chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Female 15-year old client received her first Pfizer shot (Lot# EW0185) at 15:02.  She was accompanied by her mother and 12-year-old sister, who was also vaccinated at the same station with her.  Client received her shot first and waited while her sister received her shot.  After both girls were vaccinated, they were walking with their mother down the hallway to the observation room.  RN1 stated that from the opposite end of the hallway she saw client?s knees buckle.  RN1 walked toward client to ask if she was OK.  Client straightened herself out, slumped onto her mother?s shoulder, and rolled onto her mother, who guided client to the floor.  At 15:09 Lead RN heard client fall to the floor, went out to the client, and radioed for EMT assistance. Client was conscious and turned her face up.  Client?s mother stated client passed out for 2-3 seconds and that her head did not hit the floor.  Client?s mother stated that she cushioned her fall.  Client was breathing adequately, appeared pale in face and lips, and stated she was OK.  Lead RN and RN1 kept client lying on the floor and elevated her legs on a chair.  EMT1 & EMT2 arrived at 15:10 and checked client?s pulse (HR:  74).  Client denied head, neck, and back pain.  Client was alert & oriented times 3 (person, place, & event).  Client stated she was OK to stand up and sit in a wheelchair.  Wheeled client to extra vacant breakroom where client vitals were taken by EMT2 at 15:17 (BP:  124/60, HR:  96).  EMT1?s assessment found the client exhibited good circulation, sensation, and motor function in all 4 extremities.  Client denied chest pain, shortness of breath, and nausea & vomiting.  Client was leaning forward in the wheelchair resting her elbows on her lap.  She stated she does not remember becoming nonresponsive and that she felt dizzy when lying her head back.  Client stated she has a history of anxiety and panic attacks and is currently taking Prozac.  Client stated she felt hot.  Client?s mother stated client ate a full lunch at 12:35. At 15:20 Lead RN provided client with a bottle of water.  Lead RN & EMT also observed client?s color returning to her face at that time.  Client sat upright and stated that she felt better and was alert & oriented times 4.  Client and mother declined going to the hospital and calling 911 for evaluation.  At 15:23 client was wheeled to the observation room with her mother and sister where she remained seated in the wheelchair for 30 minutes for additional observation by EMT1.  At 1600 EMT1 took client vitals while she was seated (BP:  116/82, HR:  68, RR:  16).  EMT1 took client vitals again while having client stand (BP:  120/86, HR:  72, RR:  16).  Client and mother stated they were OK to go home.  Client and mother were instructed by Lead RN to follow up with HCP if client experienced any additional symptoms after going home and to call 911 if client experienced SOB or any difficulties breathing.  Lead RN and EMT observed client leave the facility walking with a steady gait with her mother and sister.
Initial information was received on 28 October 2008 from a consumer. A 66 year old male patient with a history of enlarged prostate, acid reflux, allergies to CIPRO and NEOSPORIN antibiotic cream received an intramuscular left deltoid injection of FLUZONE (lot number U2742AA) on 26 October 2008 at 1:25 PM. The patient reported that he received FLUZONE on a yearly basis since 1999. He had similar symptoms in the past although the symptoms were not as severe. On 26 October 2008 at 5:30 PM the patient developed difficulty breathing, wheezing, coughing, couldn't talk and upper chest discomfort. At 6:30 PM the patient's eyes became gritty, white pus coming out of the eyes, eyes were blood shot and vision was blurred. At 7:30 PM his pulse was elevated. At 8:15 the patient was still wheezing but improved after he took BENADRYL. On 27 October 2008 his eyes were hurting and on 28 October 2008 his eyes were red. It was noted that the patient was seen by the paramedics but refused to go to the hospital. The patient was not recovered at the time of the report. List of Documents held by Sender: None.
This was the second Pfizer Covid shot, at 9:45 am. By 4 pm I had a very slight headache. By 5 pm I was starting to feel pretty tired/fatigued (I would call this moderate - fatigue has now continued to the next day). At 1 pm I had some period spotting and by 5 pm my period had started. This is highly unusual as I am  taking NuvaRing and it has only been two weeks since I put the NuvaRing in. I am 52, have been taking NuvaRing for 2.5 years and do not get regular periods. I switch out NuvaRing every three weeks in order to ensure I skip any periods.
Experiencing anxiety which is not normal for her, anxiety that has been debilitating; Crying/ sobbing; Sadness; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experiencing anxiety which is not normal for her, anxiety that has been debilitating), CRYING (Crying/ sobbing), DEPRESSED MOOD (Sadness) and FEELING ABNORMAL (Brain fog) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced ANXIETY (Experiencing anxiety which is not normal for her, anxiety that has been debilitating), CRYING (Crying/ sobbing), DEPRESSED MOOD (Sadness) and FEELING ABNORMAL (Brain fog). At the time of the report, ANXIETY (Experiencing anxiety which is not normal for her, anxiety that has been debilitating), CRYING (Crying/ sobbing), DEPRESSED MOOD (Sadness) and FEELING ABNORMAL (Brain fog) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
patient received improperly stored vaccine on 4/16/2019.; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.   On 16-APR-2019, the patient received one improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB), lot # R021078 and expiration date on 12-JUN-2021, for prophylaxis (route of administration and anatomical location were not reported).  The administered dose of the vaccine had a temperature excursion of 52.5 Fahrenheit degrees (°F) for 4 hours and 40 minutes, as recorded by a digital data logger. The vaccine had not had previous temperature excursions. No product quality complaint was involved.
covid 19; congestion; experienced brain fog; anxious; sick; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious) and ILLNESS (sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had already tested positive for Covid-19 before receiving the vaccines). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 11-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious), ILLNESS (sick) and FATIGUE (very fatigued). At the time of the report, COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious) and FATIGUE (very fatigued) had resolved and ILLNESS (sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: she tested positive for Covid-19 on 02Jun2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided
Headache, head cloudiness, body aches (generalized), chills, L side (arm at injection site, torso, neck, leg) pain
This initial spontaneous case, was received from other non-health professional on 16-Oct-2017, concerning a female 12 weeks pregnant patient of unspecified age. On an unspecified date, the patient was administered with INN Flu Vaccine (dose, route of administration, batch number, expiry date, anatomical location, manufacture and trade name: not reported). On the same day, the pregnant patient was administered with the vaccine (considered as vaccine exposure during pregnancy). At the time of this report, the outcome of the event was no reported.
Fever; wrong vaccine administered; Lack of effect; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Lack of effect), PYREXIA (Fever), COVID-19 (Covid-19) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown whether patient had any allergies to  vaccines, medication and food.  Previously administered products included for Product used for unknown indication: pfizer vaccine (side effects experienced with their Pfizer vaccine doses.). Past adverse reactions to the above products included Vaccination adverse reaction with pfizer vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced VACCINATION FAILURE (Lack of effect) and COVID-19 (Covid-19). On an unknown date, the patient experienced PYREXIA (Fever) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered). At the time of the report, VACCINATION FAILURE (Lack of effect), COVID-19 (Covid-19) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) outcome was unknown and PYREXIA (Fever) had resolved.            The year of birth of patient reported as 1974.  Concomitant products were not reported.It was reported that patient had received one Moderna booster and described a side effect of fever with the Moderna booster that "lasted slightly longer" than any side effects experienced with the Pfizer vaccine doses. The fever experienced following their Moderna booster was described as mild and subsided within half a day. Patient also had been infected with COVID (September 2022). Experience of symptoms with COVID was also described as mild, limited mostly to fever and cough. It was unknown if the event cause the patient to seek medical care.  Treatment medications were not reported.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID-19 in the context of booster dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also reported. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed.  Patient experienced fever after booster vaccination which was mild subsided in half a day and also had mild cough.  No further information on risk factors, investigations, treatment of the events, details of previous doses was available in the report. The outcome of the event covid-19 was unknown. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. The benefit-risk relationship mRNA-1273 vaccination is not affected by this report.
This case was reported by a physician and described the occurrence of consciousness decreased in a infant patient who received ROTARIX. On 11th December 2014, the patient received ROTARIX. On 11th December 2014, less than a day after receiving ROTARIX, the patient experienced consciousness decreased (serious criteria GSK medically significant). On an unknown date, the outcome of the consciousness decreased was unknown. It was unknown if the reporter considered the consciousness decreased to be related to ROTARIX. Additional information was provided: This case was reported by another manufacturer (Pfizer) and described an infant who stopped responding after receiving ROTARIX; therefore the other vaccines were not given.
This Shingles vaccination has been difficult. I received it on the morning of Tuesday the 28th, and became sick the night of the 28th and have slept pretty much all day Wednesday and Thursday with fever, severe headaches, nausea, and diarrhea. The vaccination site, upper right arm,  became large and inflamed, with a 4-in diameter red whelt. Today (Friday July 1) the fever and headaches have subsided, thankfully, but I still feel bad. The vaccination site is still painful and large, about 4-inch diameter.
48 hrs after vaccine had pain, induration, erythema 3 cm 2.
The second dose bivalent Covid vaccine  given on 7/08/2023 was outside of the recommended schedule. With the most recent guidelines, patients 5 years and older that have been vaccinated with a bivalent vaccine are considered completely vaccinated until they are 65 years old unless they are moderately or severely immunocompromised. This patient did not have  any exception noted for the second dose.
Information has been received from a healthcare professional (HCP), via a company representative, concerning a female patient (age not specified) who was vaccinated on an unknown date with a dose of Gardasil (lot # not specified).  The HCP stated that the father of the patient reported that his daughter had pain around the injection site.  At the time of this report, the outcome of the event was unknown.  No further information is available.
This spontaneous report was received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and expiry date were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning a 5 month old male who in approximately March 2007 ("3 weeks ago"), was vaccinated with his second dose of Rotateq. Subsequently (date unspecified) the patient has tested positive for Rotateq and was hospitalized. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Patient had a TIA  April 21, 2021.   He then fell and was in/out of consciousness for 14 hours on June 4, 2021.  He has had a severe decline in health ever since. He currently is on "hospice".  He has lost 50 lbs,, has orthostatic BP,  is having hallucinations and is dying.  Neurology has done a spinal tap, even sending samples to the clinic with no clear diagnosis. He is now too sick to be moved to any hospital.
Patient received Td vaccination on 7/20/2023 as part of his annual work physical.  Call received from employer on 8/4/2023 stating that patient is still experiencing mild arm pain.  Contacted provider for treatment recommendation. Provider recommends OTC ibuprofen or aleve for 7-10 days.  Attempted to contact patient to provide treatment recommendation. Unable to reach patient and unable to leave voicemail due to full inbox. Sent message to patient through EHR.
Constipation, exacerbation of hemorrhoids, 10c size clots, rectally after oral typhoid vaccines 3 of 4 pills. Pt HX= hemorrhoids, diverticulitis, Hiatal hernia
Positive covid test on 1/11 and negative tests on 1/13 and 1/15/2021. Considered a false positive Narrative:
Red, itchy rash around injection site; Red, itchy rash around injection site; Red, itchy rash around injection site; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK8729) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levocetirizine dihydrochloride (XYZAL ALLERGY 24HR) and ibuprofen (ADVIL); both taken for unknown indications from an unknown date and unknown if ongoing. On 10Apr2021 at 13:00, 2 days after administration of second dose red, itchy rash was appeared around injection site. Rash lasted about 6-7 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events red, itchy rash around injection site were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
7/26--8/2 50 y/o with a h/o CHF sarcoidosis, asthma, HTN, DM came in complaining of left lower back and left lower quadrant abdominal pain, onset one day prior to arrival. With associated polyuria, NV. Additionally, complained of productive cough, nasal congestion, and SOB. CT showed multiple bilateral calculi, with the largest being a 8 mm stone in the L ureter. Patient brought to surgery by Urology and had a cystoscopy with left ureteral stent placement. Copious amounts of pus was drained after stent placement. Patient was started on IV NS, Morphone, and Azo prn. Zofran was available for nausea and we started patient of low oxalate diet. Ca was WNL, Vit D 25 was low, but Vit D 50,000 U qweek was dc'd. Pain regimen was transitioned to Toradol, Norco, and Dilaudid. Patient did not have further urinary sx. Was instructed to follow up with Urology outpatient for stent removal and was sent home on Naproxen BID and short course of Norco.
Rash on face and both arms and a numb upper lip all within 30 minutes of receiving vaccination.No treatment.   Very easily bruised within the weeks that followed vaccination.
Mid-grade fever 100.6, chills, lower back ache (3) hours after 2nd shot March 29, 2021 at 3:30 p.m. EST. Symptoms lasted for 4 hours after taking 1000mg of Tylenol  March 30, 2021- Mid-grade fever of 100.5, chills, lower back ache, (24) hours after 2nd shot. Symptoms lasted exactly (4) hours again after taking 1000mg Tylenol. This is Wednesday March 31st and am hoping for no more.  Note: No symptoms in between fever and chills.
tinnitus. left ear feels plugged most days. sudden onset of springtime seasonal allergies.
Pt developed fever 104-105 within 24 hrs of receiving vaccine Adacel.
Pediatric Pfizer dose given for booster dose should have been Pfizer adult Pfizer dose.  Adult Pfizer dose given with proper formulation per CDC guidelines.
Night sweats, chills with sweaty armpits, horrible odor from my armpits, constant period and staining. Always have to wear a maxi pad. Restless nights. Lose of weight.
An Eye bleed in my right eye. Severe menstrual cramping and pain, that has persisted through my last 3x mensural cycles.
Patient was given the wrong dose for her age.  She was given the COVID vaccine for 12 yrs and up at age 11
59 y.o. F that lives at a group home 2/2 TBI w/ SAH, hydrocephalus shunt, G-tube dependent, seizure disorder and stoma w/o tracheostomy tube who was admitted from 4/29-5/2 w/ increased secretions and fatigue 2/2 COVID (vax x2, boosted) and was admitted for the same from 5/3-5/4. It was felt her primary issue was requiring frequent suctioning of her stoma given her increased secretions. Despite the group home providing their best efforts in this regard, she has continued to become more lethargic. She is confused at baseline but usually alert and can respond. Now, she is sleeping around the clock and has no muscle tone when they transfer her. During her initial hospitalization last week, ENT evaluated and recommended laryngoscopy for her narrowed stoma after she is out of isolation for COVID. Today in the ER she is more hypotensive than she had been previously, w/ Systolics in the 90s. She is also requiring 2L via NC to maintain saturations. During her previous hospitalizations a trach collar was used intermittently due to intermittent hypoxia.
itchy rash on arm; rash on back, stomach and waistline; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on arm) and RASH (rash on back, stomach and waistline) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (itchy rash on arm) and RASH (rash on back, stomach and waistline). The patient was treated with TRIAMCINOLONE for Rash and Itchy rash, at a dose of 1 % twice a day. At the time of the report, RASH PRURITIC (itchy rash on arm) and RASH (rash on back, stomach and waistline) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-219895, MOD-2021-219895 (Patient Link).
ER: PT STATES SHE THINKS SHE MAY BE HAVING SEIZURES. PT STATES 2 DAYS AGO SHE HAD AN EPISODE WHERE HER FEET GET HOT THEN GETS NUMB, THEN TRAVELS UP THE REST OF HER BODY. HER LEG GOES STRAIGHT OUT AND THEN HER ARM WRAPS AROUND HER HEAD AND SHE STARTS SHAKING. PT STATES HAD 4 EPISODES 2 DAYS AGO AND 2 EPISODES TODAY.
At about 3am on day following administration of shots developed lip smacking, with altered level of consciousness. Taken to ER abnormal EKG likely a true neuro onset seizure disorder, reporting only due to time frame.
Diagnosed with high blood pressure and prescribed Lisinopril 10mg on 04/22/2022. Diagnosed with blood clots and prescribed Eliquis 5mg (2X daily) on 05/16/2022.
This spontaneous prospective pregnancy report as received from a physician refers to a currently 17 years old female patient with Last Menstrual Period (LMP) of 23-JUL-2014 and Estimated Date of Delivery (EDD) of 29-APR-2015. On 22-AUG-2014, when the patient was 4 weeks pregnant, the patient was vaccinated with a first dose of GARDASIL lot # J006850 and expiration date 31-MAR-2016 (dose and route not reported). The patient had not demonstrated or reported any adverse effects. The pregnancy outcome was pending. Additional information has been requested.
I woke up this morning and could hardly move my left arm. My arm aches around the injection site and into my left shoulder, but mostly only when I move my arm. The discomfort was minimal after the date of the injection with just a little soreness, but is progressively getting worse. It hurts the most when I lift my arm to reach horizontally for things on a table while I am sitting.
Right arm numbness, swelling, pain for 4 days. Fatigue for 2-3 days.