chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fell out completely; passed out/fell off at the store; feeling dizzy; had terrible headache; chills; weak with shilling; i started sweating; I'm still feeling very sick; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158; Expiration Date: Jul2021), via an unspecified route of administration, administered in left arm on 14Apr2021 12:00 as single dose for COVID-19 immunisation. Medical history included eye allergy. Concomitant medication included amoxicillin sodium, clavulanate potassium (AMOXICILINA CLAV) taken for eye allergy from 12Apr2021. On 14Apr2021, he received the first dose of the vaccine about an hour ago and waited five minutes and went to the bathroom. He had a severe reaction while patient was in the bathroom, he started to feel dizzy, had a terrible headache and chills. He walked out of the bathroom at the store and fell out completely in front of the pharmacists. The patient also experienced weak with shilling (as reported) and started sweating. The pharmacists called 911 and the responders checked his vitals and blood pressure and all of that and everything was fine. Patient clarified he passed out completely for almost 5 minutes. Patient stayed there with everyone until, they were waiting to see how he was doing. He reported he was feeling much better now, still feel a bit dizzy, not 100% but not as bad as when it happened. It has improved and he definitely felt terrible at the time. He was monitoring himself at home to see if he notices something weird going on. He does not have a headache right now and was feeling much better. When he was having the effect, he was mentally sharp, and knew what was going on. He thought about letting himself walk outside the bathroom so he could be seen. He didn't lose track of what was going on and body reacted adversely. He remembered stuff and everything and he felt good. Patient stated the chills went away; however, would not say they went away completely, he was recovering. The events did not require a visit to emergency room or physician office and the paramedic said it was not necessary right now because all the vitals and everything else seemed fine. There was no therapy received for the events. There were no additional vaccines administered on same date of the vaccine and no other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events feeling dizzy, terrible headache, chills was recovering; still feeling very sick was unknown; outcome of the rest of events was not recovered.
RIGHT AFTER THE SHOT, THE PATIENT SAID THAT SHE FELT LIGHT HEADED AND TIRED. SHE STARTED TO SHAKE AND SLUMPED OVER AGAINST HER FATHER THAT WAS NEXT TO HER. SHE STARTED TO SNORE, WOKE UP AND THEN PASSED OUT AGAIN. HER FATHER SAID THAT SHE REACTS TO SHOTS THIS WAY. SHE DID NOT RECEIVE ANY TREATMENT. SHE WAS IN THE PHARMACY FOR A TOTAL OF 25 MINUTES.
From initial information received on 2/12/03 it was reported that a male patient reported swelling in arm and can't move their arm. Previous booster dose not known at this time. Patient scheduled to see doctor later for assessment. Additional information has been requested from the reporter.
Pt called on 8/10 reporting that her arm was red, warm, swollen & tender with a knot
Extreme pain in arm of injection radiating up the neck and down to finger tips, swollen, weakness, hot, and red arm.  Fever and nausea.
Pt developed fever off and on for a week post vax. She also developed a knot in her leg.
Extreme flare up of chronic neuropathic pain in all four extremities, felt like my legs were going to collapse, extreme flare up of carpel tunnel syndrome in both hands, could not use my hands for activities of daily living. Very, very painful.  I have underlying chronic peripheral neuropathy in all four extremities.  Becomes  much, much worse with influenza vaccine and medications.  Maybe I am just too sensitive to vaccines??? My new neurologist, Dr., says I'm too sensitive to medications and vaccines.  But I really need to take them to prevent a fatality.  I am 67 years old.
Episode of Transient Global Amnesia. Event lasted about 12 hours and then resolved itself.
Flu vaccine administered on 12/11/03.  On 12/14/03 grandmother states the pt broke out in hives.  She was advised to administer Benadryl every 6 hours which seems to have helped with the hives.
significant headache, chills, fatigue, very sore arm.  Took Tylenol at 3:00am, 7:00am, 1:00pm, 4:00pm.  Chills stopped after about 4 hours.  Headache ended about 24 hours later.  Arm soreness reduced by 50% the following day, but still very tender.
9/28 symptomatic COVID breakthrough.   Inpatient admit 10/2/21
My glucose dropped to dangerous lows. I lost consciousness and my husband had to call 911.  Paramedics revived me with glucagon.
she has been having allergies; but has been having a stuffy nose, runny nose, sneezing,; but has been having a stuffy nose, runny nose, sneezing; but has been having a stuffy nose, runny nose, sneezing; a little bit of a sore throat; feeling ill; This is a spontaneous report received from a non contactable consumer(Patient). A female patient of an unknown age received first dose of BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date not reported), via unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she has been having allergies and did a COVID rapid test today and was negative. She states she feels better, but has been having a stuffy nose, runny nose, sneezing, and a little bit of a sore throat. She is due for her second dose of Pfizer's COVID vaccine for Thursday, 29Apr2021. She asked if she should receive the second dose if she is feeling ill.  Response: Provided disclaimer that Pfizer is unable to make recommendations for individual patients and referred caller to HCP.  No follow-up attempts are possible. No further information is expected.
pt recvd 1 dose of Engerix-B vax on 2JUN92 & exp flu-like sx, pseudomonas bronchitis; hospitalized from 11JUN - 19JUN92; p/exp hemoptysis;
Sharp pain during injection, slight soreness at site. That evening woke up with dull pain all down Lft arm from shoulder to hand, especially in deltoid region. 2+ months later still have range of motion issues (deltoid) better - but still there.
Diarrhea, start 4/6/2021 at 10pm stop: 04/07/2021 at 12AM Fatigue start: 04/07/2021 at 09AM; stop: 04/07/2021 at 2PM
experienced rapid heart beat, severe chills and muscle aches, and fever with no response from tylenol. Then, went to ER, had fever of 102.7 (after taking tylenol), tachycardia, and thrombocytopenia.  Was discharged home after 2 liters of IV fluid and tylenol, and followed up with PCP 10 days later with repeated lab work that showed thrombocytopenia had resolved. EKG normalized. tachycardia resolved.  5 weeks later had a new onset of pain and swelling to right ankle- no injuries. Diagnosed with gout on 10/19/21.
no adverse effects; Temperature excursion; This spontaneous report was received from physician referring to a 3-month-old (also reported as 4 months, conflict information) male patient. The patient's historical vaccine included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) on 15-FEB-2023 and 18-APR-2023 (basic series and booster series, respectively), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (basic series) on 18-APR-2023, pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (basic series) on 18-APR-2023 and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (basic series) on 18-APR-2023. Concomitant medications included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (booster series) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (booster series). The patient's concurrent condition was not reported.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion, and the vaccine was not viable according to manufacture. On 12-JUN-2023, the patient was vaccinated with the second dose of (booster series) improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968385, expiration date: 22-MAY-2024, administered orally (PO) by a physician in private doctor's office/hospital for prophylaxis (strength and dose were not provided) (product storage error). The vaccine was purchased with private funds. Alarm believed to be due to sensory issues, and temperatures were monitored with back up logger. Temperature was in range, new data logger was currently in use. No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
12:30 PM - 30 MINUTES AFTER RECEIVING THE SECOND DOSE OF MODERNA VACCINE ITCHING AND BURNING SENSATION BEGAN IN HER LIPS AND IN THE FOREHEAD BETWEEN EYEBROWS. iT INCREASED THROUGH THE DAY AND SWELLING OF LIPS WAS PAINFUL ON THE NEXT DAY 4/20. aLL IMPROVED ON THE MORNING OF 4/21. PATIENT TOOK PICTURES.  SHE SELFMEDICATEDWITH ICE AND  ALTERNATING ORAL ACETAMINOPHEN AND NAPROXEN EVERY 4 HOURS ON 4/19 AND 4/20. HISTORY OF COSMETIC TREATMENT WITH BOTOX AND LIP ENHANCEMENT FILLER (RETILANE) ON 3/23/2021 IN CLINIC
Overall fever from 1:00am on 04/17/21 through 6:00pm on 04/17/21 (17 hours) High fever of 102+ from 2:30am on 04/17/21 through 4:30pm on 04/17/21 (12 hours) Treated with ice packs applied to head, chest, stomach as well as extra-strength Tylenol Chest pain/trouble breathing/coughing that is slowly subsiding since early morning 04/17/21 through present Consistent shaking from 2:00am on 04/17/21 through 6:00am on 04/17/21 proceeded by intermittent shaking through 04/17/21 Cramps, loss of appetite, back pain, sudden sharp pains for no apparent reason, nausea, dizziness, and headache for 24 hours
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursions. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
p/vax pt c/o feeling very tired/exhausted. next day began vomiting & was unable to keep down solids. stomach felt very queasy & sour lasting 2-3 days.
The patient describes that for 3 days following the vaccination they had red swelling and heat in the spot that they were vaccinated. After the swelling and heat went away, they had bruising at the site for 3 additional days.
Information has been received from a physician concerning a 6 year old male who on 3/29/2000 (at 13 months of age) was vaccinated subcutaneously with a one time 0.5ml first dose of varicella virus vaccine live. On 5/12/2005 the patient came to the physicians office with a classic case of chickenpox. He had 100 vesicular lesions all over his body, including on the truck, scalp, face, neck and extremities. Some of the lesions were crusted over. It was reported that the patient recovered (date unspecified). No product quality complaint was involved. Additional information is not expect.
No concerns following the vaccine, however 7-8 days after administration started itching and noticed a large raised reddened area, warm to the touch.
Pt was fine came for physical determined she needed HPV shot #1. No Hx of GBS or allergies or seizures. Gave shot IM rt deltoid within 5 minutes she fell back on exam table and had 30 second seizure and then was alert again. Sent to ER for further evaluation.
On 03/29/01 father of child returned with patient for trouble breathing. He reported to a nurse that on 03/28/01 approximately 1:00 AM, the child began with seizures and the EMS was called. Transported to the ER released later. Give Motrin and Tylenol, and see PCP. The PCP was seen later that day with same treatment for the fever. On 03/30/01, child report having fever of 101, treatment being followed. On 04/02/01 the child was afebrile, no other symptoms reported.
Became pale, diaphoretic and anxious during post vaccination observation period. Vital signs within normal limits, cool compress to neck. forehead & color returned to face. Observed > 30 minutes with no further issue. No additional health care services provided.
My husband got that illness and he got two vaccines /suspected vaccination failure; My husband got that shingles illness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: My husband got that illness and he got two vaccines /suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My husband got that shingles illness). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2023 This case was reported by a patient's wife via interactive digital media. The reporter reported that the patient experienced that shingles illness and he received two shingles vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Hot itchy lightly bumpy rash started on cheeks, daily progressed to head, neck, chest , abdomen and back, arms and legs x?s 2 weekFace swollen twice size 4/29/21 in am, swelling slowly increased to whole body x?s 2 weeks.  OTC Benadryl, cold compresses, baking soda bath Course of Prednisone 60 mg x?s 2 days, 40 mg x?s 2 days, 30 mg x?s 2 days, 20 mg x?s 2 days, 10 mg x?s 2 days, 5 mg x?s 2 days.  Some improvement, second course of Prednisone  20 mg x?s 5 days Swelling face, upper arms and abdomen continue, rash on cheeks continue., whole body itching continues.
PATIENT PRESENTED:  -DIAPHORESIS -PALLORNESS -NAUSEA -DIZZINESS TREATMENT: 02 NASAL CANULA  RAISED LOWER EXTREMETIES OBSERVATION FOR 30 MINUTES THEN DISCHARGED
Severe pain, swelling in arm that kept me awake most of Friday night requiring Motrin x 2 doses and ice to area and still continued into Sunday. I had fever, headache, chills, muscle and joint pain, extreme fatigue and slept for hours all day Saturday, Sunday into Monday, which I called off work. I felt as if I had the virus all over again , except this time it felt much worse. I am worried to get the second vaccine as it states it is worse than the first. Would like and appreciate any feedback on this.
Information has been received from a nurse concerning a 15 year old female who was intramuscularly vaccinated with a dose of GARDASIL (MSD) on 04-FEB-2208. Concomitant vaccination on 04-SEP-2008 included MENACTRA (manufacture unspecified) in the same arm at the same time. Approximately on 19-SEP-2008 ("about 3 days ago") the patient experienced blisters around the injection site after she received GARDASIL (MSD) and MENACTRA (manufacture unspecified). On 22-Sep-2008, the patient was schedule to come into the physician's office for a check-up. The patient was recovering at the time of report. No further adverse event information reported. The patient called the doctor to seek medical attention. Additional information has been requested.
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the group along with Moderna. Treatment details was not reported by the reporter. This case contains information about 18th patient out of 25 patients.  Company comment: This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (death/medically significant) event of neoplasm malignant. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Headache, Myalgia, fatigue Narrative:  diagnosed with covid in September 2020
Took one dose of Vivotif while taking minocycline daily; Spontaneous report received on 07JAN2020.  A nurse reported that an adult female (age in between 20-30 years) consumer "took one dose of Vivotif while taking minocycline daily" (PT: Labelled drug-drug interaction medication error). He was receiving Vivotif for immunisation and minocycline for acne. The consumer took first dose of Vivotif on 06JAN2020. She was also taking minocycline daily before starting Vivotif for acne. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif
This spontaneous report was received from a physician refers to a 18 year old male patient. No medical history was reported. The patient was vaccinated with dose 1 M-M-R II(lot #,expiry not reported) on 19-FEB-1996 and with dose 2 of M-M-R II (lot #,expiry not reported) on 31-MAR-2000, 0.5 ml, subcutaneously. No concomitant medications were reported. The physician reported that the patient who had received 2 doses of M-M-R II in the past and now (on an unknown date 2013) has an equivocal titer result (1.04) for mumps. The outcome of equivocal titer result (1.04) for mumps was unknown. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Patient was given MMR-V even though they were on hydroxyurea for sickle cell. Hematologist was notified of the potential contraindication. Hydroxyurea was not discontinued and patient's mother was told to inform them if any fever occurred.
Patient was reported to be nervous prior to vaccine. After vaccine during 15 minute waiting period. Patient went to restroom. Reported vomiting and passing out briefly for a minute. EMS was called and vitals were taken. No epinephrine was administered
Gout in my ankle; This case was reported by a consumer via interactive digital media and described the occurrence of gout in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th January 2022, the patient received the 2nd dose of Shingles vaccine. On 28th January 2022, 4 hrs after receiving Shingles vaccine, the patient experienced gout. On an unknown date, the outcome of the gout was unknown.   It was unknown if the reporter considered the gout to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received second dose of Shingles vaccine and 4 hours later experienced gout in ankle. Consent to follow up was not possible as no contact details were available.
As soon as the injection began on Day 1, I had pain at the site.  Later that day, the pain got worse and the site was red, swollen & hot. Day 2- I woke up with a bad headache, muscle & joint pain, and fatigue. I felt like I had the flu. Injection site red, swollen & hot. Day 3- Headache, aches, injection site red, swollen & hot. Day 4- Headache.  Injection site red, swollen & hot. Day 5- Injection site red, swollen & hot. Day 6-  Injection site red, swollen & hot. Hives on my upper left arm. Day 7-  Injection site red, swollen & hot. Hives now spreading down arm. Day 8- Injection site red & swollen. Hives on left arm. Day 9-Injection site red. Hives begin to fade. Day 10- Outline of hive clusters, redness fades.
Patient presented for update 16 y/o vaccines.  Pt. due for men ACYW, men B, HPV #2.  Nurse thought I said "Hep B," and thus patient got hep B vaccine unintentionally.  No adverse reactions, patient has received the Hep B vaccine before without any adverse issues.  Patient's parent contacted and informed.  Staff person contacted & informed.  Internal incident report completed.
At about 11:54 am the patient fainted after receiving vaccines. The patient was transferred to the bed and legs were elevated. Vital signs were done and the MD was called. The patient was monitored or about 20 minutes and given reassurance. After about 30 min. the patient was ambulating without any signs of distress.