chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden roaring  in right ear. The roaring  later turned into a ringing sound. This did not come on slowly. It was an immediate roaring sound as I sat at the table working on the computer one night. I saw an ENT the following day. He stated there was no visible reason why I should be having issues with my ear. He saw no fluid, no pressure and no wax build up. He stated it could be the onset of high frequency hearing loss. I have never had issues with my ears in the past, no infections and no roaring or buzzing. He did put me on 10 mg of Prednisone and the roaring and buzzing has ceased for the most part. I completed the last dose yesterday. Occasionally I will experience a quick roaring or buzzing sound, but it goes away quickly.
Patient became short of breath, broke out in full body rash/hives reported tightness in her chest and throat. Lung sounds diminished.   Patient evaluated by paramedic , vitals taken, oxygen applied, Epi Pen administered in right leg. Patient condition improved by the .EMS unit arrived on scene, transported to Hospital.
Patient given vaccine at 17 years and 8 months of age when he should have been 18. No adverse effects noted day of vaccine or following day when staff called to check on him.
Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tiredness, couldn't get up, Sunday felt same way and called in to work, Monday weakness in both legs, went to work, today under arm is still sore. When i rub on deodorant underarm is very sore, left arm feels funny. Today still have migraine,  i started Tylenol on Thursday, by Friday evening i was taking tylenol every 6 hours until yesterday. I used medicated over the counter pouch, put hot cloth under arm for swelling and it did go down some, but is still not back to normal.  Everything i was feeling was on my left side, by Saturday whole body was aches, continued taking tylenol but now just left arm is sore. Migraine comes and goes. My doctor told me this morning she experienced everything i told her.
Large hive at injections site extending to elbow area on 1/06/2022.  PCP notified and was instructed to take Benadryl q 4-6 hrs.  Seen by PCP on 1/10/2022 hive had subsided but still there.  Instructed to continue Benadryl until completely resolved.
mom stated pt breaking out in chicken pox p/known exposure two wk prior;MD office protocol for chickenpox reviewed;
I had sore arm and swollen lymph nodes. It was for a few days and then it got better.
Slight dizziness/I am now dizzy when I lay down; Knees getting weak; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-years-old female patient receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Reportedly, on an unknown date patient took historical vaccine dose 1 BNT162B2 for COVID-19 immunisation. The patient reported that I am concerned because I didnt have any problem with either dose until the 18Apr2021, had slight dizziness and knees getting weak and it gets worse everyday. I am now dizzy when I lay down. Patient asked what should I do next. No PQC was present. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial report was received on 20 March 2014 from a consumer who is also the patient's parent. A child had received the following vaccines: Dose 1, 2, and 3 of PENTACEL, lot numbers C3193AA, C3434AA and C3434AA respectively on 03 July 2009, 28 August 2009 and 19 October 2009 respectively; TRIPEDIA, lot number U397AA on 05 October 2011 and DAPTACEL, lot number C4050AA on 25 November 2013, and an unspecified amount of time later developed Autism. According to the patient's mother, "My kids came down with ADHD and Autism after receiving vaccinations. They now have to see a psychiatrist and are on lots of medications. My kids father and I do not have these disorders so it's not something that is genetic". She also reported "that her three children and her boyfriend's two children all have experienced issues after receiving their normal childhood vaccine. Her 9 year-old son has Asperger's and has attempted suicide, her 13 year-old daughter has ADHD and has attempted suicide and boyfriend's has two sons age 11 who have autism. All of the children have anger management issues, learning disabilities, high levels of anxiety, depression and experience insomnia. No further information was reported. Outcomes were not reported. Documents held by sender: none.
Reaction to PROQUAD on left thigh - Red, warm, hurts to walk on leg - decreased appetite.
Extreme fever and chills to the point my entire body was shaking; nausea; pounding headache and total body ache; completely robbed of strength and all this lasted until the next morning at about 9am I started feeling some better but not well.  Today I am getting back to normal but it has affected my appetite and sense of taste.
pt recv vax 4MAR96 & 10MAR96 pt to MD w/malaise, weakness, & rhinitis;19MAR96 t103, chills, rhinitis, facial pain;21MAR96 sore throat, facial pain, adenopathy;tx amoxicillin;mouth pain, jaw pain, 10lb weight loss, herpes simplex;
p/vax pt w/lethargy & sl tremors of extremities;dx by ER MD infantile spasms cause unk;adm to hosp then transferred -in ped neuro x 24hr;EEG;dx DTP immun rxn;
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 29-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
A cluster of fever Blisters on outside left corner of my upper lip, received the 2nd dose of Shingrix on Tuesday around 1:15pm, felt tingling at first started on Thursday,  then tiny fluid-filled lesions appeared on Friday.
This spontaneous report as received from two pharmacists via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (strength and dose were not reported) with lot # N005605 and expiration date of 08-APR-2018, intramuscularly for prophylaxis. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1805USA006170.
Patient broke out in a rash two days after administration of the vaccines. She had no fever, dyspnea or apneic episodes. Describes rash as macular papular reddish over arms and legs, not hive like in appearance, accompanied by itching. Antihistamine prescribed on 02/11/05.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  None of the patients have reported side effects, so far.
a rash that is delayed after an injection of Moderna anywhere from 3-7 days after; This spontaneous case was reported by a physician and describes the occurrence of RASH (a rash that is delayed after an injection of Moderna anywhere from 3-7 days after) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (a rash that is delayed after an injection of Moderna anywhere from 3-7 days after). At the time of the report, RASH (a rash that is delayed after an injection of Moderna anywhere from 3-7 days after) outcome was unknown.        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.   Physician wanted to know if there is a documentation on delayed reactions and if the patient should get the second dose of the vaccine. Concomitant medications were not provided. Treatment information was not reported.   This case was linked to MOD-2021-023363, MOD-2021-021213 (Patient Link).
pt recv vax 28APR98 & approx 5min later fainted according to father;nurse heard a thud & ran out into hallway father reported pt fainted backwards & hit head;was assessed;BP 112/78, pulse 80, pupils equal;had h/a;
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/23/21 (EN6204) Pfizer Dose 2 4/13/21 (EM9809) COVID Positive 9/1/21  9/1/21: 73-year-old male with a past medical history of CHF, CAD, recurrent left pulmonary effusions, pancreatic cancer status post Whipple procedure presents with worsening shortness of breath.  Of note patient was recently hospitalized for similar issues. Patient says after discharge he was feeling fine but started to developed shortness of breath and decreased appetite over the last 3 days.  Spoke to patient's daughter who stated that the patient had not been following dietary restrictions and had not been moving around much since discharge.  VNA Services did check with the patient after discharge.  Patient had been exposed to COVID during this entire time.  In the ED the patient had a positive COVID test and imaging showed bilateral pneumonia.  Patient will be admitted for evaluation of COVID.  9/11/21: Patient was admitted on September 1, 2021 for evaluation of bilateral COVID pneumonia.  Patient received a full course of remdesivir, 5 days of Decadron, 7 days of azithromycin and Rocephin.  Initially the patient was maintaining moderate oxygen supplementation starting at 3 L and was titrated down to 1 L. On the evening of day 6, the patient began to require additional oxygen supplementation and by day 7 the patient was requiring BiPAP.  Cardiology was consulted on day 5 and recommendations were to try to titrate Lasix down as the patient was improving at that time.  Due to a developing positive fluid balance Lasix was increased.  Nephrology was consulted on day 9 for worsening AKI and recommended that the patient may need hemodialysis in the near future.  Pulmonology was contacted and updated throughout the entire hospitalization and was formally consulted on day 10 and recommended that due to the patient's poor prognosis, against intubation and initiation of comfort care.  On day 9 the patient was made DNR with intubation.  Facility was contacted on day 10 due to the family's request and declined a transfer request. On day 10 the patient was started on Zosyn and Diflucan due to worsening leukocytosis and a wound culture taken during the hospitalization was positive for yeast; Infectious Disease was not available for consult the during this day. On day 11 the patient was noticed to have agonal breathing and the patient's daughter was contacted and made wishes for the patient to be a full DNR/DNI.  The patient was pronounced dead on September 11, 2021 at 10:45 a.m.
Left arm and shoulder swollen. Bright red. Vomiting. Both hands were swollen.
Patient reported that on 11Apr2021 (about 4 days after the first dose), she developed COVID-19; This is a spontaneous report from Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that on 11Apr2021 (about 4 days after the first dose), she developed COVID-19. Patient was asking if it is okay for her to push through with the scheduled second dose of the Pfizer COVID-19 vaccine today (28Apr2021). The patient underwent lab tests and procedures which included COVID-19 test: positive on 11Apr2021.  Outcome of event was unknown.   Information on the lot/batch number has been requested.
Febrile seizure, high T 102. Vesiculopustular erythematous rash on face, oropharynx, trunk and extremities.
Information has been received from a physician concerning a patient who was vaccinated with a single dose of ZOSTAVAX. It was reported that two days after vaccination the patient developed rash. The physician stated that she was unsure if the rash was due to the vaccine. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
T of 104.3 for 3 days, refusing solid foods, no rash normal physical exam, mild URI, no rhinorrhea.
not receiving the second dose on the recommended time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving the second dose on the recommended time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving the second dose on the recommended time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving the second dose on the recommended time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No other medication reported.  Patient hang up before being transferred to the MI agent MI agent called back and no one answered. A voicemail was left with the case number.
This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of the Moderna Covid 19 vaccine) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1st 037K20A / 2nd 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 24-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 31-Oct-2020 and the estimated date of delivery was 07-Aug-2021. On 24-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of the Moderna Covid 19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of the Moderna Covid 19 vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. No treatment medications provided by the reporter. The patient's positive pregnancy test was on 26-Nov-2020 and estimated date of conception was 11-12 Nov-2020.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
4 hrs after vaccination developed a 103 temperature which lasted for 3-4 hrs then broke. Felt sort of disoriented the next few days.
Reaction after minutes of shot in arm. Half of face and neck/chest turned bright red and felt like they were on fire. Pain at injection side. Overall fatigue, extreme muscle soreness, nausea, diarrhea,  and temp of 99.9.
Case number PHEH2015US002903, is an initial spontaneous report received from a Healthcare Professional on 06 Feb 2015. This report refers to a 59 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412801) intramuscularly at a dose of 0.5 ml on 12 Dec 2014. It was reported that before administration, the FLUVIRIN was stored at 34 degree Fahrenheit for 15 hours. No adverse event was reported following this maladministration.
No additional AEs; PROQUAD was accidentally administered to a 17 year old patient; This spontaneous report was received from Medical Assistant, referring to a 17 year old male patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 13-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5ml/once, strength, route, lot# and expire date were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse events or product quality complaints were reported.
This serious initial spontaneous case was received on 23-Nov-2017 from a Pharmacist, concerns a 13-year-old, male patient. It was reported that, the patient had no relevant medical history and had not received any relevant concomitant medications. On 09-Nov-2017, the patient was administered with INN Flu vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, trade name, manufacturer and expiry date: not reported). On 10-Nov-2017, one day after vaccination, the patient experienced bloody stools and his stomach hurted for 2 days. It was reported that, the patient was not given any treatment medications. On 12-Nov-2017, the patient recovered from the events. The reporter assessed the case as non-serious.
Got my vaccine on Saturday 04/10, today 04/14 I start feeling pain in both of my arms this morning, is a weird feeling like I feel my veins, I had a hearth pain,  as soon as I wake up I felt a headache, I had it all day, on the left side of my head and after on the back area, it stoped around 6 pm, in the day I had diarrea, fatigue, pain in my joints, shortness of breath, pain in my arms and in my legs, itchy skin .
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 24-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as 5B23A, dose was unknown) intramuscularly which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
pt recv vax 14JUN96 & 3JUL96 pt exp arthritis in knees, a high sed rate, fever, swollen knees, & arthralgias in feet;
sore left arm; stiff left arm, stiff neck; muscle spasm all over the body inlcuding his stomach muscle was contracting; stomach upset; blurry eyes; could not keep his balance; chills (no fever); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset) and VISION BLURRED (blurry eyes) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset), VISION BLURRED (blurry eyes), BALANCE DISORDER (could not keep his balance) and CHILLS (chills (no fever)). On 21-Feb-2021, PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset), VISION BLURRED (blurry eyes), BALANCE DISORDER (could not keep his balance) and CHILLS (chills (no fever)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
10/18/06 mother called clinic this morning and stated that pt began experiencing nausea and dizziness while in shower. Rechecked on pt after 4 hours and mother stated symptoms had begun to subside. 10/19/06 spoke with mother who stated pt had a Headache in the morning but subsided in the after noon and pt was returning to normal.
2 days p/vax pt exp a sz-like event;pt was taken to the ER where 2 partial tonic-clonic sz of the upper extremities were noted;pt recovered w/o tx & was sent home;
Patient had rash on face, neck, forearms, and back 10/12/13. Referred to private MD if rash continues.