chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A Student received the second dose of the vaccine 18 days from the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A Student received the second dose of the vaccine 18 days from the first dose) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A Student received the second dose of the vaccine 18 days from the first dose). On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A Student received the second dose of the vaccine 18 days from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication used were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up document  received contains No New Information
Patient reported symptoms of significant generalized muscular weakness with onset within 24 hours of vaccination.  Resulted in the inability to arise from the bed or to sit in a chair that following day.  Generalized weakness remained to a lesser degree for up to 9 months limiting his ability to do his normal daily activities.  Did not report symptoms to a healthcare provider at that time to allow for further evaluation.  Discussed during the course of a routine visit on date of entry of report.
24 hours, post vax, pt came back to office with redness and swelling of right thigh. No fever. Pt has been cranky. Treat with Tylenol and Motrin and warm baths to decrease swelling. Cool wash cloth to area of swelling. Call with any changes.
pt recvd vax & became unconscious, incontinent, folded up into the fetal position;arms were contracted @ elbows, legs were contracted @ knee & stayed in this position;jerking movement of entire body w/pallor x 90seconds
After 6 days of the shot my left arm felt very heavy and was hard to lift. Upper arm was quite swollen, red and rash going  down arm. Woke up with hives, itching, and tingling all over. This lasted for several days.
At the 25 minute mark I started feeling my left ?go to sleep? like when your feet go to sleep. It was tingling from should to finger tip. Since then I have had tingling on the left side of my face from my left eye straight down to the left side of my jaw. I can smile and speak and have full motion of my left side.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 10:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 03-Mar-2021, Excursion time was 09 Am, 10 AM and 1 PM. temperature was 51, 34 and 35. total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36 and 4 PM: 36.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient developed abcess of tooth and high blood pressure 2 days after receiving vaccine.  After getting blood pressure treated, pt had tooth removed.  Pt developed headache, stiffness in neck and upper back.  Pt went to personal physician who prescribe physical therapy.  Pt went to physical therapy X2.  Pain is better at this time, but unresolved.  Headache continue.  Pt taking Motrin for pain and headaches.
Administered one drop of ROTATEQ and baby projectile vomited. Waited a few minutes and tried another drop and the baby vomited again and became pale. We did not complete the administration of the vaccine and did not give the other vaccines. Baby reassessed and color improved and patient was well appearing.
Rash at site of injection and spreading further on the arm. Itching and redness as well. No blisters. No other symptoms.
36 hours after receiving a physical exam, which included administration of Adacel vaccine as well as placement of a PPD, patient complained of headache and vomiting.  She was taken to an ER where she was found to have a skull fracture and hemorrhagic brain contusions. It was concluded during her hospital stay that she most likely had a seizure.  05/28/2008 MR received for DOS 5/08-16/2008 with D/C DX: Intracerebral hemorrhage.  Pt awoke on 5/08/08 with severe L sided headache, nausea and vomiting and intermittant decreased responsiveness. Temporal bone fracture and subarachnoid hemorrhage noted on head CT as well as tomporal and frontal contusions. Pt developed low grade fever that pm. PEs were WNL during hospitalization.  Likely pt had seizure in her sleep resulting in fx and SAH. D/C on seizure precautions.
Redness, warmth, swelling started 2 hours after immunization.  Persisted for 3 days.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with an improperly stored VAQTA lot # M031806 for prophylaxis. The vaccine was exposed to 34.6 F for 10 hours.
Initial report received from a non-healthcare professional (patient's parent) on 07 January 2014. A 34-year-old male patient whose medical history, concomitant medication were not reported, had received a dose of Quadrivalent Flu Vaccine (therapy dates, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that on an unspecified date, the patient experienced sore throat, 102 fever, chest and nasal congestion, lethargic. Laboratory investigation and corrective treatments were not reported. At the time of this report, the patient was recovering from events. Documents held by sender: none.
Both right arm and left arm very swollen,red with rash and VERY painful the first day. The second day I had to stay in bed because of the fever,pain,rash, and general discomfort. I went back to wrk on the third day after the vaccines , however althought the acute had subsided the swelling had gone into my forearms and I began to experience runny nose, scratchy throat, and some chest congest and a horrible headache ( I rarely get headaches). I was told to continue to take the 800mg Ibruprofin and Benedryl and take the steroid s given as prescribed for 5 days on a graduated basis.
Patient exhibited swelling of the right side of lips and tongue. Patient was treated in the ER with antihistamines and steroids. Swelling resolved, and patient was released.
Within a few hours after receiving the shot, I became very tired. I started getting cold, and all my limbs felt like heavy weights. The next day I felt the same way, and had to go to work. After three days, I wasn?t cold anymore, but was still tired and my limbs continued to feel like heavy weights.  The feeling of being tired all the time and my limbs feeling like heavy weights, continued for three more weeks. During this time, my vision started getting fuzzy, and took several minutes to gain focus. I began taking B12 vitamins which helped me not feel as tired and my limbs began not to feel as heavy as they had, but my vision still continues to not to focus as well.
On Saturday, November 7 I awoke with an itchy, red rash around my neck, under my arms and on the bend of my elbows. I consulted a Dr. and started Benadryl.  On Sunday November 8 I had the same symtoms and by afternoon my ears were plugging and my eyes were slightly swollen. I went to a walk-in clinic and was diagnosed with an allergic reaction and put on Prednisone  20mg for 5 days. (Prior to all of this-Friday Nov.6- Chills, 100 degree temp, sore arm, headache, achey body-things I was expecting)
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked 2018SA271076, 2018SA271075, 2018SA271074, 2018SA271077. This case involve adult patient who received FLUZONE HIGH DOSE (Batch number, expiry date, route and site of administration were not reported) instead of FLUZONE QUADRIVALENT on an unspecified date. It was a case of actual medication error as Wrong vaccine administered, inappropriate age at vaccine administration and overdose as an employee below 65 years age who received the FLUZONE HIGH-DOSE instead of the FLUZONE QUADRIVALENT. Nurse stated that the nurse who was giving the injections picked out the wrong medication and administered to 5 employees who were not 65 plus age. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
This spontaneous report as received from a medical assistant refers to a currently 12 year old female patient with no medical history or drug reactions/allergies. The patient was vaccinated with dose 1 GARDASIL (date, dose, route, lot # and expiration date not reported). The patient also received MENACTRA and ADACEL at the same visit. Medical assistant reported that the patient became "a little dizzy" after her first vaccination with GARDASIL. The patient was vaccinated with dose 2 GARDASIL (date, dose, route, lot # and expiration date not reported). After the patient's 2nd vaccination with GARDASIL, she became dizzy and passed out. Since the 2nd vaccination the patient has developed nausea, stomach pains, anxiety and did not want to go to school. The patient's mom stated her daughter had had two of the three series of shots for GARDASIL and was experiencing nausea, diarrhea, constipation, stomach aches, tears in the morning on the way to school, dizziness, and when she ate it got worse. The patient contacted office to seek medical attention. The patient was treated with ZANTAC. No lab tests were performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Patient reported swelling, redness, and skin that was hot to the touch at injection site. It had started a few hours after injection. Swelling and redness had subsided considerably the following day from the evening when she received the injection. She was advised to receive any treatment at her doctor.
Flublok Quadrivalent was administered to 15 year old patient with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist  This case involves a 15 years old female patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1933, expiry date: 30-Jun-2020) via intramuscular route on 21-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Flublok Quadrivalent was administered to 15 year old patient.  At the time of reporting, no adverse event was  reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
pt recv vax 7OCT96 & on 10OCT96 c/o abd pain w/vomiting;t100.3 sent to hosp for 23hr eval;c/o abd w/nausea several days;mom thought could be rxn to flu vax;
The Patient and her twin brother both fainted after getting TDaP and MENACTRA. Both patients remained in our office for 20 min after episode. We elevated their legs, used cool compresses and gave cup of water. Vital signs taken and normal. Both patients recovered quickly and left office without incident 20 min later. Follow up phone call placed to father 4 hours later, father report both kids went home and took a nap. They ate lunch and are drinking fluids well. No further issues with dizziness or nausea. Off note today is a very hot/humid day, area is under heat advisory.
Starting right after 1st dose of vaccination, rapid heart rate, fluttering of my heart, chest pain, feeling of weight on my heart, difficulty deep breathing. It is becoming milder, but 4 days after the vaccination, it still exists.
Mom states that infant no longer could say "hi", "hair", and "I love you" which she could say before (meaningfully) which happened "immediately" after those shots.  I told her that since we don't expect infants at that age to say actual words with intention, I did not believe it was an adverse event.  Mom was adamant that I complete a VAERS report.  I told her to complete a form also. NO TREATMENT. Mom has refused any more Rotateq after first dose.  She received 2 PCV13 doses but has not returned for more.  She has had 3 doses of pentacel.  Otherwise growing/developing well.
Inconsistent heart rate (racing and feeling of stopping or skipping beat), shortness of breath, intermittent chest pain.  Heart races when laying down to sleep at night.
Systemic: Chills-Mild, Systemic: throat pain- no swelling. Just pain-Mild, Systemic: Hypertension-Mild, Additional Details: Checked patient's BP was 143/82 then 135/78 5 mins later. Could be due to anxiety
Pneumonia vaccine caused extreme pain in shoulder blade on the same side as the injection. Pain radiates down arm, in armpit, and seems to have pinched a nerve that goes into neck muscles. Unable to relieve pain with ibuprofen, heat and cold applied with no relief and it has been four days now.
Woke from nap, inconsolable (~1230pm) L thigh red & swollen to knee.  Came to office at 100pm.  Ice applied ibuprofen given (had TYLENOL 3 hours prior).
Site: Pain at Injection Site-Mild, Systemic: patient distracted me and quickly grabbed the vaccine off the table and injected his left arm. I did not complete in the system or fill out his card as I did not administer and did not know if he in fact got it or squirted it quickly.-Mild, Additional Details: I cannot confirm if patient received the vaccine or not. He turned his chair saying he wanted it in his right arm. He then asked if I could use the bandaid he just bought and I said sure. I was opening the box when he quickly grabbed the syringe off of the table and injected himself in the left arm lower than his deltoid. He had clicked the vanishpoint. I asked why he did that and he was laughing and said he thought it would be fun to do it himself. He watched the pharmacist do it last time.
only the liquid component of Pentacel was administered to patient with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient who reported only the liquid component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was administered to patient with no reported adverse event.  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 Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient reported only the liquid component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine was administered to patient with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported "wanted to know if they can revaccinate the patient".  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Information has been received from a physician concerning a 75 year old female with a history of lymphoma who in May 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot no. route and site of administration were not reported).  On 03-JUN-2008 the patient experienced shingles and was hospitalized.  However, the reason and length of hospitalization was unspecified.  The patient sought unspecified medical attention.  Additional information has been requested.
Within the first 48 hours after receiving the vaccine, I experienced a sore arm, some swelling, and itchiness at the injection site, but all of those symptoms went away by March 8th.   However, when I woke up on March 13th, I experienced swelling, redness, and itching again at the injection site, much worse than it was the previous weekend. It felt like two knots were under my skin, and my skin was hot to the touch. The redness spread significantly over the weekend, to where most of my upper arm is now red on 3/15/2021.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 11th May 2018, the patient received SHINGRIX. On 12th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain and influenza-like symptoms. On an unknown date, the outcome of the pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain and influenza-like symptoms to be related to SHINGRIX. Additional information received as follows: At afternoon the patient received SHINGRIX and the symptoms presented the next day of vaccination. The patient experienced feeling achy all over like he had the flu and lasted for 2 days. The reporter did not give consent to follow-up. The patient declined to provide address and phone number.
Information has been received from a 31 year old Caucasian female with no past medical history or allergies, who on 6/20/02 was vaccinated with a first dose of MMR (second generation) (lot # not given). Concomitant therapy included zolpidem tartrate (AMBIEN). The patient stated that two weeks after vaccination she found out that she was pregnant. An ultrasound done on an unknown date showed that she was 5 to 6 weeks pregnant. Unspecified medical attention was sought. Follow up information from a registered nurse indicated that the patient had a history of 4 pregnancies with two live births and an unspecified number of miscarriages at 12 weeks from her last menstrual period. The patient's last menstrual period was 6/18/02. The patient suffered from lyme disease during her pregnancy, but no onset date was provided. A list of medications taken during pregnancy included amoxicillin 500mg TID on unspecified dates for Lyme disease, miconazole nitrate on unspecified dates, meperidine hydrochloride on unspecified dates, and promethazine hydrochloride on 8/1/02. it was reported that a sonogram done at 5 weeks from the patient's LMP, on approximately 7/23/02, showed a 5 week sac. A sonogram done at 12 weeks from the patient's LMP, on 9/10/02 showed fetal demise and the patient underwent a dilation and curettage. Pregnancy outcome was noted as spontaneous abortion and it was reported as uncertain if the fetus was normal, had congenital anomalies or any other complications. It was further reported the patient had become pregnant again, with LMP of 11/12/02 and estimated delivery date of 8/27/02, and that she has had no problems so far with this current pregnancy. Additional information is not expected.
~15 minutes post vaccination, reported feeling sensation on right side of throat. Tightness, burning, swollen ("like strep throat, raw")  1515: Dose of 50mg capsule of diphenhydramine PO   Can swallow without difficulties Denies troubles breathing  15:25: Notes some improvement in symptoms, denies worsening  VS: 148/98
arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient's mother had shingles).   On 20th May 2022, the patient received the 1st dose of Shingles vaccine. On 20th May 2022, less than a day after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine on the date of reporting and felt like arm was killing him or her. The patients mother had shingles hence the patient decided to take the Shingles vaccine.
patient is complaining of bursitis with his 2nd dose - he is stating that his doctor thinks the shot hit his bursa sac -