chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant concerning a 27 year old female patient with Crohn's disease and an allergy to sulfa who several years ago was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy included mercaptopurine, mesalamine, Nefazodone HCl and ethinyl estradiol/norethindrone acetate. It was reported on 06JUN2003 that laboratory evaluation revealed that the patient's titer drawn in the past month is low. Unspecified medical attention was sought. Additional information has been requested.
I had the first injection on 12/1/2011. That day my arm was very swollen and the injection site was very sore. The swelling and pain lasted ~7 days and then went down. I thought all was well until two weeks later when the swelling and pain came back (lump around injection site). I started to have severe dizziness and neurological twitching. I ended up in the urgent care, and have had just under $3,000 dollars in medical bills trying to figure out what has been going on (brain MRI's, blood tests, other various tests and images). It has been a true financial struggle.  After how much this has cost me (as I have a high deductible), I absolutely refuse to get the second shot. This should be taken off the market.
headache, NauseaVomiting, Chills, body aches (unspecified) Narrative:
101,Fever after 8 hours of receiving the vaccine, nausea fist  few hours. fever lasted for 24 Hours.  Heavy period  started  60 hours after receiving second dose.
Patient received shingles booster shot on 8/6/2019.   (She received first shot on 5/21/2019).  She later developed severe itching at the injection site.  On Thursday, 8/8/2019 she developed a pustular rash on her arm along her elbow area that was hive like.  She also developed one hive on her leg.  She self treated with Benadryl and washed the area with a special soap that she said is used for Poison Ivy.  She has had shingles in the past and said the rash closely resembled the rash she had at that time.  She still had the rash on 8/14/19 when she reported the incident to me, but it is improving.  Oddly enough, she has also developed a cold sore on her lip.
Pt dad noticed onset of fever on 04/15 to be around 102-103 degrees that evening. Started treating with Childrens Tylenol and ibuprofen, cool baths, increased fluids. Fever spiked 04/17 at 104.4 degrees, slight rash on chest, waist, legs, noted per father. Continued above treatment. 04/18/05-5:00 fever 103.8 by 10:00 98.8 while on phone at 2:00 dad mentioned pt to be "chilled" again. Recommeded  to continue treatments and notify MD if not better by 04/19. Father denies any breathing difficulties or seizure activity, only "sillyness" when fever spiked.
A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine).    No concomitant medication information was reported. It was reported that a patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine. IE (They never received the any of the two primary doses). The HCP confirmed that a patient received a bivalent booster dose as their first COVID19 vaccine. The HCP wanted to know what to do next. The HCP declined to provide any patient information. No treatment medication information was reported.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. Concomitant product use was not provided by the reporter.
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest.  Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM.    911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
loss of smell; Loss of taste; feeling like a sinus infection; pain at the injection site; muscle pain; Headache; Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, expiration date: Nov2021), via an unspecified route of administration on 11Jan2021 at 11:00 AM in the left deltoid at single dose for work as behavioral technician. Medical history included Chronic headaches predates his treatment with bnt162b2. Family Medical History was none. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Patient reported he got the first dose of the bnt162b2 on 11Jan2021. He noticed one and a half hours later (12:30) pain at the injection site and muscle pain; then 12Jan2021, the next day lost his sense of smell and taste and it felt like a sinus infection. Added he didn't know exactly what a sinus infection felt like but he felt like he had jumped into a pool without holding his nose. Added twelve later (on 12Jan2021) the muscle pain resolved; his injection site was still a little painful and he still couldn't smell or taste. He was planning to get the second dose of the vaccine on 03Feb2021. Added he took ibuprofen for a headache later the night of the vaccine 11Jan2021. He had headache multiple times a week. This headache started that day. After taking the ibuprofen his headache resolved that same day. There were not any events require a visit to physician or ER. Therapeutic measures were taken as a result of events headache. No investigation assessment. The outcome of the event headache was recovered on 11Jan2021, muscle pain was recovered on 12Jan2021; outcome of events pain at the injection site and feeling like a sinus infection was recovering; outcome of the other events was not recovered.
Information has been received from a health professional concerning a female who was vaccinated on an unspecified date with a dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently on an unspecified date the patient experienced pain at the injection site and swelling of the arm. The patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
I had a headache and started having stomach cramps and pain in my side. Then on the 5th I had bloody stool. I called the Dr. and emailed them and they called me back on Monday. They gave me an appointment with my PCP and she had me go to the hospital and they did a CT scan with a drink and an injection. They determined I had Colitis. I am taking Ciprofloxacin a this time. I am still dealing with this at this time.
Severe muscle aches throughout body, recurring headache, upset GI. Resolved approximately 3 days after injection.
After 12 hours I had a fever, chills, body aches and head ache After 24 hours I had a fever, head ache and left are hurt
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 OF 09Jan90 PT EXP SIMILAR PAIN AT SOI.
Fever, sleeplessness, tiredness, headache declining after the first 24 hours.
Patient reported feeling hot, having headache and feeling "funny".  I monitored patient's temperature and Blood Pressure. Patient applied cold compress. Patient's blood pressure dropped from 144/103  to 133/97.  Patient stated she did not need medical attention and left with her boyfriend.
#2 dose 3 hr. after GARDASIL - rash on torso. Lips & hands swelled. Hands painful. BENADRYL OTC for 4 days q 6hr. 1st dose hands swelled - painful.
Information has been received from a registered nurse concerning a 14 week patient with a history of premature infant who on 26-NOV-2008 was vaccinated with the first dose of ROTATEQ.  No adverse effect reported.  The patient's outcomes were unknown.  It was unspecified if the patient sought medical attention.  Additional information has been requested.  Follow up information was received from the registered nurse to report that the patient also vaccinated with a dose of MMR on 26-NOV-2008.  Additional infromation has been received on 06-JAN-2009 from Registered Nurse concerning a 14 weeks male with Grade III intraventricular hemorrhage neonatal and a history of premature birth at 23 6/7 weeks, pneumonia and neonatal respiratory distress syndrome. The infant was hospitalized from birth due to premature birth while in the hospital infant received the following vaccinations on 13-OCT-2008: PEDIARIX, PREVENAR and HIB (manufacturer unknown) (the date of discharge was not reported). On 19-NOV-2008, the infant received SYNAGIS in the physician's office. On 26-NOV-2008., the infant received ROTATEQ (Lot # 661685/0967X) at 12:35 PM.  Additional infromation is not exepected.
Cl. in for 3rd Rabies Vaccine. C/O swelling at injection site and c/o both knees swelling the day after the 2nd shot. "Feeling achy all over".
*8/22/2023 Patient contacted this office and reported on 9/7/2022 after vaccine he experienced bilateral facial twitching near his eyes.  Reports this resolved within 48 hours.  He also reported after receiving vaccine he went to a drive thru for lunch and while eating had bilateral inner ear pain and jaw pain while eating. Reports this resolved after 72 hours. Patient did not contact this office regarding these symptoms until 8/22/2023. *Patient reports on 9/18/2023 he picked up a rock and had Left arm retinaculum pain and swelling. Reports this resolved after 1 week.  *10/20/2022 Patient reports he experienced spontaneous bi-cep detachment from radius of the Left arm which he had repaired 2/2023. States he had to delay surgery due to work responsibilities. He reports he had outpatient surgery at Surgery Center. Patient reports that he believes the above events could be a possible vaccine injury. Informed patient that this nurse would complete a report and suggested he do the same. Patient states he is familiar with reporting system.  Regarding question 20 and 21 below, completed the question regarding same day facial twitching and inner ear/ jaw pain. Since the vaccine was given on the Right arm on 9/7/2022, I did not know if the injuries he reported regarding the Left arm applied to the questions.
Urticaria (rash all over upper body, front and back, arms, thighs, buttocks).  Rash onset 8/15, worsened 8/16, on 8/17 took Allegra and used Witch Hazel.  Symptoms started to abate 8/18 and were gone by 8/19.
No further information provided./No other AE.; The customer administered GARDASIL 9 to a 7 month old patient on 1/6/2021; The nurse inadvertantly brought the wrong vaccine; Product dispensing error; This spontaneous report has been received from a registered nurse, concerning a 7 month old female patient. None pre-existing physician diagnosed allergies, birth defects, or medical conditions were reported. None concomitant medications were reported.   On 06-JAN-2021, the nurse inadvertently brought the wrong vaccine, for a dispensing error into the patient's room and administered it to the patient. It was reported that the patient was waiting for long than usual , therefore she was trying to be quick and pulled the vaccine. The patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T008101, expiration date of 01-MAY-2022 (reported as 01-MAY-2021), intramuscular (IM), in her thigh for prophylaxis. (inappropriate age, wrong product administered, product dispensing error). The nurse realized the error when she returned to the nurse's lab. The patient was asked to stay for observation, and this situation was reported immediately to the doctor, the company and the poison and infectious disease center. No adverse effects were observed or reported later.    None illness at the time of vaccination were reported. The patient was vaccinated at the private doctor's office/hospital with private funds. No temperature excursion occurred as a result of a reading from a Digital Data Logger.  It has been determined that case # US-009507513-2101USA003619, is a duplicate of case #US-009507513-2101USA004510. Therefore, case # US-009507513-2101USA004510 is being deleted from our files and the case are consolidated into case # US-009507513-2101USA003619. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008101; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Administration site reaction.  2 inch raised welt, red, warm to the touch, painful.  Began 12-18 hours after vaccination, slowly resolved on its own over the course of 2 weeks.
Severe pain at injection site, subsided in 3 days. 101 degree fever subsided 2 days after taking Excedrin. Chills, muscle aches and arthritis inflammation. Migraine headache. Took Excedrine 36 hours after injection. Most symptoms eased up after a week.  However,  migraines increased to 3 to 4 a week, with blurry vision, light flashes and vertigo. They have become less frequent but am still having one or two per week. They have Never been this frequent and I have never experienced vertigo with them.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with unknown number of doses of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneous (lot # was not reported). No adverse effects were reported. Additional information has been requested.
Nausea; vomitting; Unwell feeling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 03:15 (Lot number: Fk5618) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 06Dec2021 07:00, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 06Dec2021 07:00, outcome "unknown", described as "vomitting"; MALAISE (non-serious) with onset 06Dec2021 07:00, outcome "unknown", described as "Unwell feeling". Therapeutic measures were not taken as a result of nausea, vomiting, malaise.  Additional Information: There was no Seriousness criteria for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, and Congenital anomaly/birth defect. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. There was no Prolonged hospitalization. No Relevant past drug history. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
the patient complained of face tingling and sensation of tongue swelling a few minutes after receiving vaccine.  Her tongue did not appear swollen, she had  no shortness of breath.  Her symptoms resolved after an additional 30 minutes of observation and she was discharged to home.  She did not require medical intervention.
Body aches; Nose bleed; Weak; Muscle aches; Chills (no fever); Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8729) via an unspecified route on 12Apr2021 at 17:30 in the left arm (at an age of 58-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included hypothyroidism. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient received other vaccination within 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8727) via an unspecified route on 22Mar2021 in the left arm as single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 03:00, the patient experienced headache, chills (no fever), body/muscle aches, weak and nose bleed. Therapeutic measures were not taken as a result of the event. The event 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 of headache, chills (no fever), body/muscle aches, weak and nose bleed was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
her arm got really really sore for several days up into her shoulder; her arm got really really sore for several days up into her shoulder; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 80, no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. The patient has a lot of unspecified underlying conditions. The patient had a flu shot on an unknown date and she stated even with the regular flu shot it makes her arm sore at the site every time. The patient was on unspecified blood thinners. On an unspecified date, her arm got really really sore for several days up into her shoulder. Investigation assessment was not provided. The outcome of the events was unknown.   Information on the batch/lot number was requested.
Minor allergic reaction. Mouth lips and tounge tingling and feeling weird  similar to nut allergy reactions. Bumps on lips. Started about 20minutes after and went away after an hour and came and went though the rest of the day.
expired dose of Daptacel was given to a patient; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from an-other healthcare professional by phone.  This case involves a 24 months old female patient who was vaccinated with an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5101AA and expiry date: 26-Nov-2018) via intramuscular route in the right thigh on 05-Apr-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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 the sender: none.
Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19 Vaccine; Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH6964) at the age of 72 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK9231), on 01Feb2021 as dose 2, single (Lot number: EL9262), on 29Aug2021 as dose 3 (booster), single (Lot number: EW0185) and on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma. Concomitant medication(s) included: FINASTERIDE (ongoing); TAMSULOSIN (ongoing); QVAR taken for asthma (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "not recovered" and all described as "Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive, notes: Unit: Not Provided. Tested positive for Covid 19 on a self test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Follow-up attempts are completed. No further information is expected.
Itchy red rash entire left deltoid area, has lasted more than 2 weeks so far and entire right ear is itchy swollen and red--ongoing
Dizziness, NauseaVomiting, severe vertigo, vomiting and diarrhea, weakness Narrative:  dizziness started approx 2 hours after vaccine was administered. that evening, experienced severe vertigo and weakness, vomiting and diarrhea and collapsed on the bathroom floor. took some benadryl. next day could not get out of bed due to dizziness and weakness. have since recovered.