chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced sharp chest pain on right side that woke me up 2:07 ish am Oct 25 2021 took ipuprofin at 2:40 am, pain subsided at 5:00 am, went back to sleep 10:00 AM noticed pain returned, went to walk in at health center they gave me a combo of antacid (over the counter) and antispasmic (need to be perscribed) and said it was most likely an esophagal spasm. Prescribed Dicyclomine HCl 10 MG CAPS, to be taken 30 min before eating because pain became worse while eating. Took this for about a week until pain subsided.
very sick; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender patient who experienced very sick , after receiving vaccine INFLUENZA VACCINE.  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 VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient developed a non-serious very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (very sick).  At time of reporting, the outcome was Unknown for the event very sick.
Seizures, twitching eyes, drooling, smacking lips, trembling, blue around lips and eyes, eyes rolled back and jerking limbs. Had 4 seizures on 12/26/00 and was hospitalized for 7 days. Seizures followed on 1/2/01 through 1/5/01 and was hospitalized for 5 days. Seizures followed again in late February.
I received the Moderna vaccine on a Monday 3/8th and by Tuesday 3/9th  I had big red patches that were burning and very painful that started on my  left arm. It kept getting worse every day and kept spreading down my arm. I wondered if it was infected so I went to the doctor Friday . I also had a huge lump on my neck on my lymph node and it was also very painful and swollen.  The doctpr prescribed  to me an antibiotic- Cephalexen . I started it right away and each day the pain and burning was going away. It's alot better now. I still have a few days left to take the antibiotic.
EPILEPSY, UNSPECIFIED 3/23/2023 URINARY RETENTION
Patient is a previously healthy 4 year old boy who presented with new-onset seizure in the setting of one month altered behaviors, fevers, and cough. On 12/15 patient received the MMR, VZV, and DTaP-IPV vaccines (verified in CAIR). Soon after he developed fever, cough, and rhinorrhea. These symptoms lasted for approximately 2 weeks, resolving 12/30 or so. On 1/12 symptoms returned again with fever and cough. He became fatigued and moody, refusing to get out of bed much, seeming weak and refusing to walk. Fevers were daily, both daytime and nightime and with associated chills/sweats. He saw his pediatrician about a week later and was diagnosed with viral illness. On Thursday 1/15 he again saw his pediatrician, was diagnosed with possible ear infection, and prescribed "ear drops." On Saturday 1/17 he developed rapid, fast breathing and had emesis x1. He presented to ED and discharged home with Tylenol for presumed viral illness. Around 4 PM the day of admission (1/22) pt and mom were at auntie's house. After eating some soup and water pt had emesis x 1 (NBNB) and seemed to slump down in chair. He was breathing differently, as if trouble breathing. Mom asked if he could see her and he said it was hard to see. He then seemed confused and was difficult to understand. Soon after, eyes seemed to roll up into his head and his upper and lower extremities became stiff. Parents called EMS at that point and he was brought to ED. In addition to daily fevers and cough for the last 3-4 weeks, patient has also had intermittent abdominal and back pain as well as headache. He has seemed extra sensitive, occasionally complaining that walking is painful, and seems to be walking more slowly than usual. He has had normal appetite and apart from two episodes of emesis (x1 on 1/17 and x1 on 1/22) he has had no other vomiting or diarrhea. No rashes. Parents do report weight loss, dad estimates approximately 8 pounds, despite no change in appetite.  In the past month parents have also noticed changes in patient's behavior overall. He has been more moody and fatigued than usual, intermittently confused. Specifically, in addition to the episode that occurred on 1/22 just prior to admission, mom recalls him waking up around 5 AM on 1/19 confused and asking "Where am I?". Mom was able to re-orient him at that time. Patient arrived to ED seizing and was given Ativan. Labs were sent, CXR and CT head done, and he was started on vancomycin, ceftriaxone, and acyclovir at meningitis dosing. He was then admitted to the PICU. Since arrival to the PICU he has had brain MRI which showed 3 small enhancing (necrotizing?) lesions. He was initially intubated for airway protection but has since self-extubated himself. Additional labs were sent. He has required precedex drip as well as other medications for sedation. He was continued on antibiotics sent from the ER, and started on oseltamivir as well.
Patient's upper right arm swollen, red and inflamed below the injection site almost all the way to the elbow.
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven years old patient (gender unknown) who received a 0.5ml dose of FLUBLOK QIV, lot QFAA1833, expiration date: 30-Jun-2019 via unknown route in the right thigh on 07-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse event following vaccination. 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. List of documents held by sender: none.
7-10 days after PNEUMOVAX 23 administration, pt. complained of nagging ache/pain at injection site. Discomfort comes and goes. Denies redneess or swelling. Area is painful when pressure applied.
The patients primary care physician notified the pharmacy 8/4/21 the patient went to the emergency department  8/3/21 the evening he received his COVID vaccine with a severe nose bleed.    It happened with the first dose also, but at the time didn't think it may be related to the vaccine until after the nose bleed occurred with the 2nd dose.  Patient was treated in the ED and released.
Vaccine administered. Patient got up and ambulated to the check out desk. While there, he began to feel faint. He went to the bathroom and vomited. The nurses assisted him to ambulate to the nearest exam room and lay down. He stated that he blacked out. The nurses gave juice, crackers, and a cool washcloth. His blood pressure after that was still 88/54 in a sitting position. APRN was asked to see the patient at that point.
Information has been received from a registered nurse, concerning a 19 year old female patient, who on 21-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #0469U). Concomitant therapy included Yasmin. On 22-JUN-2007, the day following vaccination, she developed a fever of 102F, and had dizziness, nausea and muscle aches. On 25-JUN-2007, the patient's symptoms were improving, though her temperature was then 100 F. The patient sought unspecified medical attention. Additional information has been requested. Additional follow up information was received from the nurse. It was reported that the vaccine series was discontinued for this patient.
PC from pt 2 1:45pm. Reports that she has tightening in throat; denies SOB. Also reports having some chest congestion and cough that start 2 hours after flu administered. Was seen by her PCP. Was given Steroid/Ihhaler to help with with wheezing. Resolved completely with 24 hours.
Staring at ground a lot, sad, fussy, would not make eye contact, was smiling though
contracted Covid; first vaccine in January and did not get second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 and PRODUCT DOSE OMISSION ISSUE of first vaccine in January and did not get 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.    In January 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 COVID-19 and PRODUCT DOSE OMISSION ISSUE first vaccine in January and did not get second dose. At the time of the report, COVID-19 outcome was unknown and PRODUCT DOSE OMISSION ISSUE of first vaccine in January and did not get second dose had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter. No treatment medication provided by the reporter.   Reporter did not allow further contact
Initial report was received on 17 October 2013 from a health care professional. A six month-old male patient with a history of GERD had received on 14 October 2013 a first dose intramuscular right thigh injection of FLUZONE QIV, lot number U4479AA; a third dose intramuscular left thigh injection of PENTACEL, lot number C4485AB and third dose intramuscular right thigh injection of PREVNAR, Pfizer lot number G57196 and on 15 October 2013 developed vomiting and had a two pound weight loss. The patient was evaluated by a physician and was admitted to the hospital on 17 October 2013 for IV fluids (not otherwise specified). The mother stated that the patient had a little cold at the time of vaccination. The patient was taking PREVACID. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Weakness initially, then hallucinations of seeing people who were not real, on 11/29/2015.
Got sick as a dog; Initial information received on 14-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got sick as a dog while receiving vaccine INFLUENZA VACCINE.  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 VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "got sick as a dog" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got sick as a dog).  At time of reporting, the outcome was Unknown for the event got sick as a dog.
Is it normal to still have symptoms after 4 days?; 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 VACCINATION COMPLICATION (Is it normal to still have symptoms after 4 days?) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Is it normal to still have symptoms after 4 days?). At the time of the report, VACCINATION COMPLICATION (Is it normal to still have symptoms after 4 days?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
On 2/4/21 after receiving my second dose,I started having some minor itching at the injection site when I returned home from the appointment around 7:30pm. On 2/5/21, the injection site was painful, red, very swollen, firm and raised. I also had accompanying symptoms of chills, dizziness, and a headache. Over night I experienced a hot flash lasting a couple of hours. On 2/6/21, the injection site looks bigger, is raised  and firm, hot to the touch, and painful. I still have a slight headache and dizziness. I have taken Tylenol through the course of the past few days which has helped the headache. I have also tried icing the spot for swelling and it continues to remain hot to the touch. I believe my symptoms are associated with Covid arm.
Patient developed a rash around and near injection site a few days after vaccine administration. Patient went to the urgent care where she was prescribed cephalexin.
VACCINE ADMINISTERED ON 06/12, PATIENT TARTED HAVING SYMPTOMS ON 06/14 TH MORNING WHEN SHE WOKE UP, SHE HAD HIVES LIKE RASH AT THE SITE OF INJECTION, SWOLLEN EYES, PAIN IN THE ARMPITS AND COULD NOT LIFT HER ARM
Within 6hrs extreme facial redness with burning which went away after a few hours. Next day temp (101 degrees) muscle aches & headache. Patient missed work.
8cm x 8cm erythema and slight swelling and warmth to Lt deltoid.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
body aches; Migraines; upper respiratory cough; congestion; Extreme muscle cramps; increase gi issues (gas); General fatigue; chills; sleep disturbance; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 13Mar2021 10:00, (at the age of 65-years), as single dose for COVID-19 immunisation. Medical history included glaucoma and hypothyroidism. It was unknown whether the patient had any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included SYNTHROID, EFFEXOR, AZOPT, ROCKLATAN; all from unknown dates taken for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in left arm on 20Feb2021 14:00 (at the age of 65-years), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 14:00, the patient experienced body aches, migraines, upper respiratory cough, congestion, extreme muscle cramps, increase gastrointestinal (GI) issues (gas), general fatigue, chills, sleep disturbance all lasting greater than 1 week. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, migraines, upper respiratory cough, congestion, extreme muscle cramps, increase gastrointestinal (GI) issues (gas), general fatigue, chills, sleep disturbance were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
Leg hurts; Chronically fatigued; Head hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg hurts), FATIGUE (Chronically fatigued) and HEADACHE (Head hurts) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031E21A) for COVID-19 vaccination.     .  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg hurts), FATIGUE (Chronically fatigued) and HEADACHE (Head hurts). At the time of the report, PAIN IN EXTREMITY (Leg hurts), FATIGUE (Chronically fatigued) and HEADACHE (Head hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Headache, chills, body aches, tired, swollen, sore  and blotchy injection site  , night sweats,  ( today is day 3), loss of appetite
Patient is a 78 yo M with hx paroxysmal atrial fibrillation, dilated cardiomyopathy with systolic and diastolic CHF, arthrosclerotic heart disease, mixed hyperlipidemia, moderately differentiated invasive ductal carcinoma of the left breast in a male s/p bilateral mastectomy, history of alcoholism and peptic ulcer who presented with lethargy and seizure like activity. No reported focal neurological deficits. Patient did have some visual loss that was improving early in hospitalization. Patient found to have bilateral occipital lobe and right cerebellar stroke. Patient started on ASA, continued eliquis, lipitor. Patient with worsening lethargy and respiratory acidosis in PM on 2/6. Suspect multifactorial in setting of ativan from CIWA protocol, COPD. Patient intubated on 2/6 after patient did not improve with BiPAP. Patient started on steroids. Patient has been on precedex and fentanyl for sedation. After intubation patient was noted to have seizure like activity with vertical nystagmus and jerking of extremities. Patient loaded on keppra and started on 500 mg BID for maintenance. STAT EEG and did not show epileptic activity on 2/7 or 2/8 but patient having intermittent seizure like activity. Keppra increased to 1000 mg BID. Routine exam may have not captured event. We cannot do continuous EEG monitoring at or facility. No recurrent episodes since increasing keppra. Hospitalization also complicated by Afib w/ RVR. Tikosyn discontinued due to QTC prolongation and diltiazem gtt started 2/7.  Pt transferred for higher level of care to hospital on 2/8.
Child received Varivax 01/11/2002 and 02/12/2002. She presented with about 10-15 pox lesions on head, face, arm, and abdomin. Recovered with no problems. The follow up received on 4/11/03 states the child received Varivax on 1/31/03. On 2/13/03 she presented with approximately 10-15 pox lesion on head, face, arm and abdomen.
Information has been received from a registered pharmacist concerning a 63 year old female with diabetes and chronic obstructive pulmonary disease with no drug allergies who on 29-OCT-2006 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included LIPITOR, NOVOLIN, AMBIEN, DUONEB, albuterol, REGLAN, potassium (unspecified), TOPROL XL TABLETS, furosemide, gabapentin, and PREVACID. On 31-OCT-2006 the patient experienced fever. At the time of the report, the patient was considered to be not recovered. Unspecified medical attention was sought. Additional information has been requested.
a flare up of multiple sclerosis (MS); autoimmune conditions were "going crazy"/ "several autoimmune things that were going bizarre"; This is a spontaneous report from a contactable consumer (patient) reported for self. A 77-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, 2 weeks following the injection, she is still experiencing a flare up of her multiple sclerosis (MS). She explained after getting the second dose, she was "down for a week then everything went away".  She specified this booster caused her a lot of problem with her MS, and all her autoimmune conditions are "going crazy". She also described it to the DSU agent as "several autoimmune things that are going bizarre". She explained prednisone is the only thing that currently alleviates her symptoms. She mentioned she continues to take her allergy shot every two weeks and her MS treatment, Betaferon, every other day. Caller suggested that we find ways to minimize adverse reaction from the booster shot, such as her multiple sclerosis flaring up. She reinforced her suggestion explaining that this may be a vaccine that will be administered yearly or more frequently, thus we must come up with something. Seriousness criteria was assessed as medically significant for both the events.Therapeutic measures were taken as result of events included Betaferon for multiple sclerosis and prednisone for several autoimmune things The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Area of pneumonia vaccine site started itching on my way back to work and continued the rest of the day so bad I first called the Dr. office around 12 noon. They was ok, just take some Benadryl and if it gets worst go to ER. Well continued into the evening and I finally could not stand it any longer and by then my arm was hurting and now it was swollen and throbbing.
On 8/26/02, pt reported adverse  rxn following 7/23/02 HBV #1 injection. Was seen at hospital ER for "anaphylactic reaction: lips were swollen, turned almost inside out; throat itching and felt like it was closing; given 2 shots."  "No food eaten that night cause a problem."
Felt generally unwell, lethargic. Had pain in my lungs when taking my dog  for a walk.
t104.3 started @ 6PM that noc;  t103 on 8NOV93 swollen glands & spots, swollen glands; both sides red & 3" redness on DTP; 1DEC93 pea size lumps in the groins;
During the wait period after administration, he developed a rash. The nurses took him to the back room to monitor him and the rash was spreading. It spread to his upper thigh but not at the injection site. It went from his upper thigh to his neck, just the core body though, not the arms. They had him go to the ER. It was hard to tell if he was in distress because he is a baby so he couldn't tell us what he was feeling, but he started rubbing his rash and his eyes. The ER told us to give him BENADRYL and discharge him since the rash was no longer spreading. In the morning he was red in the skin but it has since then faded. The ER believes it was more a virus rash, not hives. He did not have a rash before taking the vaccine.
pt recv vax 10JUL98 lt deltoid & onset of pruritus, warmth 11JUL98 evening;cont redness, warmth, pruritus;