chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/27/21 at around 10:30AM, 5 days after taking the first dose of the Pfizer vaccine, I was walking in the street and suddenly felt dizzy. I felt spinning and stopped to rest a bit. After awhile I felt better and continued walking. A few blocks away I felt tired and stopped to rest and sit on a bench and felt dizzy again. I returned home and felt tired, sleepy, and achy in my body. The dizziness lasted for maybe 30 seconds to a minute. The other symptoms last for about an hour or so. The next day I didn't have any of these symptoms.
The patient was vaccinated with expired vaccine ACT-HIB/No AE; Initial information regarding an unsolicited valid non-serious case received from an other health professional via Information (Reference number: 00467939) and transmitted to Sanofi on 09-Feb-2021.  This case involves a 16 month old patient who patient who received an 0.5 mL expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] [lot UJ28AA and expiry date: 07-Feb-2021] via an unknown route in the right thigh for prophylactic vaccination on 08-Feb-2021 [Expired product administered].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination.; and INFLUENZA VACCINE (INFLUENZA VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used [Latency: on the same day].  Product used : Used.  Still using product : No.   At the time of report, 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.
injection pain, nausea, dizziness, headache immediately following injection pain, swelling in underarm 2 days following injection  Continues to be problematic
Summer of 1995 finally dx MS;now extreme fatigue, substantial problems w/walking, occasional lt hand coordination problems, twitching legs, numbness feeling in lt hand fingers;balance problems, sensitivity to heat;
At hospital for COVID-19 vaccine. Vaccine dose was prepared in syringe by pharmacist, dose was transported to nurse station in medication box, when nurse picked up syringe noted needle was not tight on syringe and vaccine had leaked out into medical box, syringe and dose discarded, vaccine never reached patient, documented dose wasted
Dizziness, SOB, chest tightness, painful left nodule inflammation for 2 days, 7 days after vax. EKG monitor reflected PCV's - 6-7.
within 24 hours of shot  felt very tired and within 48 hours DOE followed by pain across lower chest with significant impaired ADLs for 17d prompting UC visit - CXR negative, COVID negative given fluticasone MDI & breathing/DOE improved but did not resolve; got 2nd vaccine 5/7; stopped MDI 5/16 due to stomach side effects but by 5/20 significant left sided chest pain eventually prompting ED presentation and admission 5/30
47 WM never-smoker with HTN and h/o MI x 2 (12/97 and 4/98) s/p PTCA of RCA and mid LCX, and family history of early cardiovascular disease, who presents to clinic as a transfer from Medical Center with concern for GBS secondary to recent influenza vaccine administration on 10/22/08. He had been in his usual state of health from that point until 11/15/08, at which time he developed bilateral paresthesias of his toes, then fingers, then the following day a continuous sensation of Left>Right LE progressive strength deficit, beginning in the feet, up to the knees, to the hips.  n 11/19/08, he developed Left-sided facial weakness and diminished sense of taste. Diagnosis of GBS. Please contact M.D. for additional information.   12/26/08-records received for DOS 11/20-11/25/08-DC DX: Guillain-Barre syndrome. Presented on 11/19/08 with C/O bilateral toe and finger paresthesias later progressing throughout day to include feet, knees and hips. Developed left-sided facial weakness and diminished sense of taste. Treated with IVIG. PE: absent patellar, Achilles and triceps reflexes. Complete left upper and lower facial paralysis consistent with cranial nerve 7 distribution. Discharged to rehabilitation facility.
Generalized chicken pox rash-initially had few pox and then next day, spread to entire body including scalp, torso, back, legs, arms. Otherwise, happy and content baby.
PAIN AT INJECTION SITE AND REDNESS, REDNESS AREA JUST GOT LARGER AND LARGER SO PATIENT WENT TO THE DR ON 7/29 AND WAS PRESCRIBED A MEDROL DOSE PAK.
Patient developed headache and nausea approximately 30 minutes after receiving the influenza vaccine. Symptoms continued until that night. All symptoms were resolved by the next morning.
Felt feverish, coughing, weakness, diarrhea for at least a month after injection. Symptoms progressed until victim of covid shot passed out and become unconscious on the evening of June 1, 2021. Victim went to the hospital and had a stroke, heart arrhythmia, and left side of his body paralyzed.
Information has been received from a nurse referring to a 33 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. The patient had an unknown vaccination or chicken pox history and showed low immunity to varicella. On 12-MAY-2016 the patient was vaccinated with a dose of VARIVAX (lot # K021486, 03-NOV-2016, dose unknown, subcutaneous). On 23-MAY-2016, the patient developed a varicella like rash on the back of her left arm where she was vaccinated. The patient saw an unspecified primary care physician. No lab diagnostics studies were performed. The patient had not recovered from the varicella like rash at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 same reporter, same vaccine, same lot number). This case involves a patient of unknown age and gender, who was vaccinated with a dose of Fluzone Quadrivalent (batch number: UI669AA, expiry date: 30-JUN-2017 and site of administration was not reported) via intramuscularly, on 04 October 2016 (over the past month). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On 05 October 2016 (also reported as "over the past month"), 1 day following the vaccination, the patient developed bouts of nausea, achy joints, and loose stools. On unspecified date (also reported as "over the past month"), following vaccination, the patient developed injection site sore and it was reported that injection site was not red or warm. It was reported that the patient required emergency room or doctor visit. Lab data was not reported. Corrective treatment was reported as no. The outcome of the patient was reported as unknown. List of documents held by sender: none.
Took oral Typhoid dose #1 4/3/14, dose #2 4/5/14, dose #3 4/7/14 and vomited pill up and 5 more times.
MOM CALLING TO REPORT THAT 08/12/2005 AT 11PM CHILD COMPLAINED OF RAPID HEART RATE, MOTHER CHECKED PULSE, RATE WAS 160 PER MINUTE, LEGS/THIGHS WERE CONTRACTING, DIZZY, DIFFICULTY BREATHING, GENERALLY NOT FEELING WELL. WAS TAKEN TO ER WHERE THEY EXAMINED THE CHILD AND DID BLOODWORK AND EKG. RESULTS WERE ALL NEGATIVE ACCORDING TO MOM.
Possible side effect related to blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Possible side effect related to blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Possible side effect related to blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Possible side effect related to blood clots) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant product information were provided by the reporter.  No treatment information was provided by the reporter.  Company comment Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Had an episode of Covid and she tested positive and had symptoms; Had an episode of Covid and she tested positive and had symptoms; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got her first dose on 31March2021 and then she had an episode of Covid and she tested positive on an unspecified date and had symptoms on 15Apr2021, and then she got a test yesterday on 15May2021 and tested negative for Covid. Reporter was asking if patient can get the second dose or she have to wait for 90 days. Outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.
I had a fever at first. It was low grade. I had a sore throat for two days and a vague headache. I had no respiratory problems except a cough. I had low energy for a week. By July 2nd, I felt good. We contacted our doctor. Our doctor prescribed PAXLOVID. The only side effect I had was a very funny taste in the mouth for the five days. I had mucus in the throat for a couple of weeks.
On Friday mother of pt brought her in to get her first covid vaccine, I did not double check the age and accidently gave the 5-11 pfizer dose for peds. When i vaccinated pt she did not have any reaction to vaccine GH
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 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 1:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:42 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.80.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 13-FEB-2021, no hourly temperature recordings available.  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 traceable 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  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's wife called to report that patient had fever of 101 on 10-15-16 and 100.8 on 10-16-16. Patient felt achy and had loose stools on 10-16-16.  Patient wanted this to be reported.
DTaP, Hib, IPV, Prevnar given at 4 PM 12/1/03. At 7:30 PM baby began crying then went limp, pale, with perioral cyanosis, fingers cyanotic, shallow resp about 10 minutes, pale for 1 hour. (Additional medical notes attached)
exposed to excursion and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adolescent patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: The nurse reported that in 2021, their Bexsero was exposed to 11 degree Celsius for 53 hours and 1.09 degree Celsius for 150 minutes with no prior excursions and the vaccine was administered to the patient. Health Care Professional (HCP) was not aware of patient gender when asked. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up by email. Additional Supportive Information: The patient had received a dose of Bexsero vaccine after temperature excursion, which had led to Incorrect storage of drug. This was one of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022150629:Same reporter US-GSK-US2022150631:Same reporter US-GSK-US2022150628:Same reporter US-GSK-US2022150627:Same reporter
Nausea/vomiting/chills. Left arm sore - no redness, no swelling, barely lift. 1/12/17 - could lift left arm, no redness, mild tenderness. No further nausea/vomiting.
Fever of 102 degrees F, chills, nausea; approximately 48 hours
About 5 minutes afterward had right arm and elbow tingling. About 20 minutes after vaccination had self-described sensation of throat tightness and tongue and lip swelling, and "numbness" but NO tingling. About 1.5 hours and symptoms ~90% better. Plan to continue to monitor until symptoms close to 100% better and patient comfortable going home.
3/19/2021 for 3 days hard coughing, slight tightness of chest and tired. Drank plenty of fluids and rested. Saw doctor 3/29/21.  Some coughing continued on and off after this. August 23 went to Urgent Care with trouble breathing and coughing. Put me on Predisone for 1 week, took Covid tests rapid and other - both negative.  Saw general doctor 8/30 and was going to put me on Advair, but did not get approval until 9/3.  Had milk protein, allergy to milk products on record, I did not take.  Went to Emergency room 9/4 coughing hard and some trouble breathing.  They took EKG, chest x-ray, tested for Covid rapid and other- both negative, gave me 2 nebulizar treatments and some predisone there. They sent me home on 2 weeks of predisone and to use rescue inhaler four times a day.  Saw general doctor 9/17 and they put me on Flovent inhaler and to use rescue inhaler as needed.  I was still using my rescue inhaler about once a day.         I asked to see a plumonologist.  Saw him 11/1/21.  He put me on Symbicort.  I saw him 12/28 and he said I could try going off if it.  If after two days, I did not have trouble, but if after 2 weeks, I did, he could change it to only one type of med.  I tried it and was able to go until the two weeks.  I started it back up.        I had my Covid booster shot 1/11/2022.   I finally was able to reach my doctor to change my medicine.  But I tried going off the Symbicort again and started coughing within a day.        I am stilll taking the Symbicort as of now.        The doctor gave me a Flovent disc inhaler with milk protein so I need to check with him on this.        I had allergies before all this, but only running nose with a sinus infection once in a while.  I used to have pneumonia once in a while, but not since about 1996.
pt recvd vax & 9NOV93 began exp severe pain in wrist & arms-shocking sensation/shooting pain; seen by MD on 11NOV93; pain worse now in legs & ankles; seen in ER 12NOV93; dx carpal tunnel synd; 19NOV93 seen by another neurologist;
MIGRAINE; DIARRHEA; BODY WAS SO HOT; FELT LIKE HAD COVID AGAIN; CHILLS; COULD NOT GET UP AT ALL; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 30-MAR-2021 20:00, the subject experienced migraine. On 30-MAR-2021 20:00, the subject experienced diarrhea. On 30-MAR-2021 20:00, the subject experienced body was so hot. On 30-MAR-2021 20:00, the subject experienced felt like had covid again. On 30-MAR-2021 20:00, the subject experienced chills. On 30-MAR-2021 20:00, the subject experienced could not get up at all. On 30-MAR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, migraine, nausea, diarrhea, body was so hot, could not get up at all and felt like had covid again was not reported. This report was non-serious.
About two hours later from injection, my right sinus became inflamed; skin became itchy and red. Started with my left arm and then spread to my chest and neck; skin became itchy and red. Started with my left arm and then spread to my chest and neck; This is a spontaneous report from a contactable consumer. This 32-year-old non pregnant female consumer(patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: E19266) via an unspecified route of administration in arm left on 21Feb2021 14:30 as dose 1, single (age at vaccination: 32 years) for COVID-19 immunisation. Medical history included known allergies: walnuts, cats, environmental, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination and did not tested covid post vaccination. On 21Feb2021 2:30PM, the patient experienced after first dose- skin became itchy and red. Started with my left arm and then spread to my chest and neck. About two hours later from injection, my right sinus became inflamed and stayed like that. Seems to be resolving slowly. Treatment received was benedryl. The clinical outcome of the events was resolving.   Follow-up attempts completed. No further information expected.
Light-headed, face flushed 11:36 am No rash, no itching, no SOB, chest tightness or wheezing Lied down, drank water, vital stable q5-10min  Discharged: 12:10pm - stable Home by car with husband. Walking unassisted. Given instructions for ER follow up if new or worsening symptoms
Arm swollen and black and blue at the site, 101 temperature  for 5 hours, chills  - took Tylenol and iced arm as of this date arm is start to go down bruise getting bigger starting to itch
Patient was found unresponsive on her kitchen floor about 9:45 AM on February 10, 2021 approximately 18 hours after receiving her first Covid-19 vaccination. Exact time of the event is unknown. She was known to get up between 6:30 and 7:30 AM. It appeared that she had not eaten breakfast nor taken any medication that morning. She was taken by ambulance to Medical Center where a CT scan showed an unrecoverable massive brain hemorrhage. She died at approximately 3:50 PM after the respirator was removed. She was sent to the local Medical Examiner afterwards.