOT SEE.  AFTER ABOUT 30 SECONDS HIS SIGHT RETURNED.  DURING THE TIME THAT I WAS FIRST WITH THE PATIENT, THE STORE MANAGER CALLED 911 AND THE EMS WAS ON SITE AFTER APPROXIMATELY 5 MINUTES.  I HAD THE CUSTOMER SIT DOWN AND GAVE HIM WATER UNTIL THE PARAMEDIC ARRIVED.  THEY TOOK A HISTORY OF THE PATIENT AND AFTER A FEW MINUTES TOOK HIM BY AMBULANCE TO THE LOCAL HOSPITAL FOR ADDITIONAL OBSERVATION.
tinnitus,  Have had tinnitus for decades, but after first shot, more pronounced.  Mentioned to primary md some few months later.  Since having it in the past, (never this constant or loud) have bee living with it.
Staff RN administered an additional HIB to a patient during a clinic visit. Patient did not receive the Hep B as ordered by the provider.
8 years old recieved Flublock yesterday, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA282006 and 2019SA281961 (same reporter).  This case involves an eight years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date (reported as yesterday).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Flu vaccine received 12/5/14 in early afternoon at about 2:00 pm. By Sunday morning upon awakening (R) upper arm, site of inj was itchy, swollen, red, put ice pack on with some relief. By date of report has had improvement. Redness minimal, swelling decreased, tenderness not present, no more itch.
elevated liver enzymes/ALT 42; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (batch/lot number: FD7218), in right arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Exparel, reaction: "known allergies possibly". Vaccination history included: Bnt162b2 (dose 2, batch/lot EL9269, vaccine location right arm), for COVID-19 immunization, reaction: "broken ankle", "has been quite doozy", "headaches", "highly elevated liver enzymes", "nausea", "high fever", "vomiting"; Bnt162b2 (dose 1, batch/lot EL9262, vaccine location right arm), for COVID-19 immunization, reaction: "felt little poorly for 24 hours", "slight fever". The following information was reported: HEPATIC ENZYME INCREASED (hospitalization), outcome "recovering", described as "elevated liver enzymes/ALT 42". The patient was hospitalized for hepatic enzyme increased (hospitalization duration: 4 day). The event "elevated liver enzymes/alt 42" required emergency room visit. The patient underwent the following laboratory tests and procedures: ALT: 42; liver enzymes: elevated. Clinical course: The reporter informed that facility type vaccine was at doctor's office/urgent care. The patient had no covid prior vaccination. The reporter informed that the patient experienced elevated liver enzymes after each Covid vaccine and after 3 dose, ALT was 42. The reporter informed that the AE resulted in emergency room/department or urgent care and treatment was 4-day hospital stay. The patient was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300090366 same patient/product, different dose/events;
Chills/fever up to 102.2 F overnight, one episode of nausea/emesis, fever of 101.5 F the following evening
Cried 31/2 hours ran fever for 5 days never over 101.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
On 6/22/2022, I had a sore throat, nasal congestion, headache, and dry cough. I took a home antigen test and got a positive result, and I called my doctor to see about getting Paxlovid. I got a prescription for Paxlovid, which I began taking on 6/23/2022. The doctor also prescribed me vitamin D. The medication gave me a terrible, bitter taste in my mouth, but I started feeling better within a day or two of taking it. I also never had a fever. I tested negative within about six days of testing positive and felt much better. I felt fine afterwards, as I had no lingering symptoms, and the aftertaste went away when I finished the medication. On 5/8/2023, I had sore throat, slight headache, and a low-grade fever. I took a home antigen test and got a positive result. On 5/9/2023, I contacted my doctor when the symptoms worsened, and I was again prescribed Paxlovid, which I began taking that day. I again experienced the bitter aftertaste with the medicine. I again also had the symptoms of nasal congestion, sore throat, dry cough, headache, as well as a fever. My low-grade fever lasted for about a day or two. I also experienced fatigue that I didn't experience the first time I had COVID-19; I slept a lot for a couple of days. Again, I tested negative within six days of testing positive. The fatigue lingered for about ten days after I tested negative. It wasn't as bad as it was during the two days I slept, but it was noticeable. It gradually got better every day afterwards, and I pretty much felt back to normal on 5/27/2023.
After apx. 5 min after receiving 2nd HPV vaccine pt passed out. Pt rested lying down - cool compress to head. BP immed after passing out 98/54 BP 15 min after resting 106/64.
This medically confirmed spontaneous report (initial receipt 27-Sep-2013) concerns a female patient. On an unknown date, the patient received influenza vaccine (batch and manufacturer unspecified). The patient got shortness of breath from the flu vaccine and experienced short term arm paralysis after administration of PNEUMOVAX 23. Flu vaccine and PNEUMOVAX 23 were administered at another site. The reporter had no information about the administration of the flu vaccine or the PNEUMOVAX 23, including when they were administered or if they were administered together or separately. The event outcome was recovered.
Information has been received from a consumer concerning her daughter a 5 year old female (also reported as a 2 year old) who was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently the patient developed autism, which the mother attributes to her vaccinations, all of them, not to any one vaccine in particular. It was noted that she was through a battery of test which confirmed an alarming amount of mercury in her system. Upon internal review, the patients autism was considered to be an other important medical event (OMIC). It was reported that the patients sister WAES0603USA01672 also developed autism after vaccination with measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Additional information has been requested.
pt recv vax 19DEC95 & COD w/ruled sudden infant death synd by the coroner;a blood test taken @ the autopsy revealed a positive hepatitis B surface antigen;There is no family hx of hepatitis;early infect-poss false positive;
The pt experienced seizures, elevated temp, couldn't swallow. 911 was called and pt was admitted to hospital. Symptoms have been ongoing with hospitalizations, brain surgeries, autistic regression, and pneumonia's. 60 day follow-up dated 09/27/00 state seizures are better controlled with medication. The parents state the pt is starting to make noises and walk again. Deficits seem to be domino effects fromt he seizure activity. Diagnosis includes mild GER
Fever, Chills, Nausea , pain and weakness Have NOT been that sick in over 20 years!!!
wrong product given Narrative:  Patient was contacted by phone the following day and reported no adverse events to vaccine.
Pain in right arm starting 2 days post vaccination. Still unable to lift arm. Has not visited a doctor as of 12/04/2005.
Major swelling; body pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Patient had no allergies to food, medication or other products. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 12:00, the patient experienced major swelling and body pain. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event major swelling and body pain were not resolved at the time of this report.   Information about lot/batch number has been requested.
Full body itching, swollen face and eyes. Treated with BENADRYL and prednisone. Patient is fine now.
Flu-like symptoms, severe stomach pain. Worsened next day and developed esophageal spasms. Spams only lasted minutes. Vivid dreams, nightmares for 2 nights. Patient tolerated and did not go to hospital/doctor office. Self-limited symptoms resolved after 2 days.
The day after the vaccine, participant had low grade fever of  101 F and vertigo-no medications taken.  At night patient got night sweats.  Fever and night sweats lasted 24 hours.  However, vertigo continued for 3 to 4 more days.  Participant decided to seek treatment for vertigo and did a phone consult with the doctor.  The doctor prescribed Meclizine 25mg every 6 hours.  Patient took the medication for 2 days. Vertigo went away after a week.
Tachicardia, restless night, severe weakness, strong headache, chills and sweating
patient reports pounding in chest. Palpitations. EKG shows a-fib and a heart rate of 138. Palpitations kept patient up at night, and she did not rest well because laying on her side increased the feeling of pounding in her chest. By 1130 on 9/8/21, she had converted to normal sinus rhythm per EKG.
1OCT98 noticed pruritic area mid line lower lumbar area & was examined by MD who found bubble type eruption 2-3;they were scabbed over & don't' itch;pt exp chest pain & hard to catch breath;
temperature excursion on 23 Apr 2019:; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130412, 2019SA130377 and 2019SA130410.  This case involves a 8 months old male patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 25-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was of actual medication error due to incorrect product storage.  It was unknown whether adverse event was experienced.  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.  List of documents held by sender: none.
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness  lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips.  Went back to bed. Later Sunday felt better.
The day after getting the vaccine, a constant ringing in the ears (aka tinnitus) began. It has not stopped for a month and is still going.
Less than 25 days between the first and second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days between the first and second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days between the first and second shot). On 09-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days between the first and second shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Erythema circumferentially 2/3, length is 1/3 - Induration 5 cm on left upper arm.
This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, developed possible myopericarditis six days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site and side not reported); TYPHOID VACCINE, Manufacturer unknown, (lot number, route, site and side not reported) and ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 12 January 2011. On 18 January 2011, six days post vaccination, the subject developed possible myopericarditis, considered moderate in severity, with a 30 minute episode of moderate chest pain, pressure, palpitations, tachycardia and severe shortness of breath (also reported as fifth evening post smallpox vaccination). The subject did not seek care. "Troponins" and electrocardiogram (ECG) were reported as normal on unspecified date. The subject was referred for possible myopericarditis. No follow-up was available. No treatments medications were prescribed. The stop date of adverse event and outcome was reported as recovered, resolved on 18 January 2011. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
mouth ulcers--several small ulcers on inside of bottom lip, duration 3+ days fever, chills, aches, nausea--duration 8 hours
That evening, he states he had chills. Then 3 episodes of loss of bladder control. Then on 10/12/12 he had pain in his left leg and couldn't put weight on it. Two days later he was fine.
Diarrhea started two days after I received the vaccine; I was going to the bathroom an average of 10 times a day, throughout the day and night. The frequency has improved, but I still have diarrhea (have not had a normal bowel movement since getting the vaccine).