chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a headache within two hours after the shot, and it lasted for the rest of the day; woke up from severe body aches and shivers/I was in 9/10 pain from body aches; woke up from severe body aches and shivers; I was sweating, feeling like I had a fever; next day I woke up very tired and fatigued and I was unable to leave my bed; My arm at the injection site became very inflamed, swollen and painful; My arm at the injection site became very inflamed, swollen and painful; My arm at the injection site became very inflamed, swollen and painful; This is a spontaneous report from a contactable consumer. A 32-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 10:45 (Lot Number: 5318, Expiry date: Unknown) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included heart rate increased, oral surgery. Patient did not have COVID prior vaccination. Concomitant medication(s) included ZYRTEC [CETIRIZINE HYDROCHLORIDE] and metoprolol. The patient previously took first dose of bnt162b2 for COVID-19 immunisation, morphine and experienced hives. There were no other vaccines taken in four weeks. On 17Feb2021 01:00 PM patient experienced headache within two hours after the shot, and it lasted for the rest of the day, woke up from severe body aches and shivers/she was in 9/10 pain from body aches, woke up from severe body aches and shivers, she was sweating, feeling like she had a fever, next day she woke up very tired and fatigued and she was unable to leave my bed and her arm at the injection site became very inflamed, swollen and painful. At 2am, she woke up from severe body aches and shivers, and it did not pass for 2 hours, at which point she took 600 mg Ibuprofen. The pain relievers worked within 20 minutes and she was able to sleep. Body aches lasted Thursday and Friday, and she still feel fatigued to this day. The injection site is not as red anymore and does not hurt, but it is still swollen and feels very hard to the touch almost a week after the shot. The patient underwent lab tests and procedures on 18Feb2021 which included body temperature: 98.5f and pain assessment 9/10. Patient did not test covid post vaccination. Therapeutic measures were taken for the event severe body aches and shivers with 600 mg Ibuprofen. Rest of the events didn't receive treatment. The outcome of all events was recovering.
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 16-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N024566 with expiration date 07-SEP-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of VARIVAX was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001201: US-009507513-1805USA010447.
pt recvd vax 2JUL95 & 8JUL95 or 14JUL95 pt devel 10 to 15 generalized chicken pox type lesions all over body, mild fever & itching sites along trunk, arms, & legs;
Lethargic after 07/11/2001 immunizations. Had grand mal seizure 07/13/2001 with fever afterwards.  Hospitalized with multiple tests.  One year shots on 01/02/2002.  Grand mal 01/03/2002 and they haven't stopped since. The discharge summary received on 12/31/03 confims the diagnosis of seizures. Seizures still occur on a regular basis. Information from Annual Follow-up report states seizures continue; however they are getting less frequent. Instead of once a week they have been once every couple of months. I think it is "malpractice" that doctors will not admit that adverse reactions take place due to vaccinations.
Information has been received from a licensed practical nurse concerning a 13 year old female who on 03-AUG-2007 was vaccinated with a dose of GARDASIL (lot # 653735/0688F). On 04-AUG-2007 the patient developed nausea and fever. The patient sought unspecified medical attention. The patient recovered from nausea and fever on an unspecified date. Additional information has been requested.
12 hours after injection: 12 hours after injection and then resolved the next day: drenching night sweats severe joint pain especially in hips and knees - even ribs hurt passed out and disoriented significant contracture of bilateral upper extremities from elbow to hands when I could not open them for over an hour rt ear tinnitus numbness in hands and feet tiredness
No known adverse effects; an administered dose of VAQTA underwent a temperature excursion on 02/19/2020 prior to being administered to 1 patient on 02/20/2020; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.     On 19-FEB-2020, an administered dose of hepatitis A vaccine, inactivated (VAQTA) underwent a temperature excursion prior to being administered. On 20-FEB-2020, the patient was vaccinated with the dose of hepatitis A vaccine, inactivated (VAQTA) (lot number S025993, expiration date 17-OCT-2020; route, strength and frequency unknown) for prophylaxis (incorrect product storage).  The storage temperature of the vaccine was 10 degree Celsius for a time frame of 2 minutes. There was no previous temperature excursion. The call was because of a data logger. No known adverse effects were reported.
numbness in left side; pins and needles in left hand and back of left shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955; Expiration Date: 30Jun2021) via unspecified route single dose for COVID-19 immunization on 31Mar2021, at 58-year-old. The patient medical history was not reported. The patient's concomitant medications were not reported. In the last couple of days (Apr2021), she had been getting numbness in her left side. She reported this could be due to other medical issues. The patient described tingling that felt like pins and needles in her hand, only in her left hand, and a little bit in the back of her shoulder, behind edge of left shoulder. She ran her hand under warm water to try to make it go away.  She explained it's almost as if she slept on her arm and it was asleep. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
Information has been received from a physician concerning a 50 year old white female employee with no known allergies or past medical history who on 25-JUN-2006 was vaccinated in the left deltoid with a first dose of Varivax. There was no illness at the time of vaccination. Subsequently the patient developed 3-4 vesicular lesions at the injection site. At the time of the report the lesions persisted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information received from the physician indicated that the patient recovered on 29-JUN-2006. No additional information is expected.
approx 3yrs p/vax pt exp chickenpox. MD ofc rpt mild case w/30-50 pustules, mostly on the face & upper  back & chest
very fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (very fast heartbeat) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEART RATE ABNORMAL (very fast heartbeat). At the time of the report, HEART RATE ABNORMAL (very fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included thyroid pills and pressure pills. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.  Elderly age along with underlying condition may have been contributory.
patient fell and has been in rehab; unable to get their 2nd dose within the 42 day window; This spontaneous case was reported by a nurse and describes the occurrence of FALL (patient fell and has been in rehab) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (patient fell and has been in rehab) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window). At the time of the report, FALL (patient fell and has been in rehab) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant information were provided by the reporter.
PATIENT BEGAN EXPERIENCING PAIN IN THE LEFT ARM, SHOULDER AND NECK ABOUT 2 WEEKS AFTER THE IMMUNIZATION. STATES THAT SHE IS HAVING DIFFICULTY RAISING THE ARM.  UNSURE IF RELATED TO THE IMMUNIZATION. ADVISED PATIENT TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN.
pt recv vax 23AUG95 & 3JAN96 pt devel typical varicella lesions;4JAN96 presented to a MD ofc w/chickenpox over entire body;approx 50 lesions;
Prevnar given 1/14/02. Within 24 hrs-redness, tenderness to arm at site radiating to axilla.
came down with COVID; came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unnown , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Dec2022, outcome "recovered", COVID-19 (medically significant) with onset 13Dec2022, outcome "recovered" and all described as "came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Positive; (20Dec2022) positive again; (Dec2022) Negative; (13Dec2022) Positive, notes: When to MD office and the results were replicated. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021326262 same patient, different dose (1st dose) different event.;
Within minutes rash to neck and face, itchy. Rash spread to arms, abdomen and legs. Benadryl 50mg IM given at 2:08 pm. Rash resolving at 1415. 1445 totally resolved.
After 15 min TM  started having lip and tongue numbness  tingling . Then HA . Allergy to Benadryl     BP137/92  HR  78  O2 99%
Awoke in am with swelling of lips, especially upper and rash on upper thighs and left arm - with hyperaesthesia in areas of rash.
Fever days # 1 & 2 after vaccine, days # 14 & 15 fever, vomiting, day 16 maculopapular rash.
Breakthrough case admission after 4 vaccines  Moderna 2/23/21 lot# 023M20A;  Moderna 3/23/21 lot# 047A21A;  Moderna 11/4/21 lot# 939903;  Moderna 8/24/22 lot# 055A22A
This spontaneous report as received from a medical assistant refers to a pediatric patient of unknown age. No concomitant medications were reported. It was reported that a pediatric patient received an adult dose of VAQTA on an unknown date and there was no adverse reaction reported. It was unspecified whether the patient had sought medical attention or not. No treatment information was reported. At the time of reporting the outcome was unknown. Additional information is not expected.
12 hours after injection, felt moderate full body fatigue, full body muscle soreness, and joint pain.  Missed work 10/28/21, these effects last until 5pm 10/28.  Felt fine until about 1pm on 10/30/21, same symptoms, moderate full body fatigue, muscle soreness and joint pain until about 5pm on 10/31/21.  Felt fine until about 8pm on 11/1/21, left work early on 11/2/21, called the clinic at 1pm on 11/2/21.  Was advised this should still be normal until at least one week after injection.  Symptoms lasted until morning of 11/3/21.
Moderna 12+ 50mcg/0.5ml  (2023/2024) version was given to patient on 10/26/23  at 2:30 pm.  After it was given, on 10/27/23 it was found that the patient receiving the vaccine is 11 years and 7 months old.
On 2/5/2021 mom called clinic with c/o high fever of 104, no other symptoms. Advised of home treatment. On 2/6/2021 mom called and stated that fever still at 103 and circulation looked to be problematic. Mom called back a short while later and stated that after putting a blanket on patient, he appeared to be okay. MD gave precautions if fever went beyond 4 days to come back in. On 3/5/2021 mom called and stated that for the past 3 days the patient was admitted to DCMC and was diagnosed with ITP. Mom read that MMR can cause ITP so she was concerned.
pain at the injection site; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at the injection site".  Additional Information: The patient wanted to know how long the pain would last at the injection site. She mentioned that her arm pain was gone the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 17th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter is the spouse of the patient. The age at vaccination was not reported. The patient arm got hurts after vaccination. It was the arm where the patient got the injection. The patient had denied permission to contact their physician.
pain in left arm and glands under that arm, chills, fever, headache, body aches.
Information has been received from a consumer and a physician concerning a 9 year old female with CP, GI feeds, constipation, incontinence and a history of being a premie who on 09/12/1995 was vaccinated in the right arm with the first dose of varicella vaccine. In November 2001, the pt developed chicken pox. Subsequently, the pt recovered. No further info is available. The physician also reported that the pt's siblings, 2 females and 2 males, developed chicken pox after vaccination with varicella vaccine (WAES0112USA01251, 0112USA01252, 0112USA01254 and 01100739)/ The consumer reported that 14 patients at her children's school developed chicken pox after vaccination with varicella vaccine (WAES01110652).
I woke up at 4:00 am with heart palpitations and a resting heart rate lying down between 90-95.  Normally this should be 60-65.   Slowly walking a few steps would raise my heart rate  to 130.  Standing would be 112.     This continued for 6 hours.   After, my heart rate slowly started coming down, but was still elevated.  90's when standing.    12 days later, my heart rate is mostly back to normal.  Sometimes still  elevated above normal when exercising and takes a little longer to regulate between lying, sitting, standing and exercising.
Patient was administered 0.2ml of Pfizer vaccine to the left arm. She was calm when the vaccine was given both her father and sister who was going to receive the vaccine as well was in the booth. Once she received her vaccine she was perfectly fine she stood up and moved to the side and was trying to offer her sister some support so she wouldn't cry. dad was on the side of the sister who was getting vaccinated. when I administered the vaccine to the sister she cried a bit but we were just talking how it was done already that when I looked at the patient she fainted and fell sideways and bumped her head on the Otc shelving. Her eyes where open as she fainted. Her dad picked her up right away then the patient became alert and started crying. We did call the ambulance.  They sat for 15 minutes she stopped crying and just said her head hurt from the bruise on top right side of the forehead. Dad confirmed with me and the Paramedics  that she as feeling fine before leaving and that they were going to get a donut as a reward. Did tell Dad to just keep an eye on her since she fell or to make sure she didn't have a rxn.  She also drank some water before the paramedics came.
Pt was with family, room/ambient air was uncomfortably warm for all. Approx 8pm, pt noted to be shaking all over, eyes rolled back in head, moving head back and forth unresponsive. Called 911, temp 104. Seizure lasted about 30 seconds, pt in a daze x 10 minutes afterward. Taken to hospital ED for evaluation. No specific source identified for this simple febrile seizure. Pt recovered in ED w/o incident.
Medical assistant calling to report that a patient was inadvertently administered a 4th dose of GARDASIL9 on 06-DEC-2022; the second dose was given two years later; This spontaneous report was received from other health professional (medical assistant) and refers to a 14-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2020, at the age of 12, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (dose, frequency, lot #, expiration date, and route of administration were not provided).  There was an interruption in the dosing schedule between dose one and dose two and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot #, expiration date, and route of administration were not provided) was given two years later on 05-APR-2022 for prophylaxis (inappropriate schedule of product administration). The third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot #, expiration date, and route of administration were not provided) was administered on 01-NOV-2022 for prophylaxis. On 06-DEC-2022, the patient was inadvertently administered a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Extra dose administered), 0.5 ml, lot # U029033 (lot number was verified to be valid lot number) expiration date 13-MAR-2024, (route of administration was not provided) for prophylaxis.
On 02/21/2002 at 11am, pt's temp was 102 deg. F. and started Tylenol. At 5:30 pm, the temp was 103.9 deg. F. Called the doctor and Tylenol and Advil was ordered. At 6:30pm, temp was 103deg. F. Took to doctor on 02/22/2001 and the doctor said it was not shot related.
Pt woke in AM with fluid filled blister rash over body.  Pt complaining of itching.  Appointment today with diagnosis.  Symptom treatment.
Patient experienced syncope during the vaccine administration. She was sitting on the examination table and was laid down; with legs flexed immediately. Patient regained consciousness after approximately 10-15 seconds. She was instructed to remain sitting; was monitored for approximately 20 minutes for other adverse reactions. No other reactions noted or reported by the patient.
Severe local reaction about 3" Per mom "baseball size welt," was painful 2/6/08 and on 2/8/08 "itchy"
foot pain; knee pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (foot pain) and ARTHRALGIA (knee pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Femur fracture (fractures in her femur from a fall) in 2014 and Foot surgery in 2014. Concurrent medical conditions included Knee arthritis. Concomitant products included MULTI VITAMINS & MINERALS for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (foot pain) and ARTHRALGIA (knee pain). At the time of the report, PAIN IN EXTREMITY (foot pain) and ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
down for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for a day or two) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced DEPRESSED MOOD (down for a day or two). At the time of the report, DEPRESSED MOOD (down for a day or two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-077966, US-MODERNATX, INC.-MOD-2021-080428, US-MODERNATX, INC.-MOD-2021-080393 (E2B Linked Report).; Sender's Comments:  MOD21-077966:Crossed linked as per source doc US-MODERNATX, INC.-MOD-2021-080393:case for wife US-MODERNATX, INC.-MOD-2021-080428:wife case