chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure. I found my son on the sofa, twisting his body, pale, sweaty, weak, confused, and staring into space. I had to call 911.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender. On 06-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72  hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient fainted and hit head on floor upon fall. Paramedics were called. He was cleared of a concussion.
Feeling tired; Headache; Low fever (99); No appetite; Vomited 2 times; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 at 17:00 (Lot number: FK5618) at the age of 7 years as dose 2 (TRIS), single for COVID-19 immunisation. Relevant medical history included: "Peanut allergy" (unspecified if ongoing), notes: Known allergies: Peanuts. Concomitant medications included: PROBIOTIC; OMEGA 3; VITAMIN D3 and FLUORIDE. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE; Lot Number: FK5618; Administration time: 18:00; Anatomical Location: Left arm; Route of administration: Unspecified), administration date: 07Dec2021, when the patient was 6 years old, for COVID-19 immunisation.  The following information was reported: FATIGUE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Feeling tired"; HEADACHE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Headache"; PYREXIA (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Low fever (99)"; DECREASED APPETITE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "No appetite"; VOMITING (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Vomited 2 times". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was unknown whether any therapeutic measures were taken as a result of the events. The patient's mother called her pediatrician and was advised to hydrate the patient with water or Gatorade and give her food if she can tolerate it. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness.   Initially I noticed my knees hurting with radiating pain up into my thighs.  My head hurt, particularly at the back of my skull, near my neck.  My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder.  I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms.  She told me I could take either and alternate if I felt I needed to maximize relief.  I noticed the joins in my toes and fingers were hurting.  It was frightening to experience tightness in my chest and back muscles.  I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted.  I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get.  I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse).  I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding.  She encouraged water and more painkiller.  As the day wore on, I felt less achy and more shaky/jittery.  My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy."  As I write this 36 hours after my injection, my symptoms are subsiding.  Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body.  It isn't a fever - just an odd sensation that something is still going on.
On 16 Sept 2010, patient broke out with a rash on forearms around 11AM. She started having hot flashes, chills. Temperature was 99.1F. Patient noticed bumps on face, neck and arms. By the afternoon, bumps increased and were on chest and legs. Temp retaken 99.9 F. Patient took BENADRYL around 2pm and itchiness subsided. BENADRYL taken again around 1730 and she continued to do so all weekend every 3-4 hours. Resolved 20 Sept 2010.
Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient had an allergic reaction and was hospitalized (name, address and phone number unspecified). At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
No adverse symptoms reported; improperly stored vaccines were administered to patient; This spontaneous report was received from a nurse referring to a 12 months old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       It was reported that on 03-DEC-2019, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 18-FEB-2020, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-1912USA001555: US-009507513-2006USA003314: US-009507513-2006USA005616: US-009507513-2006USA005620:
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On approximately 1996 (reported as 20 years ago) the patient was administered a series of RECOMBIVAX HB injection (lot#, dose and route of administration not provided) at the following scheduled: 0, 2 and 16 months later. This was outside the current recommendations. No adverse effects reported. No PQC involved. No concomitant therapy reported. Additional information has been requested.
First vaccine of the Pfizer I had shortness of breath/chest discomfort and the other side effects from it and I did fine,  Then then for the 2nd series 2 days later, I developed the same symptoms + cough and since then my cough has not improved and my pulmonologist, Doctor instructed me to put in a VAERS.  I am a complicated asymptomatic who after being infected with COVID 19 has severe cough in which after many months of treatment by Doctor, my cough got better but after the 2nd vaccine of COVID 19 the cough came back.
Developed discomfort left side of body after injection L deltoid.  Developed over an hour with left jaw & neck aching.  Slight difficulty swallowing, no respiratory changes.  Rec'd 25 mg Benadryl from paramedic per her request.  States she felt better in about an hour.  Called client 11/15/07 pm, stated she felt better after Benadryl.  Called 11/16/07 at work, sl. residual.
Patient suffered massive heart attack with 100% blockage of Left Main Coronary requiring CPR, shocking, Cardiac Cath and stent placement.
Ears are ringing / tinnitus /ears are so loud some days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears are ringing / tinnitus /ears are so loud some days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Ears are ringing / tinnitus /ears are so loud some days). At the time of the report, TINNITUS (Ears are ringing / tinnitus /ears are so loud some days) outcome was unknown.            The patient would like to get the booster, her gynecologist recommended it but she was afraid of it.  No concomitant medications were reported  No treatment information was provided
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. Since unspecified dates in October 2014, the patients were vaccinated with doses of improperly stored VAQTA (unknown strength and route) (incorrect product storage). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to pharmacy with large bruise at injection site with large area surrounding site red and inflamed.
Patient was given 3rd anthrax dose 4 months too early. The second was received on August 18th, 2021. No adverse events experienced from patient.
Swollen, dry, itchy lips with yellow tiny pimples that are wet to the touch. This occurred on December 19th at around 11am and I received my booster shot on December 10th. I also had swollen and dry lips when I had the second moderna dose but that time I did not have yellow pimples or raised bumps.   My doctor prescribed me steroids yesterday to reduce the swelling but the yellow bumps are not going away
(R) arm blistered area erythema - raised edema - tender to palpation. Improved with ibuprofen. Symptoms developed about 48 hours after vaccine administration.
This case was reported by a healthcare professional and described the occurrence of seizure in a 13-year-old male subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline). The subject had none concomitant medication, medical history or past drug therapy. On 3 September 2014, the subject received 1st dose of HAVRIX pediatric (.5 ml, unknown route, right arm). On 3 September 2014, 5 minutes after vaccination with HAVRIX pediatric, the subject experienced episode of syncope followed by seizure. This case was assessed as medically serious by GSK. The subject was kept in the physician's office and his blood pressure was monitored. On 3 September 2014, the events were resolved. Follow-up information received on 08 December 2014 from a nurse: Some VAERS details were updated. The patient's events were witnessed. The events were not preceded by aura or headache and the patient did not lose consciousness, he remembered the event, he did not experienced urine/faecal incontinence. There was no evidence the symptoms may have resulted from withdrawal of alcohol or other psychotropic substances. In the past, the patient did not receive any medication which was known to reduce the seizure threshold. The patient's medical history did not included seizure (febrile seizures and epilepsy), movement disorder, head injury, cerebral palsy, neurological handicap or congenital abnormality, diabetes, renal failure, alcohol or drug abuse or other CNS conditions. The vaccination with HAVRIX pediatric was discontinued.
I am flipping out more than I ever have with anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "I am flipping out more than I ever have with anxiety".  Additional information: The patient got the vaccine. The patient wants to detox and want it out. The patient did not want it in system anymore. The patient said if the patient dies in between the time, you guys will be haunted. The patient did not even get a flu shot. The patient was frustrated from this because if the patient did not get it and the patient cannot perform any of freedom and rights. The patient was flipping out more than ever have with anxiety. The patient wanted to know how to get this out of the patient system. The patient just got it today, around evening 3 o'clock and the patient want it out. The patient got the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx. 24 hours, post vax, the pt's left arm became red, swollen and sore which went down his arm. He saw a physician and was placed on antibiotics which resolved his symptoms. The physician told him that because the redness went down his arm and was not just localized, that it was a staph infection. No culture was done to confirm staph.
Pfizer COVID Vaccine EUA: Formulation/Dosage Error. Patient received Pfizer vaccine on 3/5/2022. The product provided on 3/5/2022 was 0.3 ml of the adult formulation.
Severe ear ringing, headache, gross mouth, raw throat, diarrhea, nausea, exhaustion, blurred vision, dry skin/chapped lips, cold sore
No adverse reaction to dose 2. Nurse administering contacted Dr. prior to administering the vaccine due to vaccine is not authorized for 15 year olds. Nurse found dose 1 was administered in error on 3/20/2021 lot EN6205. Mom reported that "someone approved it the first time." Doctor approved dose 2 after confirming dose 1 was recorded as given in the immunization registry. Doctor told nurse to give the vaccine and report a VAERS due to child is only 15. Mom reports child had a slight headache after dose 1 and a metallic taste in his mouth. She reported on 4-13 that following dose 2 he had a sore arm and so far no other symptoms.
MOM STATES HERSELF, DAD AND PATIENT WERE RIDING IN THE CAR AND PATIENT STARTED MAKING A WEIRD GURGLING SOUND, MOM TURNED AROUND AND SAW DROOL COMING OUT OF HER MOUTH AND THEN SHE MADE THE SOUND AGAIN SO MOM AND DAD PULLED OVER. DAD GRABBED HER OUT OF THE CAR SEAT AND SHE WAS LIMP AND STILL DROOLING, DAD SHOOK HER AND CALLED HER NAME AND SHE STARTED BECOMING COHERENT. DISCUSSED AS SEIZURE ACTIVITY.
3 days after receiving vaccination, I developed hives all over my body.  I continue to have breakouts even now.
Macular rash on torso (front and back) 2 days after injection. Tremendous pain in arm of injection the night of receiving and very red and swollen.
This spontaneous report as received from a physician refers to a 23 years old female patient with rash on her hands, most likely from a cosmetic and no pertinent medical history, who 3-4 months ago, in March 2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) and no adverse experiences reported for the first dose. On 07-JUL-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 07-JUL-2012 "within one hour" the patient noted pain in her ovaries as well as lower back pain; later that evening she experienced fever, vomiting and diarrhea and went to the emergency room. The patient was treated with ibuprofen and LEVAQUIN. Her platelet count was 101,000 when testing was done in the emergency room and 100,000 group B strep was noted in a urine sample. The patient was not admitted to the hospital. On 08-JUL-2012, the patient was seen at the physician's office and he noted that she was feeling better and was afebrile but her platelet count was 8,500. The patient was seen again in the physician's office on 11-JUL-2012 and the patient was experiencing diffuse stiffness as well as muscle pain and the patient might go to the emergency room again. At the time of the report, the patient's outcome for 100,000 groups b strep in a urine sample, muscle pain and diffuse stiffness was unknown. The relatedness for patient noted pain in her ovaries, patient experienced muscle pain, diffuse stiffness, patient had 100,000 groups b strep in a urine sample, patient experienced diarrhea, vomiting, fever and lower back pain was unknown for GARDASIL. Additional information has been requested.
hives on face & back, site of inj swollen;p/1st inj pt noted redness & swelling @ the site & soreness;hives appeared approx 24hr p/inj;
On Saturday 9/4/21 in the evening after she received her covid shot, the patient had numbness in her leg below the knee.
Rec'd vaccines at routine well check. On 4-6-07 was at day care. Worker heard a fall, did not witness so unsure if she fell and then had seizure, or if seizure/syncope caused fall. She was unconscious, eyes rolled back, fist clenched then moving (flexing) rhythmically at wrists/elbows. Duration 10" before regain consciousness.
Got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from January 2021 to an unknown date for an unknown indication.   On 06-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Non-Significant Follow-up received: Consumer calling back in to update pregnancy registry form. She wanted to add pregnancy doctor and most recent tests received.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 79-year-old male patient who received Shingrix for prophylaxis. On 18th June 2018, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, 1 day after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved. It was unknown if the reporter considered the shoulder pain to be related to Shingrix. Additional details were provided as follows: The patient received the 1st dose of Shingrix in the right shoulder. The patient claimed that after about a day or two of receiving injection, he experienced a feeling like someone punched him on his shoulder. There was a consent for follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2018GSK231617.
p/vax pt devel an inj site rxn characterized by redness, warmth & swelling extending below the knee;
6 inch long 2 inch wide rash on the right upper arm around injection site. Red borders with a white center. Looks similar to hives.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient experienced unspecified injection site reaction. The outcome of injection site reaction was unknown. Causality assessment was not provided. This is one of several reports received from the same source. Additional information has been requested.
No additional AE/PQC details provided.; PNUEMOV AX 23 was administered to 2-3 male patients today; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 23-SEP-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration were not reported; lot # T010779, expiration date reported as 30-JAN-2022). No additional adverse event details provided.  According to the reporter, the vaccine that was stored in their refrigerator that broke and reached a temperature of 68 degrees Fahrenheit for 12 hours on 21-SEP-2020 (product storage error), without any previous temperature excursion; which was detected by a digital data logger.  This is one of two reports form the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T010779; expirationdate: 30-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA010049:
Rash over left thigh; White blisters/bubbles over thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over left thigh) and BLISTER (White blisters/bubbles over thigh) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 07-Mar-2021, the patient experienced RASH (Rash over left thigh) and BLISTER (White blisters/bubbles over thigh). At the time of the report, RASH (Rash over left thigh) and BLISTER (White blisters/bubbles over thigh) outcome was unknown.            No concomitant medications were provided.  Treatment medications were unknown.
5mins post vaccination pt had an episode of vomiting Vitals: 14:17 (sitting) 79/49, 64, 13, SpO2 100% Temp 98.2F -- > (supine) 89/48, 74, 12, 100%, 98.2 -- > 14:30 94/52, 76, 13, 100% 98.1 Pt stable and released from the vaccination clinic.