chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient received an improperly stored dose of PROQUAD (recombinant human albumin), lot # M036158, expiry date: 12-FEB-2018 (dose and route of administration were not provided) reconstituted with sterile diluent (STERILE DILUENT) (lot # and expiry date were not reported) (captured in linked report # 1706USA000951). The data logger detected that the products had been stored in temperature from -14 to -10 degrees Celsius for 70 minutes. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000951.
Infant had a 2 minute generalized seizure, 24 hours, post vax. Seen by pediatric neurologist. Normal EEG; no treatment. Note: pertussis not given because pt had infantile spasms that started at 6 months of age (2 months after 2nd DAPT) and was treated with ACTH with complete resolution of seizures and normalization of EEG.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 15-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # K004204, expiry date 12-JAN-2017) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 5 year old male who on 8/1/06 was vaccinated with a 0.5ml dose of MMR II. Suspect vaccination administered that day included a dose of diphtheria toxoid + pertussis acellular vaccine unspecified + tetanus toxoid and a dose of Poliovirus vaccine. On 8/1/06 the pt experienced anaphylactic shock and was hospitalized. No lab diag test were performed. At the time of the report the pt had not recovered. There was no product quality complaint involved. Additional information has been requested.
There was tingling/numbness in the right hand fingers. There has been a burning in the right hand that comes and goes.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 30-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Saturday at 1:00am, I was feeling extremely nauseous, shivering, and achey. I had trouble sleeping and finally at 7:00am got up. I was nauseous, achey, fatigued, and shivering all morning. I had a temperature of 99.4 degrees. Between 11am-1pm on Saturday 02/27, I vomited three times. I had a horrible headache, stomach ache, and felt achey, cold, and weak all day. On Sunday, 02/28, my fever resided, and I did not vomit but still had stomach aches and slight nausea. I had eaten nothing out of the ordinary on Friday (made pizza at home like I do every Friday), and there were no other abnormalities during the day.
Swollen 3x3 red bump under vaccination site, sore arm for last 5 days
Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm) in a 70-year-old female patient 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-321418, MOD-2021-321420 (Patient Link).
not feeling well; normal flu-like symptoms; couldn't get warm; shooting nerve pain (in Achilles tendon, bottom of feet, top of hands; Pain made her gasp and shocked her each time; pain struck every 5-20 seconds and happened the entire night; Chattering teeth, chills; m it felt like all her organs was hurting so it was possible muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands) and DYSPNOEA (Pain made her gasp and shocked her each time) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands), DYSPNOEA (Pain made her gasp and shocked her each time), PAIN (pain struck every 5-20 seconds and happened the entire night), CHILLS (Chattering teeth, chills) and MYALGIA (m it felt like all her organs was hurting so it was possible muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 13-Mar-2021, MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands), DYSPNOEA (Pain made her gasp and shocked her each time), PAIN (pain struck every 5-20 seconds and happened the entire night), CHILLS (Chattering teeth, chills) and MYALGIA (m it felt like all her organs was hurting so it was possible muscle pain) had resolved.            This case was linked to MOD-2021-216640, MOD-2021-216640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06 May 2021 contains updated  outcome as resolved after 2 days
Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with no pertinent medical history and no known drug allergies who on 22-SEP-2009 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot number reported as 662664/0981X, invalid for GARDASIL, but is a valid lot number for PNEUMOVAX 23. There was no concomitant medication. At the time of this report, the patient was pregnant. Physician assistant believed the day of conception was the day of the first dose of GARDASIL. A pregnancy test was performed on 22-SEP-2009 and the result was negative. The patient sought medical attention through a prenatal office visit. The patient's last menstrual period was 08-SEP-2009. Expected date of delivery was 15-JUN-2010. Follow up information has been received via telephone call from an obstetric nurse indicating that the patient's pregnancy was "relatively uncomplicated". She had a choroid plexus cyst noted on her mid-trimester fetal ultrasound but everything was normal at the follow-up ultrasound. The patient was scheduled for an induction on 24-JUN-2010, the nurse suspected it was because she would have been 41 weeks gestation, and she could not find any other indication when asked. The induction resulted in a primary cesarean section on 24-JUN-2010, and the patient delivered a baby in good health. She stated there was no congenital anomalies. The nurse confirmed that both the baby and the mother were in good health at her post-partum visit, and the mother recovered from her cesarean without complications. The infant's experience has been captured in WAES 0911USA02673B1. Upon internal review the induction that resulted in a primary cesarean section was considered to be another important medical event. No further information is expected.
Tachycardia; Tingling in the tongue; This is a spontaneous report from a Pfizer-sponsored program. A contactable female physician (patient) of unspecified age reported herself received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 21Dec2020. Medical history and concomitant medication were not reported. 2-3 hours after the vaccination (21Dec2020), the patient experienced tachycardia. She took diphenhydramine (BENADRYL) 25 IM. It went up and down before it settled down. She also had experienced tingling in the tongue on 21Dec2020. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown. It was reported as non-serious.  Information on the lot/batch number has been requested.
This spontaneous report as received from a Healthcare worker refers to an approximately 6 month old patient of unknown gender. On 26-JUL-2013 the patient was vaccinated with PNEUMOVAX23 injection (lot # and expiration date unspecified). The reporter stated that patient (birth date 28-DEC-2012) received the dose of PNEUMOVAX23 in error, child was to receive a pneumococcal vaccine, manufacturer unspecified. No adverse event reported, no product confusion discovered, just medication error. The patient's outcome was unknown. Additional information is not expected.
Pt was a non-responder p/6 doses of Hep B vax; doses 4, 5 & 6 were specified as Engerix-B given 19DEC90, 2JAN91, 18JUN91;
Within 3-4 weeks of receiving my second dose, I started having abdominal bloating and diarrhea. I went to see my doctor and described my symptoms. I was later diagnosed with an infection in my small intestine. Within 2-4 weeks of treatment for that, I started to notice fatigue and low grade fevers. I was later diagnosed with Reactivated Epstein Barre Virus. My viral load was 30 times higher than it should be. 21 was considered normal and I was at 600+. Within 2 weeks after that, I experienced severe abdominal pain. I went to the ER. By the time I got to the hospital, the pain was worse. The pain moved from my right side of my abdomen to my back and right shoulder. I was diagnosed with fatty liver. I had a severe electrolyte imbalance, blood in my urine, severely low blood pressure and it hurt to breathe. I did a follow-up with my PCP, and most of my lab work has improved. As of today, I am waiting on results for my urinalysis. The only thing still abnormal is the protein in my urine. At the ER, my protein showed low, but at my PCP, my protein was showing high (this was from a blood sample.) During this timeframe, I have been having hormonal imbalance. I've had low estradiol levels. My DHEA has improved, but my AMH has gone down. I'm showing a decrease in fertility. I've never had any complications with this before.
This is an 85-year-old female with a past medical history of underlying dementia hypertension and vitamin deficiency who is a resident in an assisted care facility. Recently there were resident who were found to be positive for coronavirus infection over there hence patient got tested he was found to be positive. She was hence referred to the ER for infusion of regeneron. After that patient was kept under observation in the hospital, she had an MRT for new onset atrial fibrillation with rapid ventricular rate, she start got started on Cardizem drip and was seen by cardiology.
patients received monovalent vaccine as a booster dose after 9/1/22. no side effects or symptoms, patients notified.
Patient experienced arm pain starting 5 hours after administration of vaccination, it kept her awake all night and she was also  experiencing nausea in to the 24 hour period. Pharmacist recommended taking tylenol and or NSAID if approved by her doctor as well as using lidocaine to relieve the pain in the arm. She was going to try those interventions and report back.
Information has been received from a lawyer for FOSAMAX (MARRS#1210USA003120). The patient reported that in 1999 she participated in a double blind clinical trial for shingles. In 2000 she was given a placebo and given a shingles vaccination ZOSTAVAX at the end of the trial. In JAN 2011 the patient experienced shingles. The outcome of shingles was unknown. This is one of several reports from the same source. Additional information is not expected.
profusley sweating,blood presure dropped,faint-dizzy,nausea,diarrhea,weakness.
Leg started swelling the day of the vaccine. Became painful and eventually became unable to move, according to patient. She was given a prescription for Xarelto,
Patient reported pain in her (Left) arm that radiated to her breast and armpit region - subsided within 5 minutes. Patient was cold and could not get warm. Later patient experienced tremors/shaking. No redness, bruising or swelling at injection site. Still experiencing pain.
Patient contracted COVID-19 after being fully vaccinated.  No booster Muscle Aches, sore throat, and cough
Immediately felt dizzy, had a crawling sensation up both sides of her neck and a tightness in her chest. She said she had a hard time taking a deep breath
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date were not reported). Concomitant medication was not provided. On an unknown date the patient reacted funny after receiving PNEUMOVAX 23. The outcome of "reacted funny like this to " was unknown. This is one of two reports from the same reporter. Additional information has been requested.
pt w/macular papule fever rash 2wk p/vax w/fever;
waves of pain a week after the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (waves of pain a week after the shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 028L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (waves of pain a week after the shot). At the time of the report, PAIN (waves of pain a week after the shot) outcome was unknown.            No concomitant drug medication was reported.  No treatment medication was provided.   This case was linked to MOD-2021-417554, MOD-2021-058152 (Patient Link).
redness, swelling, slight rash, slight pain around injection area. Area affected is about 3" by 5". Received the injection on Friday 1-22-21. Today Sunday  1-31-21 area still reacting.  The reaction did not begin until 3 or 4 days after the injection
Patient received the first covid 19 vaccine shot on 11/25.  Three days after the shot she started asking a lot of questions and seemed very confused about the most basic questions.  We thought this was a phase at the time.  She received the 2nd shot on 12/15 and within 5 days had completely deteriorated neurologically.  She developed acute severe OCD, significant age regression, and was unable to function.  She lost the ability to communicate, just pointing and grunting for things that she wanted.  She became completely emotionally disconnected (unable to say I love you or sorry or anything with emotion).  Almost overnight she turned into a 4 year old with autism and ocd.
This is in follow-up to report (s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse concerning a 7 year old patient who on 18-AUG-2008 was vaccinated with ZOSTAVAX (lot#: 659406/0298X) instead of VARIVAX. This was a human error. No adverse events were reported. The patient sought unspecified medical attention. Additional information has been requested. Information has been received from a licensed practical nurse concerning a 7 year old male who on 18-AUG-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (MSD). This was a human error. The nurse picked the wrong vaccine to give the patient. No adverse events were reported. The patient sough unspecified medical attention. Additional information has been requested.
First my child had pain in her arm and then began to have flu like systems and muscle and joint aches then after falling asleep on Friday April 22, 2022 she awoke crying and in pain on Monday. I took her to the doctor.
Five days after shot I had rapid pulse (120) and felt weak.  Ten days after shot I felt very weak in morning and couldn't stand long enough to shave.  Rapid pulse again (120).
This spontaneous report was received from a physician referring to a 11 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 22-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Rash "all over"; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 6th May 2019, the patient received Shingrix (intramuscular). On 8th May 2019, 2 days after receiving Shingrix, the patient experienced generalized rash. On 11th May 2019, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. 2 days after receiving Shingrix, the patient experienced rash all over, which lasted for 3 days and then resolved without treatment. The patient did not report this to the pharmacy until the reporting date. The reporter consented to follow up. The pharmacist granted permission for follow up.
Extensive redness and streaking at injection site. DR said it was cellulitis. Gave prednisone and cephalexin.
10-15 min after shot, became pale, said he is not feeling well, throat is hurting. Had cold clammy skin. Vitals - pulse 75/min BP - 104/66. Was given BENADRYL PO and epinephrine 1:1000 SC, felt better. Became sleepy. Was closely observed for almost an hour had stable vitals.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, TENDERNESS/SWELLING OF LOCAL LYMPHNODE ON INJECTION SIDE, PAIN/SWELLING INJECTION SITE Narrative:
Severe rash over arms and upper chest with eventual blistering and secondary infection with staph aureus resulting in bacteremia.
Dizziness, Headache & Myalgia Narrative: missed work following 2nd dose of vaccine
localized reaction to injection site.  Swelling and redness to area while still in office approx. 5 minutes after given. Waited 10 minutes and seemed to have stopped. We drew a circle around area, gave benadryl and told mom to return tommorrow to recheck.  Also told mom to call with ant changes
11 AM-dizzy nausea headache and low grade fever.  12pm ate food slept felt slightly improved but low grade fever continued.. reawakened at 2 pm headache continued, nausea was periodic. Total loss of appetite. Laid down and slept till 9 pm. Woke up slightly hungry couldn't eat. Took nighttime cold and flu relief drank tea vomited approximately 5-10 minutes after the tea and medicine.
Patient gradually developed a bifrontal headache which increased in intensity with a single episode of non-bloody/non-bilious emesis. Further described as a throbbing and occasionally sharp headache worsened with bright lights. No vision changes.  Treatment: -IV hydration -IV morphine x1 given in ED -Rx for vicodin (provided quantity of 5 tablets)
Patient complaining of fever, stiffness in neck. Pain in back running down arms and legs. Arms and legs feel "Tired". Symptoms are improving daily and he will see physician Monday 11/1/10.