chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt's appetite dropped as did his weight. He is still thin for his height. He became very aggressive for 2 years and that is just now starting to taper. His overall development was stunted. Diagnosed with Aperger's syndrome, gastroenteritis and constipation. *F/UP report on 3/31/03: Continued prob's w/appetite, weight gain, and aggression.*
Chills,4 hours later entire body aching. Tired, sleepy. Lasted approx 12hrs.
Fever : 100.6 F; Joint pain that ¨it is the worst thing she ever had¨; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever : 100.6 F), ARTHRALGIA (Joint pain that ¨it is the worst thing she ever had¨) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (patient takes Blood pressure pills¨.) and Heart disease, unspecified (patient takes¨Heart Medicine¨.).   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PYREXIA (Fever : 100.6 F), ARTHRALGIA (Joint pain that ¨it is the worst thing she ever had¨) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 16-Jun-2021 at a dose of 2 tablets. At the time of the report, PYREXIA (Fever : 100.6 F), ARTHRALGIA (Joint pain that ¨it is the worst thing she ever had¨) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs include pills for stomach, blood pressure, allergy and heart ache.   No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: home address provided.
Headache worsening over 24 hours, improving and subsiding after 72 hours.  Fever within 24 hours peaking at 103F and remaining there for 12 hours.  Dizziness at the same time as headache onset. Lasting approximately 36 hours  Chills lasting 6 hours.  Fatigue and body aches lasting approximately 48 hrs.
Pt received vaccination early in AM. Called later that afternoon and was itching all over. took Benadryl which helped.
Patient complained of chills and nausea approximately 10 hours after receiving vaccines on 7/1/04; vomited. Father states temperature taken about midnight was 103 degrees F. Patient continues to have low grade fever for at least 4 days. Instructed father on 7/2/04 to administer Tylenol every 4-6 hours, increase fluid intake and see physician ASAP.
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. In 2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). On 05-NOV-2012, the patient was back in the office for the second dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a registered pharmacist refers to an unknown number of patients of an unknown age. On an unknown dates, the patients were vaccinated with a single dose of ZOSTAVAX subcutaneously in the "back of the arm in the triceps region" (doses, lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Moderna Dose 1 9/15/21 (053E21A) COVID Positive 2/17/22  2/17/22: Patient is a 34 year old male patient with a past medical history of Gout, Seasonal allergies was admitted from facility with Diabetic Ketoacidosis. Pt was seen by his PCP today, lab and xray was done, was told to go to ED . On admission blood glucose was 1176. Patient stated that he has been having nausea, vomiting for the past 3 weeks. He stated that he was able to drink only Gatorade drinks and could not keep down any food. Associated symptoms include increased urination and increased thirst. He also complains on mild abdominal pain level 5 out of 10. He did not have any bowel movements for 5 days.  He denies any diarrhea, fevers. Denies any chest pain, shortness of breath, dizziness.  Vital signs on admission blood pressure 158/89, HR 110, pulse ox 98% on room air. Laboratory findings significant for Metabolic acidosis, acute kidney injury BUN 39, Creat 1.49, Na 128mmol, Potassium 6.2, AGAP 29, ALT 56, Mg 3.1, Phos. 5.1, ketonuria 40. Patient admitted to ICU and started on insulin gtt.  2/22/22: Patient is a 34-year-old male with past medical history of gout, non alcoholic fatty liver disease, and smoking.  He presented on 02/17/2022 after being sent to the ER by his PCP.  He had been evaluated by his PCP for nausea, increased thirst, and increased urination.  His blood glucose was greater than 1000. In the emergency department, patient was diagnosed with DKA.  He had no known history of diabetes at the time.  He was placed on GlucoStabilizer protocol and admitted to the ICU.  He progressed well.  His COVID-19 PCR was positive on arrival, but he was never hypoxic.  He was complaining of some shortness of breath, cough, and generalized weakness at the time that his COVID-19 PCR resulted, so he was placed on remdesivir.  He received 2 doses.  This was discontinued when his liver enzymes were later found to be elevated in the 200 range.  His elevated liver enzymes were felt to be multifactorial due to his DKA, COVID-19 infection, initiation of insulin, and remdesivir exposure.  We discussed the importance of abstaining from alcohol for the time being to help prevent further damage to his liver and prevent complications with blood sugar management.  He will need follow-up on his liver enzymes as an outpatient. Patient received diabetic Education while in the hospital and we worked towards finding an appropriate insulin regimen.  Patient was discharged on 02/22/2022 to continue his medications as reconciled and follow-up with his primary care provider.  Of note, the patient felt his gout was worse recently and was requesting prescriptions for both allopurinol and colchicine as he was previously taking this and was pain free.  These prescriptions were sent to pharmacy.
Narrative: Multiple pending lab tests obtained to r/o other sources of infection (STD testing) that could have led to clinical presentation. These lab tests have not yet returned. Given this reaction was in relation to COVID19 vaccine and led to hospitalization, felt important to document.
Information has been received from a healthcare worker concerning a patient who on 10/20/2004 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine.  On 10/21/2004 the patient developed a rash and swelling from the deltoid down to the elbow.  the patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.
can barely move arm; excruciating pain at bottom part of the elbow; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can barely move arm) and ARTHRALGIA (excruciating pain at bottom part of the elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (can barely move arm) and ARTHRALGIA (excruciating pain at bottom part of the elbow). At the time of the report, LIMB DISCOMFORT (can barely move arm) and ARTHRALGIA (excruciating pain at bottom part of the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  were not reported  Treatment was not specified
Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion) in a 63-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (Exhaustion). At the time of the report, FATIGUE (Exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information was provided. No treatment information was provided.   This case was linked to MOD21-072110 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-072110:
Pt went home laid down after waking up could not move legs, nap lasted 3 hrs. Had to use the help of his wife and son to move him to where ever he had to go. This lasted all night according to his wife. Better in the morning. Recovered next day.
Pt recv vax on 12/10/97; on 12/20/97 pt exp rash all over body; tx=Zyrtec
Swelling of supraclavicular lymph nodes - swollen to about the size of grape following 2nd COVID vaccination. Soft and moveable with swelling around the site at base of neck/above clavicle. Onset after high intensity exercise, reduced swelling with rest but, still present.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided). On unknown dates, as a direct and proximate result of the defective design of the ZOSTAVAX vaccine with which the patient was inoculated, the patient sustained serious personal injuries and related losses (unspecified), including serious physical injury and impairment; mental anguish; pain and suffering; loss of enjoyment of life; diminished capacity for the enjoyment of life; a diminished quality of life; loss of care, comfort, and consortium; lost wages; diminished ability to work; medical and related expenses; economic damages; and other losses and damages. As a direct and proximate result of the defective design of the ZOSTAVAX vaccine with which the patient was inoculated, the patient will continue to suffer such harm, damages, economic damages, and other losses in the future. The defective design of ZOSTAVAX was a substantial, proximate, and contributing factor in causing the patient's injuries. Additional information has been requested.
UrticariaPruritus 0.5CM SPOT NEAR RIGHT EAR ON HIS NECK THAT IS CAUSING SEVERE ITCHING Narrative:
One day, post vax, developed red, swollen, hard and non-tender swelling around injection site (about 4" X 3 1/2").
1. Fever for 6 hrs 2. Confused unaware of my location, unable to identify co-workers, fast heart rate, elevated BP, Tremors in injection arm and right leg , sweating treatment- sent to ER , Ct scan, ekg, blood work, eeg --- All normal   MRI of brain is scheduled Oct. 18, 2021  No longer allowed to drive for 6 months.
Rash, vesicles scattered on buttock, legs and face for 3 days.
22 year old female pt present today due to a LARGE lump on her left  armpit. Patient states has always had pea like pimple under arm  pit area but 2 weeks ago noticed growth and its is getting  bigger, Warm to touch from scale to 0 to 10 pt states pain is a 7, worried because her breast is also tender.  Patient admits took pfizer vaccine and  after first dose she develop a "bump under her axilla on left side, pt went to get second vaccine 5-17-2021 and used right arm due to the bump on left and now both axilla are hurting, swollen mildly and  pain in both breast.  NO fever, no pus , no erythema, mostly pain as per patient.
Red blistery rash in patches.   Dr. said it resembled shingles, but was spreading to more areas when treated.
This spontaneous report as received form a certified medical assistant refers to a patient of unknown age and gender. On 15-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
intestinal flu; Initial information received on 29-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who was having intestinal flu while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed intestinal flu (gastroenteritis viral) (unknown latency) following the administration of influenza vaccine.  The patient reported"Got all my flu shots & boosters,still got intestinal flu,so miserable."  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (intestinal flu).  At time of reporting, the outcome was Unknown for the event intestinal flu.
Received both Pentacel and IPOL vaccinations at the same time. As of the time I am filling out this form there are no adverse events at this time.
Patient had Cellulitis in the left upper am, hot to touch.  Redness and swelling (approximately 4cm)  Throbbing pain (6 out of 10 scale).
Next day stinging pain in arm, thought it was a spider bite. Became more painful in arm & neck. Had red streaking and went to hospital. Started on Benadryl & steriods. Better now.
Presented on 2/17  with shortness of breath with +COVID results on 2/14. CXR revealed pneumonia and pulmonary edema. Admitted with acute hypoxia and placed on Vapotherm. Started on dexamethasone, remdesivir, and baricitinib. Respiratory status continued to decline and intubated and placed on vent on 2/18. Started on cefepime and vancomycin. Started needing vasopressors but by 2/25 was off vasopressora and extubated with good O2 saturation. Remained tachycardica nd started on digoxin. By 2/27 noted increasing leukocytosis presumed from pneumonia and started on more vanc, zosyn and levofloxacin. Respiratorty status started to decline again. Family decided on DNR with no further interventions.
Information has been received from a physician referring to a non-pregnant female patient of unknown age who was allergic to penicillin and VIOXX (reported as vioxin). Regarding to medical history, the patient was pretty healthy. The physician reported that the patient was a skinny girl and very slender. Concomitant therapy included LOESTRIN 10mg and estrogen (unspecified). On an unknown date, the patient was vaccinated with the third shot of GARDASIL 9 (lot#, expired date, dose and frequency were unknown) for prophylaxis. The physician reported vaccine route of administration was "The way it's supposed to be administered". The physician reported that "the injection site wasn't painful or red, just a bump" and the arm was "swollen and lasted for a month". The patient did not seek any medical attention. No treatment was given and no lab diagnostics studies were performed. The patient recovered from the events on an unknown date. Additional information has been requested.
WEIRD EXTRA VIVID DREAMS; SORE ARM; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced weird extra vivid dreams, sore arm, and mild fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.   The patient was recovering from sore arm, mild fever, and weird extra vivid dreams. This report was non-serious.
No adverse effects were reported; on 11/02/2019 improperly stored doses of PROQUAD were administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 02-NOV-2019, improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S007074, expiration date 06-SEP-2020) (lot # S017245, expiration date 01-DEC-2020) (strength, dose, frequency and route were not reported) for prophylaxis (improper storage of product in use) were administered.  Temperature excursion was -6.6 Centigrade for 1 hour 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.  This is a non-valid case due to lack of patient's identifier and number.
Varicella rash 2 weeks after Varivax in this basic military trainee-required hospital isolation and observation. Treated with Famcoclovir.
Approx. 5.25 hours after shot I began to have chills and another 15-20 mins. later uncontrollable shivers set in.  I went to bed @ 8:00 pm (to try and sleep it off)  covered with 4 blankets (1 heated) and that continued approx. 2 hours; followed by fever of 101.7 (my normal is 97.6) for approx.  6-8 hours; nausea set in about 3 hours into fever and over a period of 3 hours I vomited twice.  I stayed in bed sleeping until 1:00 pm on 3/23/21 and was fatigued until bedtime @ 10:30 pm.  After a full night?s rest I was well again.
incidental off-label use (adolescent); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incidental off-label use (adolescent)) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incidental off-label use (adolescent)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incidental off-label use (adolescent)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs are not provided by reporter.
The evening of 5/13/21 pt experienced light headedness, tired, hot/cold flashes; headache, nausea and vomitted once which continued until the evening of 5/15/2021.  Has been ok since.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site erythema, vaccination site swelling and vaccination site pruritis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date,  8 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  After 8 days, the patient experienced the events vaccination site erythema, vaccination site swelling and vaccination site pruritis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Myalgia, CoughWheeze, burning eyes, sneezing, chills, lethargy Narrative:
pt developed a headache after injection. she was monitored for 30 min and returned to work .she completed her shift at walmart and i called her several hours later but she still had headache. pt will monitor and seek medical attention if needed.
COVID break through Case. I received my 1st booster on 11/26/2021 and my COVID symptoms started on 03/08/2022  it started in the after noon with difficulty breathing, tired, chest congestions, heart raced fast. It was worst when I used my rescue inhaler (albuterol). Tested positive with PCR test on March 7/2022. I called my doctor with telehealth and he prescribed me with a inhaler which I reacted to but I used inhaler all kinds and never reacted. So I had to use a new generic inhaler instead. When I switch to new inhaler I was better.
Pt received Pfizer x2.  Pt tested COVID + on 10/1/21 and admitted to hospital for COVID on 10/1/2021. Pt receiving remdesivir and dexamethasone.
Individual presented at the  mass vaccination site for a COVID vaccination.  Stated needing the first dose.  After receiving the shot remembered this was the second dose and presented his vaccination card.  Recorded both vaccinations in system, and provided a new vaccination card.  Kept for 30 minutes, no adverse reactions, education on symptoms to monitor and seek medical help if needed.  First dose on 03/04/2021.  If that day is included in counting days to second dose, then it was administered on day 17 which falls within the grace period.  If the count begins on 03/05/2021, then the event is reportable.
Started with urticarial rash on 2/13/16 in the arm, progressing to face and swollen eyes later in the day. No fevers, no vomiting. Still with minimal rash on 2/18.