chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pressing on her spinal cord; This is a spontaneous report from a contactable consumer reported for herself. This female patient of unspecified age (age:67; unit: unknown) received the 1st 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. The patient stated she had the first dose of the vaccine and scheduled the second dose for 3 weeks later, but apparently 3 weeks, her cervical spine surgery fell on that day; (it's pressing on her spinal cord. She was fighting becoming paralyzed). The patient asked if any window, flexibility. The nurse told her there's a 3 day before and 5 day window after, but no one believed that's correct. If she missed and she couldn't have the vaccine (second dose), the patient asked whether she would have to start over. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Began this morning at 6am with sore left deltoid radiating across shoulders and a light headache. Progressed to low grade temp 99.5 with intermittent chills. Oral temp up to 101.0. Resting heart rate fluctuating to 105-117 and pulse oximetry dropping to 92-93. Intermittent palpitations
Noted small wheal like area below injection site with "purplish" hue around injection site.  Dr. looked at site and stated it was a normal reaction.  Benedryl was not given like the other patients were given.
Dizziness; Extreme fatigue; Leg cramps; Headache; Vision changes; Joint pain; Anemia; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 07Apr2021 at 18:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer, diabetic, asthma, anemia, and allergy to IVP dye. The patient previously took avelox, morphine, benadryl and compazine on unknown dates and for unknown indications and experienced drug allergy. Concomitant medications included cyanocobalamin (VITAMIN B12), vitamin d nos (VITAMIN D), insulin aspart (NOVOLOG), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), insulin detemir (LEVEMIR) and gabapentin (GAPATIN); all for unspecified indications and since unknown dates. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 17Mar2021 at 17:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 20:00 the patient experienced dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain and anemia. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain, anemia and included treatment with meclizine (MANUFACTURER UNKNOWN) and MRI on an unknown date. On 14Apr2021, the patient underwent COVID 19 test (nasal swab) and the result was negative. The clinical outcome of the events dizziness, extreme fatigue, leg cramps, headache, vision changes, joint pain and anemia were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shingles; Information has been received regarding a case in litigation for the lawyer, concerning a 67-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies were not provided. On 25-JUL-2017, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX), (lot number, expiration date, dosage information were not provided) at pharmacy. As a result of her receipt of Zoster Vaccine Live (ZOSTAVAX), on 28-JUL-2017, the patient was caused to suffer shingles including any and all of its sequelae, it has been caused to suffer dangerous side effects, including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physician pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the time of the report, the patient's outcome was not recovered, and the reporter considered the event of shingles to be related to suspect therapy. The event of shingles was considered as disabling by the reporter, since it caused permanent injuries.
Parent reported child with fever spike to 103 F, nausea, body ache, slight tremors which went away and mild sweating.  Parent spoke with school nurse the next morning and also called her physician.  Physician advised hourly temp check and stated this was a normal response to Tdap/Hep A.  Parent declined to use a fever reducer - Tylenol or ibuprofen.  Physician aware of parent's decision.  24 hours later child's symptoms were improving with decrease in body temperature.  48 hours later, 5/30/14,  I spoke with the mother via phone and gathered information for Vaers report.  Mother states child is improving.  Fever now reduced to 100 F.  All other symptoms have subsided. She informed me of her discussion with her physician's office and school nurse.  I advised her of normal after shot care for child which can include Tylenol/Ibruprofen.  She is aware of this option, but wishes to let her child fight fever naturally.  Child is improving.
severe migraine severe vertigo followed by disequilibrium  i could not walk for four weeks.
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient. No additional clarifying statements or details provided. See related AE case numbers in notes. No additional AE. No PQC.  ?    Names of vaccines involved: ROTATEQ (Lot: 18798; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-JUL-2022, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 milliliters once orally as prophylaxis (lot number: 1879870, which was determined to be valid, with an expiration date on 16-OCT-2023) (product storage error) (strength and scheme was not reported). The administered dose underwent a temperature excursion of 34.4 degrees Fahrenheit (F) for 1 hour and 7 minutes. It was reported that a previous temperature excursion of 66.7 degrees F for 13 hours and 52 minutes occurred. No additional adverse event was reported.   This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2210USA005624: US-009507513-2210USA005916: US-009507513-2210USA005917: US-009507513-2210USA005929: US-009507513-2210USA005937: US-009507513-2210USA005994:
Fever 101. 01/16/2019 06:55 PM: He presented for 6 month well check. The child has 4 bottles per day breast milk and formula and 3-4 ounces per bottle. Foods include cereals, vegetables, fruits, has not started sippy cup and taking vit. D. The child has 6 or more wet diapers per day, has a straight urine stream and has hard stools. During sleep, the child is on his/her back, on his/her belly, on his/her side, in own crib, in the parents' bed, through the night (6 hours minimum), at least two short (1 hour) naps during the day, able to fall asleep by self and able to comfort self at night. The child rolls from front to back, rolls from back to front, rolls over both ways, sits with support, stands when held in position, bears weight, creeps or scoots, has raking grasp, bangs two cubes together and transfers objects hand to hand. Currently, the child babbles, turns toward sounds, recognizes own name, does not understand "no" and does not understand "bye". The child shows pleasure in interactions with others, seeks interaction with others, is interested in age appropriate toys and shakes toys. I discussed the following topics with the parents assess and remove lead exposure risks, childproof floor level items, cover all sockets, keep all cabinets/poisons/medicine locked, poison control number near the phone, learn infant/pediatric CPR, never leave child on bed, diaper changer, or couch, never leave child in bathtub, swimming pool gated/secured, put hanging cords out of baby's reach, begin teeth cleaning, fluoride drops if inadequate in the water, call for rectal temperature greater than 100.4 F, 38 C, establish bedtime routines, transitional objects, in car seat each time your in the car, rear facing infant seat in the back seat, introduce solids with a spoon, no bottles in bed - begin sippy cup, no honey, eggs or peanut butter until at least 1 yr old, no seeds, popcorn or other food choking hazards, no infant walkers, no small toys - choking hazard, no smoking in the house, smoke alarms in the house, sturdy cribs with side rails in the raised position and water temperature set at less than 120 degrees F. 01/17/2019: He presented with fever. It is described as acute. The symptom is sudden onset. The symptom started 1 days ago started yesterday 1/16/19 at night. The temperature is 100 degrees 100.7. Significant medications include TYLENOL given today at 9:00 AM, per mom. Important triggers include no known associated factors. Pertinent findings include fussy and poor appetite.
Initial report received on 18 November 2009 from a consumer, who is the patient. A 39 year old female patient, with allergies to codeine and penicillin and a history of hypothyroidism and a pituitary tumor, received a left deltoid intramuscular injection of FLUZONE (lot number not reported) on 28 October 2009. Concomitant medication was SYNTHROID. She received no other vaccinations in the four previous weeks. The patient experienced a very sharp pain upon injection in the left deltoid. At the time of the report, the pain was persisting, it was waking her up at night if she rolled on her side, and the area felt cold. She also had occasional tingling in the fingers of her left hand. The patient was seen by her primary care physician who ordered an x-ray and MRI. The x-ray revealed that the bone was not affected. The MRI was scheduled for 20 November 2009. Corrective treatment was not reported. The patient had not recovered.
Flu like symptoms. Pain scale is 8. Soreness. Tenderness at the site of injection. Swelling. Can't lift his arm due to pain.
Coughing and wheezing within 15 minutes, over the counter Benadryl and inhaler, but that didn't work, medical professional onsite noticed wheezing continued and advised that I go to the hospital, transported by ambulance, DuoNeb by oxygen mask, that helped, epinephrine and steroids in the emergency room, discharged 3 hours later
Initial and follow up information has been received from a Certified Registered Nurse Practitioner (CRNP) concerning a 16 year old female student with asthma who on 21-APR-2007 at 9:30 AM was vaccinated IM with a first dose of Gardasil (lot #0210U not valid). Concomitant therapy included montelukast sodium and albuterol over the counter (OTC)-10. On 21-APR-2007 at 5:00PM the patient developed exacerbation of asthma with activity during two basketball games one at 5:00PM and one at 8:00PM. She used albuterol 7 times during the basketball game. Normally she didn't need to use the albuterol that many times. On 22-APR-2007 the patient recovered in the AM. Additional information is not expected.
Large red, swollen, warm area on right upper arm. Dx cellulitis, antibiotics started.
Vaccine Received on Wed 3/10/2021. On Saturday - shortness of breath, very elevated resting pulse (by 25 bpm) reduced oxygen saturation (87 on oximeter vs 95), moderate ongoing chest pain.  Primary care doctor advised to go to ER.  ER visit resulted in misdiagnosis of Heart Attack which was later changed to heart inflammation.  Troponin levels elevated and stayed elevated and continue to be elevated 8 weeks later.  AFter 8 weeks Troponin levels still elevated and pain occurs upon anything more than modest exercise.  Patient has a history as an edurance athlete.  All other tests on heart function - stress test/ Ekg, perfusion, echo - show a high peforming heart - no other defects other than heart inflamation.
At 3:20 Client report pain in Left Forearm to nurse  Client reports throbbing pain in Left Forearm  Client states her arm feels like ?it?s going to explode? Client reports that she felt dizziness, pain in her chest, and pain in her back immediately after the injection around 2:30 Client was with her employer and did not want to draw attention to herself by saying anything to observation attendants or nurses She stayed past her time of approx. 2:40 because she did not feel safe to drive Client states she is no longer having chest pain or dizziness At 3:22 EMT present Vitals taken electronically: BP 137/102, Pulse 80 Client reports that she only has pain in her left forearm No swelling noted Client no longer having any previously experienced sensations such as chest pain, pain in her back, or dizziness At 3:30 Vitals taken: O Sat 99, Manual BP 110/ 90, Pulse 78 Client reports that her arm feels a lot better Client states she feels well enough to drive home Client able to ambulate to her car unassisted
Ache/Pains; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Ache/Pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Patients states has 2nd dose of COVID-19 Vaccine and was under the weather like Flulike symptoms, aches, Pains.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced pain on injection site immediately after injection.  An ice pack was given to the patient.  Minor erythema developed at injection site.  Difficult to differentiate whether or not it was from the ice pack.  Shortly thereafter the patient developed breathing problems that became increasingly worse.
Pt states he felt dizzy, lightheaded, and nauseous  approximately 2 minutes after vaccine. After about 20 minutes all symptoms subsided.
Fatigue, fever, headache, joint pain, malaise, muscle pain and pain at the injection site for approximately 48 hours after receiving vaccine.
Respiratory distress; Pneumothorax; This is a spontaneous report from a contactable nurse (patient's mother). This nurse reported for both mother and baby. This is the baby case.   A 34-year-old mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 30Apr2021 15:00 approx as dose 1, single and on 14May2021 15:00 approx (lot number: EW0153) as dose 2; intramuscular in the left deltoid for COIVD-19 immunization. The male neonatal patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via transplacental. Mother's medical history includes anxiety, insomnia and pericarditis with pericardial effusion Jun2019. The mother did not smoke, drink or illicit drug use during this pregnancy. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO), minerals NOS, vitamins NOS (PRENATAL VITAMINS), diphenhydramine hydrochloride (UNISOM), zolpidem tartrate (AMBIEN) and anti-D immunoglobulin (RHOGAM). On 14May2021, the mother received 2nd dose of vaccination, 29 weeks and 3 days pregnant. On 15May2021 (as reported), the patient started having contractions. On 14May2021, the mother went to labor and delivery, admitted for preterm labor. The mother delivered premature live birth on 28Jun2021 at 36 weeks due to IUGR & oligohydramnios via C-section. Apgar score: 1min 6; 5min 7. The baby (patient) stayed 1 week in the NICU due to respiratory distress and pneumothorax. It was reported that this may or may not be all related to the COVID vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021691803 mother case
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent condition, medical history and concomitant therapy provided. On 09-NOV-2015, the patient was administered with an expired dose of PNEUMOVAX 23 first dose, intramuscularly, lot # K005402, expiration date: 07-NOV-2015 (exact dose was not reported). There were no adverse effects reported. Additional information has been requested.
Parent reported 1 day following vaccination (8/12/09), child's arm (from Shoulder and to just above elbow) increased redness, warmth to touch, and hardness.  Parent stated this lasted about 4-5 days.  Upon viewing today (9/9/09), left arm was back to normal - no adverse effects noted. using both arms equally.
Information has been received from a 73 years old female patient (also a practicing chiropractor) referring to herself. The patient's medical history and concurrent condition were not reported. Concomitant therapies included unspecified cholesterol and blood pressure medications. On an unknown date in May 2016, the patient received a dose of ZOSTAVAX 19400 PFU vial (lot #, expiration date and dose were unknown), intramuscularly. On an unknown date in May 2016 since the administration, the patient had joint pain and myalgia in her hands and sacrum. Sometimes it was severe. The patient also experienced blisters, which cleared up several weeks after the injection. Prior to receiving the vaccine, the patient did not have any of these symptoms. The patient sought medical attention on an unknown date. She had been treated the joint pain and myalgia with needle acupuncture, cold laser, ultrasound, etoposide, vinblastine and ADRIAMYCIN and an unspecified homeopathic virus treatment. The treatment was administered by chiropractors in the office that she practices from. The outcome of joint pain and myalgia was reported as not recovered. The causality assessment was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in the left arm with slight swelling. patient was complaining of hot flashes. Patient said only had a muffin and coffee to eat and drink all day.  No aberrations  Vitals- HR: 55 - RESP: 14 - BP: 129/85 Sp02: 99%
Patients daughter called. Patient complained of: fever, pain at injection site (worse than previous flu shots), throat pain/soreness.
Patient presented to the clinic Monday morning with a large local reaction. At the site of injection there was swelling the size of patient's palm, bruising and tenderness around the area. Patient complained of pain in moving and lifting arm. Pt states he iced it over the weekend with no relief.
Patient started to feel achy from head to toes and had severe stomach upset. It was severe enough that patient reported to ER.
At the injection site members left deltoid it turned red, half dollar in size, and there was a pea size area that was hard. Member was given 25 mg of Benadryl and PA-C also assessed the site. Member waited 15 minutes in the clinic after given Benadryl and there was not further reaction. The redness was the same and did not spread. The member reported she was feeling "fine".
5 out of 100 patients have this rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (5 out of 100 patients have this rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (5 out of 100 patients have this rash). At the time of the report, INJECTION SITE RASH (5 out of 100 patients have this rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
2"x4" red, raised patch surrounding shot site. Treated with Augmentin, Motrin, Benadryl.
Headaches, malaise, loss of energy and enthusiasm, significant fatigue yet inability to stay asleep or nap, fuzzy mentality, loss of appetite (I've lost 5 pounds), periodic temperature (one degree above normal), skin and muscles "tingly". Symptoms have been present since vaccination. It is now about 5 weeks later. Still feeling lousy, still missing partial days of work, still not going to the gym (used to go 3-4 days/wk). For me, I would evaluate taking this vaccine as an overall bad idea. I've been miserable since. My Dr (who suggested the vaccine) says I am a rare case, and should "wait it out".
experiencing headache after the first dose on 9th of April; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer. This consumer (patient's husband) reported for a female patient (wife) that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number and expiration date was not reported) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient, experienced headache after the first dose on 09Apr2021. Caller stated that they already went to the hospital and was given medical advice already. Her wife was better now, he said. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient received both BOOSTRIX and FLUZONE IM in left bicep- Pt has baseball sized swelling at injection site.
Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient.  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Jaw tightness approximately 40 min after injection. Approximately 10 hours later pt. is feeling "less tight".