chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, nausea, heart beat at 124 beats per minute, feelings of passing out off and on, and weakness on 11/28/2012. On 11/29/21012 at 7:00AM, symptoms included chest pain with difficulty breathing off and on until 9:00AM, increased weakness, headache, constant nausea, dizziness and fast heart beat between 106-120 beats per minute. Went to the emergency room per primary care providers instructions around 5:00 PM. Upon arrival to ER, left arm and hand was tingling and went numb. Had temporary paralysis entire left arm for spouse minutes. CT of brain came back normal. Bloodwork came back normal. EKG was normal. Was given IV fluids, Benadryl, Phenergan, and Torodal. Symptoms subsided within couple hours but then had a reaction to one of the medications given to me per ER physician but he wasn't sure if it was from the Benedryl or Phenergan.
This spontaneous report as received from a patient's mother refers to a 11 year old female patient with none drug reactions or allergies. Pertinent medical history included tonsils and adenoids removal. In October 2013 (date unspecified) the patient was vaccinated with a first dose of GARDASIL (lot # J007354, expiration date 20-FEB-2016, injection (dose and route not provided). On 10-DEC-2013 the patient had administered in her left arm a second dose of GARDASIL (lot # J007354, expiration date 20-FEB-f2016, reported as which may had been from the recalled lot) injection (dose and route not provided). On the same day, 10-DEC-2013 the patient was vaccinated with an unspecified flu vaccine in her right arm which may had been AFLURIA (dose, route, lot number and expiration date not provided). No concomitant medication was reported. On 10-DEC-2013 the patient experienced pain at the left arm injection site. On an unknown date (in December 2013) the patient sought medical attention for the funny lump on her chin. The approximately 20-DEC-2013 reported as about one week ago, the patient sought medical attention for the funny lump on her chin. The funny lump was diagnosed as possibly a cyst or fatty tissue. No treatment was prescribed. No treatment was reported for the pain at her left arm injection site. The outcome of the pain at the left arm injection site was reported as resolved on an unspecified date in December 2013 and the site was at the time of report still a little swollen (onset date approximately in December 2013). The outcome of funny lump on her chin/cyst or fatty tissue was not reported. The relatedness between vaccination with GARDASIL and events was not reported. The patient did not recover from the event of vaccination site swelling at the time of this report. The relatedness between vaccination with AFLURIA and events was not reported. Additional information has been requested.
Case number PHEH2015US025058 is an initial spontaneous report received from a pharmacist on 28 Nov 2015. This report refers to a male patient (also the reporter) of an unknown age. Medical history and concomitant medications were not reported. On an unknown date, the patient was accidently exposed to FLUVIRIN (batch number: not reported) as the vaccine splashed into his eyes while he was trying to draw up FLUVIRIN into a syringe. The patient rinsed out his eyes, but his eyes stung a little bit. The outcome of the events was reported as unknown. Seriousness and causality of the events were not reported.
Fever, urticaria, pruritus and nausea vomiting. Hydrocortisone BID.
14 days after MMR and Hep B given Pt. developed generalized severe arthralgia's, headache decrease appetite with weight loss. Arthralgia's lasting .2 wks.
Moderna COVID?19 Vaccine Late in the day on 24MAY2021, I started to experience the side effects of the COVID19 Moderna vaccination with which I was familiar:  redness/tenderness around the injection site, sore arm muscle, hot/cold flashes, slight fever.  However, the next morning (25MAY2021, between 7-745am) after receiving the 2nd COVID19 Moderna vaccination, I had a blood-tinged vaginal discharge.  I was expecting my next menstrual cycle to start on 30MAY2021.  It would be extremely odd for me to start my next cycle 5 days early.  I am pretty regular with my cycle - every 28 days plus or minus 1-3 days.  To be 5 days early would be atypical for me.  As such, I decided to wait to see if it progressed.  It did not - on Tuesday or Wednesday.  I finally officially started my menstrual cycle on 27MAY2021, 3 days early, which is typical for me.  As it could be construed as a side effect from the vaccination, I wanted to report this event.
I had a headache, chills and did not feel very well. I advised my husband that I was not feeling well and we went home. It did not go away for a few days. I did I home test for COVID 19 and then went to have the test done with a medical professional and it was positive.
FEELING SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling sick was not reported. This report was non-serious.
After the 4th vaccine was given (menangitis), my son almost fainted. His vision became tunnel vision and he said his ears felt plugged...his arms were drenched in sweat and he became very lethargic. A second nurse rushed in and put an amonia patch under his nose to prevent the fainting spell...he was then wheeled to an observation room where is BP was at lowest 102/49. He was given apple juice and the doctor arrived to perform about 5 more BP checks and after about 10 minutes had him slowly stand and walk. He released us as since my son said he was feeling ok and felt no dizziness.
Immediate pain /ache at injection site Approximately 6 hours later experienced headache and body aches. About 12 hours after vaccine I had chills, fever, vomiting diarreah, and almost passed out.  The vomiting and diarreah went away after one episode. The headache/body aches continued throughout the next day. The chills/fever were gone by morning on April 7. I developed a red rash around the injection site 2 days after receiving the vaccine and as of today, April10, I still have some redness and soreness.
This spontaneous consumer report (initial receipt: 24-Aug-2012) concerns a female patient. On an unknown date the patient received flu vaccine (manufacturer, brand name and batch number were not provided). After receiving the flu vaccine, the patient had a bad experience. The event outcome was not reported.
Administration Error: A 67 Year old female patient received her second booster dose one month after receiving her first booster dose, an action which does not comply with established guidelines for the administration of second booster doses.
I?m 1/21/22 I developed a sore throat and fever, and chills. I?m 1/23/22 I tested positive for Covid-19.
Patient presented at the pharmacy on 8/9/2020 at about 1215pm, red rash, swelling and tenderness on the injection site, affected area is about 3 inches in diameter.  Advised patient to take Tylenol for pain.
About 8pm on 3-12-12, began to have chills and a headache. She also began to have soreness at injection site that began about 12pm on 3-12-12. On the morning of 3-13-12 she woke up feeling weak with headache. Chills ended during the night.
LETHARGIA ASLEEP BY 9:30 PM SAT, SEVERE MIGRAINE HEADACHE WITH VOMITING THAT WOKE ME UP FROM SLEEPING 3:30 AM SUN, FOLLOWED BY DIARRHEA NEXT AM WITH COUGHING AND SORE THROAT AND WORSENING EAR BLOCKAGE LEFT SIDE AND SINUSTIS
pt began having cramping & muscles contracting; appeared in pain; contacted medical advice told to give warm baths, massages to innoculated area & APAP; if not improved take to clinic 17MAY91;
Headache Narrative:  severe headaches that disturbed sleep for 10 days  Other Relevant History:
Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received a dose of DAPTACEL; lot number C2934BA received on 27 June 2008, 2 doses of PENTACEL; lot number C3176AA received on 25 August 2008 and lot number C3227AA received on 20 January 2009, and a dose of DAPTACEL; lot number C3084AA received on 25 August 2009 (routes and sites of administration not reported). The subject developed a paroxysmal cough with a whoop on 06 July 2012, approximately three years after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 12 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
shingles rash /breakout; This case was reported by a physician via sales rep and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles rash or breakout after being immunized.
pt brought to ED from a nursing home (name of facility not in med records) with increasing SOB and confusion; acute on chronic hypercapneic respiratory failure; O2 supplementation; tested positive for COVID; COVID pneumonia; admitted to hosp; DNI; steroids given; O2 demand increased; placed on BiPAP; experienced A Fib with rapid ventricular response; eventually converted to sinus rhythm with amidarone infusion; unable to tolerate oral intake; DNR/DNI; transitioned to comfort care; removed BiPAP and pt passed away in the hospital
1wk following vax pt exp abd discomfort w/o diarrhea;devel limb weakness & fasiculations;became parapatetic & then wheelchair bound;pt hosp;tone sl dec;vibratory sensations mildly dec @ great toes;
Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body aches Day 3, fever 101.3, chills, fatigue, body aches, rash at injection site, arm pits, feet, headache, unable to sleep, stomach ache Day 4 , no fever, very weak, headache, same rash, can not concentrate, stomach ache
After the first Vaccine on 3/15/2021, patient developed a raspy voice the next day. She thought it was allergies. She took the second vaccine 4/12/2021 and began getting a slurred speech, tinging nerves, and difficlty breathing and shallowing. One month later she had weakness and limited use of her hands and arms. She went to her PCP who ran blood test. After she went to the emergency room at Hospital and they referred her to a Pulmonary Specialist who referred her to Speech Therapy. The Speech Therapist contacted the Pulmonary Specialist to refer her to a Neurologist. The Neurologist discovered she had ALS after testing and referred her to ALS Clinic. Patient did not show any ALS symptoms, and was working daily up to April 15. Between April and December, patient has lost 70 pounds.  Patient is on breathing and cough machines. She is unable to dress herself, pull her clothes down to go to the bathroom, brush her teeth, or cut her food up when dining because her hands are so weak.   Patient applied for insurance in October but was turned down in November. She appealed it in January. I have moved patient because she is unable to take care of herself. Patient needs insurance to see doctors and get into Hospital ALS Clinic.
1/13 vaccine @ 4:15 About 15 minutes later, the side effects I had flush feeling in my head, chest.  Once I got home, a weird sensation in my tongue. I constantly felt my tongue. Those 3 side effects lasted for 3 days.  PCP examined me. I could breathe fine. Told me to take Benadryl and then gave me a prescription to take for the 2nd vaccination.   My arm was slightly sore.
ADMINISTERED PAST THE CURRENT REFRIGIRATION BEYOND THE USE DATE AS LISTED IN EUA
Patient received vaccines, per mom patient, stood up, then became very "wobbly" and began to "flip" eyes. Patient mom placed her on the floor. Patient passed out, urinated on herself, was unconscious for few seconds. Legs elevated, given juice cracker when she came back to consciousness.
This spontaneous report was received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M018957 with an expiration date 22-NOV-2017, lot# M031807 with an expiration date 02-APR-2018, lot# M031807 with an expiration date 02-APR-2018, lot# M025568 with an expiration date 07-NOV-2017, lot# M006112 with an expiration date 16-NOV-2017 and lot # M038717 with an expiration date 24-APR-2018 for prophylaxis (doses were not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced the temperature excursion between 32 to 36 degrees Fahrenheit for 600 hours, 24 but less than 32 degrees Fahrenheit for one hour and over 46 but less than 77 degrees Fahrenheit for 45 minutes. A digital data logger was involved. there were more than 10 previous temperature excursions. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA010803.
Mental confusion - just rest and sleep; abated after a few days Angina -Nitrostat  tablet taken; symptoms abated; angina returned about 3 more times in a two week period following the first angina event. Nitrostat given to relieve symptoms.
Patient seems to be experiencing hives. The hives seem to appear with contact/stress and then often go away with an hour or 2. The hives were discussed with our pediatrician and she recommended it may or may not be connected to the COVID vaccine, but we should report the potentially adverse reaction.
I tested positive for COVID-19 on 11/21/22. I had a headache, body aches, nausea, and a fever of 101. I developed a cough later. I contacted my doctor and was prescribed Prednisone and Lagevrio. I did not take the Lagevrio though. I am feeling better now, but I still get a little winded from time to time and my blood pressure is still a little high.
Information has been received from a physician via a company referring to a female patient. The age of the patient was reported as "in their mid 60's" or "around 89 years of age". The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N019838, expiration date 16-FEB-2019; dose, strength unknown) intramuscular in unspecified side of deltoid for prophylaxis. On 28-DEC-2017, the patient had severe pain in the injection area for a couple of days. There was no redness or swelling on the  area. At the reported time, the patient was better. The causality between pain and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA003160:
Whole arm was swollen and red; Whole arm was swollen and red; Low grade fever; This is a spontaneous report from a contactable physician via a sales representative.  A male patient of an unspecified age (reported as Age: 66, Unit: Unknown)  received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)and concomitant medications were not reported. It was reported that the patient experienced his whole arm was swollen and red, low grade fever on an unspecified date.  Outcome of the events were unknown.  Information on the batch number has been requested.
This spontaneous report was received from a registered nurse, regarding to a patient of an unknown age. The patient's concurrent, historical conditions and concomitant medications were not provided. On 10-AUG-2018 ,the patient received an expired dose (Expired vaccine used) of M-M-R II for prophylaxis (dosage, route of administration, anatomical site of injection were not provided), lot # M035388 and expiration date on 02-AUG-2018.  The vaccine was reconstituted with sterile diluent (DILUENT MRK INJ) for reconstitute the vaccine (dosage, route of administration, lot # and expiration date were not provided). The vaccine administrated had temperature excursions, the reporter said the vaccine was exposed to 9-25 (8.8) Celsius degrees for 13 minutes and 9-25 (9.3) Celsius degrees for 15 minutes. No adverse effects reported.
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  The Medical Staff and the Medical Squadron Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Market Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.  Note: this is one of the two patients who will defer a repeat dose and proceed to 2nd dose at 28 days
immed p/vax pt slouched over in chair in an unconscious states;pt assisted to floor to avoid injury & body began sz like motions;pt eyes rolled to back of head & nose & mouth became dusky purple in color;became stiff in a fetal position;
Patient said since he got the vaccine, he has been experiencing pain on his arm & get worse when he lift his arm up.
Patient received first dose of Moderna on 4/27/21 and second dose on 5/25/21, she received 0.25 mL booster Moderna on 11/12/21, approximately two weeks short of 6 month interval between second dose and booster. Patient tolerated vaccine well, she was informed that booster was administered earlier than the 6 months due date and she verbalized understanding.   She was monitored for 20 minutes and she had no questions or concerns.
At midnight, I had the expected symptoms - sore arm, slight headache, chills.  At 7 am the morning of 11th, I took the dog outside - felt very woozy, nauseous, but not enough to throw up, but then completely lost my eyesight.  Everything went "white" and I couldn't see anything.  I stumbled into the house and then fell and hit my head on the corner of the wall and a cabinet.  My eyesight immediately returned after I hit my face (cheek and eyebrow area), but then I had to run to the bathroom where I had diarrhea.  I couldn't get up or stand or walk without feeling dizzy and off, so my husband helped me get back to our bedroom.  I slept until 12;30 pm when I got up for some light lunch.  I returned to bed and slept until 4:30 pm.  Once I got up, I felt fine.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced VERTIGO (Vertigo). The patient was treated with ONDANSETRON at an unspecified dose and frequency and MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Severe sphincter of odi flare with excruciating pain for 3/4 hours the morning after the injection and 4 days of flu like symptoms including chills, nausea and diarrhea. First shot in the series was less severe and did not cause sphincter of odi flare.
Approximately 3 minutes after recieving the shot, the patient fainted for approximately 15 to 20 seconds while seated in the waiting area.  Patient reported feeling nauseous but did not vomit.  EMT was called to the scene and checked her pulseox was at 100 and pulse was at 60 approximately 13 minutes after shot injection.
fever; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #019B21A and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qd. At the time of the report, PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported.