chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021; fever; seizure; I feel so terrible but cannot afford to go to the hospital.; violently shaking; Now over 48 hours later I cannot eat or sleep; Now over 48 hours later I cannot eat or sleep; I have a terrible rash on my right arm where injected; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021 (Lot Number: CUS8955) at the age of 22-year-old as single dose for COVID-19 immunization. Medical history included Celiac and IBS. Known allergy include gluten. The patient didn't receive other vaccine in four weeks. The patient previously received Gluten and experienced allergy. The patient COVID prior vaccination. The patient didn't  perform COVID test post vaccination. Concomitant medication included multivitamin once a day. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 24Jul2021 at 04:00 PM at the age of 22-year-old as single dose for COVID-19 immunization. On 15Aug2021 at 03:00 AM, with the second dose however, he woke up violently shaking almost seizure like at 3 am the morning after receiving second dose. Now over 48 hours later he cannot eat or sleep. The patient have a terrible rash on right arm where injected. He had difficulty breathing and worse symptoms than previously contracting COVID 19; when it first began In February. This was he being a voice advocating for those without healthcare assistance. He felt so terrible but cannot afford to go to the hospital. The only symptom that has subsided has been the fever. Everything else was just as bad as when it first began. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of inappropriate schedule of vaccine administered was unknown. The outcome of fever was recovered. The outcome of other events was not recovered.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. Patient has not had any signs or symptoms after the vaccine. patient appears to be well in her health. Family will be contacted and informed of the incident. Family will be advised to have patient come back in for revaccination.
The syringe was taken from our tote of pediatric syringes. It was opened and labeled as a pediatric shot, but no volume of the vaccine was actually inside of it yet. Instead 0.1mL of air was administered into pt's left arm and arm of his brother. After the 2nd "blank" immunization, I realized the mistake and quickly gave actually vaccine doses to both children in their opposite arm.
Area of erythema and induration at vaccine site with center pustules. Treated with KEFLEX.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 71 or 72 year old. The reporter had called earlier in the past and reported the adverse event that her husband experienced with 1st dose of SHINGRIX. For tolerance of 2nd dose refer linked case US2019041406. This case has been linked to case US2019041402 and US2019GSK043645, reported by same reporter (For patient's wife).
Left knee became swollen and very stiff; Left knee became swollen and very stiff; Painful to walk; knee is still tender and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 at 18:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Osteoarthritis all over my body, but my knees have it more mildly. The patient took concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: FC3180,, Prev dose administration time: 05:30 PM, Prev dose dose number: 2,, Prev dose vaccine location: Left arm), administration date: 13Aug2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: FA7484,, Prev dose administration time: 05:30 PM, Prev dose dose number: 1,, Prev dose vaccine location: Left arm), administration date: 23Jul2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: JOINT SWELLING (non-serious), JOINT STIFFNESS (non-serious) all with onset 25Feb2022 at 22:00, outcome "recovered with sequelae" (2022) and all described as "Left knee became swollen and very stiff"; PAIN (non-serious) with onset 25Feb2022 at 22:00, outcome "recovered with sequelae" (2022), described as "Painful to walk"; ARTHRALGIA (non-serious) with onset 25Feb2022 at 22:00, outcome "not recovered", described as "knee is still tender and sore". Therapeutic measures were not taken as a result of joint swelling, joint stiffness, pain, arthralgia.  Additional information: It was reported that about four hours after the 3rd dose of the COVID vaccine was received, my left knee became swollen and very stiff. It felt like my knee had been stuffed with cotton. I was unable to bend it fully, and it was painful to walk and go up and down stairs. It took about 10 days for the worst of it to go away, but it never completely resolved. It has been two months now, and the knee is still tender and sore, and quickly becomes painful when going for a walk. I do have osteoarthritis all over my body, but my knees have it more mildly and were not an issue before the booster dose. I plan on consulting an ortho doctor about it in the near future. Patient had No COVID prior vaccination and neither tested post vaccination. Patient did not have any Known allergies. Patient received unspecified medications in two weeks of vaccination.
Information has been received from a medical assistant referring to a 14 month old patient of unknown gender. The patient had no drug reaction/allergies. On 26-OCT-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L007226 with expired date 17-MAR-2017, subcutaneous). No concomitant medication was taken. On an unknown date in 2015, the patient had been sick and was admitted to a hospital. On 01-NOV-2015, the patient developed a lesion in an unspecified area right before discharge. An option to test the lesion was given and performed on an unspecified date. The test result for the lesion was still pending. No treatment was given. Varicella zoster virus (VZV) packet was declined. At the time of reporting, the patient was recovering. Additional information has been requested.
Information has been received from a nurse concerning a 56 year old male patient who on 12-APR-2011, was vaccinated with a dose of 0.5 mL PNEUMOVAX 23 intramuscularly, in the right arm (lot number 667445/0993z, Exp. 05-JAN-2012). On 14-APR-2011, the patient was seen in the doctor's office with a severe headache. At the time of the report of the outcome of the patient was unknown. Follow up information has been received from a registered nurse concerning the patient with no illness at time of vaccination, who on 12-APR-2011 at 10:00 was vaccinated with a first dose of PNEUMOVAX 23. On 13-APR-2011 (previously reported as 14-APR-2011), the patient experienced 3 days of erythema upper arm, aching, fever < 100 degrees and moderate to severe headache. There were no Lab diagnostic/studies performed. The patient recovered on 16-APR-2011. No further information is available.
After receiving vaccines, patient was directed to sit in designated post-immunization observation area for 15 minutes.  While seated, patient became light-headed and lost consciousness, causing him to fall from his chair to the floor. He regained consciousness within moments and experienced no additional symptoms.  In course of falling from the chair, patient sustained a head injury, causing a minor scalp laceration.  Paramedics were summoned.  Patient declined transport to medical facility, and was urged to seek follow-up care for the injury to his head.
Moderate pain at injection site: Started within 6 hours of injection, lasting 36 hours. Felt like severe bruising. No visual signs.   Minor Fatigue: Started within 8 hours of injection. Lasted 36 hours. General tiredness. No visual signs.   Minor to Moderate Aching: Started 12 hours after injection. Lasted for 24 hours. Whole body aching pain with minor chills, felt like I was coming down with a cold or flu. No visual signs.   All adverse events were most pronounced the morning after injection, and had mostly subsided the morning after that.
Information has been received from a physician concerning a 6-month-old female with no medical history or allergies who on 15-SEP-2006 (Lot #655082/0779F), 02-NOV-2006 (Lot #655174/0848F) and 08-JAN-2007 (Lot #655407/1115F) was vaccinated PO with the first, second and third doses, respectively, of ROTATEQ. Concomitant vaccinations administered on that same day included a dose of PREVNAR, a dose of PEDVAXHIB and a dose of PEDIARIX. The physician reported that two and a half weeks after receiving the third dose , on approximately 25-JAN-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. While hospitalized, the intussusception was corrected without surgery by a "contrast procedure." The patient was hospitalized for an undetermined length of time and released on 15-MAR-2007. The patient was considered to be recovered. The physician also considered the intussusception to be an other important medical event due to the "contrast procedure." Additional information has been requested.  6/25/07 Received vax record from pcp which confirmed RO dose & lot # as reported.  Also provided additional info on other vax received same date.  VAERS database updated w/same.  7/20/07 Received t/c from reporters office w/MRN & corrected dates of admission which was 3/15-3/17/07.  8/14/07 Received hospital medical records which reveal patient experienced nausea 7 vomiting x 5 days.  no stool x 4 days.  Seen by PCP who noted tarry stool & sent to ER.  Fever in ER.  Admitted 3/15-3/17/07.   FINAL DX: Intussusception, enema reduced; acute gastroenteritis.
pt recv vax & devel nausea, dizziness & spasm of muscles;nausea began about 30min p/vax;30min later pt exp an episode of dizziness;pt began to transiently twitch;exp 3 episodes sz-like involuntary movements of head;devel further twitching;
it was like a vagal reaction; gets confused at times; felt nauseous and wanted to vomit; Weaker; Blood pressure dropped; This is a spontaneous report from a contactable Nurse. This Nurse reported for a 90-year-old male patient (husband) that he received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation (90-years at the age of vaccination).  Medical history included ongoing diabetes mellitus Verbatim: Diabetes  Additional Information for Other Conditions: Started 30-40 years ago , ongoing hypertension Verbatim: High Blood Pressure  Additional Information for Other Conditions: Started 30-40 years ago. There were no concomitant medications.  The patient experienced felt nauseous and wanted to vomit, weaker and blood pressure dropped on 10Mar2021, it was like a vagal reaction and gets confused at times on an unspecified date. He received his first Covid shot on 10Mar2021. Reporter states five minutes after the shot the patient said he felt nauseous and wanted to vomit and his blood pressure dropped. Reporter states the patient ended up in the ER. Reporter states that the patient is on hospice at home. Reporter states they took him to the pharmacy for the first vaccine and he has another appointment to go on 31Mar2021. Reporter asks for the number of the pharmacy vaccination site to call to see if they can call and delay the second vaccine The outcome of the events felt nauseous and wanted to vomit, Blood pressure dropped was resolved on 10mar2021, Weaker was resolving and other events was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Got fever on 2nd January morning, fever was there continuously till 3rd January. Fever varies 101.3 to 101.5 degree F Took Tylenol twice a day 12 hrs interval (1000 mg/ dose)  4th January morning onwards there is no fever Still I feel Chills, Fatigue and muscle pain moderately exist.  My PCP (Dr.) and her nurse denied to schedule appointment in person on 01-06-2021
24 hours after receiving my Covid booster shot, I started to get large red itchy blotches on my left back starting near the back of the armpit area to the top of my tailbone. The next day I also noticed both my wrists had the same red itchy blotches.  I took some over the counter antihistamine and used topical hydrocortisone cream.  On day three, the red blotches and itchy skin appear to be clearing up.
10/21 early AM developed new - onset wheezing and fever, followed by seizure with full body convulsions. Parents gave rectal diazepam which halted seizure and went to emergency department. She was stabilized with ALBUTEROL  and sent home on 5d course Prednisolone and home nebulizer.
No adverse events, this is to report a medication error. Patient was to receive MENACTRA vaccine and was given PEDVAXHIB in error. No adverse reaction required.
not feeling so well; did not feel like she had a good balance; discomfort in her left upper arm; Could not walk straight and confidently; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling so well), BALANCE DISORDER (did not feel like she had a good balance), DISCOMFORT (discomfort in her left upper arm) and GAIT DISTURBANCE (Could not walk straight and confidently) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (not feeling so well), BALANCE DISORDER (did not feel like she had a good balance), DISCOMFORT (discomfort in her left upper arm) and GAIT DISTURBANCE (Could not walk straight and confidently). At the time of the report, MALAISE (not feeling so well), BALANCE DISORDER (did not feel like she had a good balance), DISCOMFORT (discomfort in her left upper arm) and GAIT DISTURBANCE (Could not walk straight and confidently) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she is on regular medications and takes 15 pills that she takes every day. Treatment medication information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received contains no new information.
No adverse events, only out come was elevated BNP levels detected during blood test for life insurance test
Tightness and soreness in left armpit; A tendon or something inmy armpit is very hard now and tenderto the touch.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 16Mar2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included genetically high cholesterol. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) 40 mg from an unknown date for genetically high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 08:00, the patient experienced tightness and soreness in left armpit the shot was administered in left arm. A tendon or something in armpit was very hard and tender to the touch. It was like a hard string inside armpit, and was noticeably different from right armpit. Patient reported that it had been 4 weeks since that shot and it was still present, had second dose in right arm, and the reaction didn't occur there. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tightness and soreness in left armpit, a tendon or something in armpit was very hard and tender to the touch. It was like a hard string inside armpit was not recovered.  No follow-up attempts are needed. No further information is expected.
Pinpoint papular rash on back from one axillary line to the other, between T4 & L1 and on right arm between mid-humerus and mid-forearm. Rare lesions on legs. No pustules or vesicles or itching. Too early to tell if recovered.
PT DID NOT HAVE ADVERSE REATION TO VACCINES.  THEY WERE ADMINISTERED AT 45 DAY INTERVAL INSTEAD OF 60 DAYS.  PT RECEIVED PPSV23 AND SHINGRIX #2 ON 1/7/2020, FOLLOWING PCV13 AND SHINGRIX #1 ON 11/26/19.     PCV13-PPSV23 INTERVAL WAS SHORTER THAN RECOMMENDED, BUT OK SINCE PT TOLERATED.   WILL NEED PPSV23 IN 5 YEARS.   SHINGRIX #1-2 INTERVAL WAS ALSO SHORTER THAN RECOMMENDED.  CONSIDER "VALID DOSE" AROUND MONTH 6 (MAY 2020).
patient has received expired dose of vaccine/ NO AE; Initial information received on 12-Jul-2021 regarding an unsolicited valid non-serious case received from other health professional via Medical information (MI) number 00678839.  This case involves 11 years old male patient who administered an expired dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  On 06-Jul-2021, the patient received a dose first 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) Suspension for injection (strength: standard, Frequency: once, lot number U6378AA and expiry date: 04-Jul-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was reported that ''the caller would like to know whether the dose should be repeated''.   It was a case of an actual medication error due to expired vaccine used (latency: same day).  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 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.
Brief syncope immediately at administration of HPV vaccine.  Recovered immediately, observed for extended period of time and recovered fully back to baseline.
DIVOT ON SKIN LIKE A HOLE; INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced divot on skin like a hole, and infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the divot on skin like a hole and infection was not reported. This report was non-serious.
Pt recvd vax on 14MAR91 & ON 31SEP92 lab eval revealed a low Hep B surface antibody titer of 20.8ru; No further details were provided;
Information has been received from concerning a 9 year old male who on  09/07/1992 was vaccinated. On 03/24/2001, the pt developed chicken  pox and a fever with more than 70 lesions. The pt sought unspecified medical attention. Additional information has been requested.
2 Days after vaccine administration, I developed severe tinnitus and ringing in bilateral ears, sound sensitivity and pain. I have suffered from severe headaches. Completed 2 courses of an oral steroids with no improvement.( 1 in April and 1 in June I have seen multiple ENTs, Neurologists, dentists, physical therapists and have had many diagnostic tests with no symptom improvement or other causative diagnosis. Symptoms persist with no change since onset on 3/18/22
This spontaneous report was received from the a healthcare worker (the patient's mother) referring to a 2 months old male patient. The patient had no concomitant medication, pertinent medical history and drug reactions or allergies. In October 2016 (also reported as when the patient was 2 months old), the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacture unknown), poliovirus vaccine inactivated (unspecified)and diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (DTaP) (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. In approximately 2016 (also reported as in less than a week post vaccination) the patient experienced seizure and the patient's mother also reported the patient was taken to see a naturalist for a heavy metal detox which he went through 4 sessions to rid his system of heavy metals. Unspecified bloodwork was collected to determine that patient was heavy metal free. Treatment was given for the adverse events. The outcome of seizure and metal poisoning was reported as recovered. The causality assessment was not provided by the reporter. Upon internal review, the events seizure and metal poisoning were determined to be medically significant.
Right leg DVT, bilateral pulmonary emboli, left ventricular apical thrombus