chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received moderna vaccine on 2/5/21, 3/9/21, and 12/13/21. Presented to ER on 7/26/22. Found to be COVID positive 8/5/22. She was initially admitted to HospitalF on 7/26 with confusion, UTI, and hyperglycemia. This was associated with decreased appetite and reported functional decline with worsening dementia over the past few months. Urine culture was positive for pan-susceptible E. Coli. She completed a course of Ceftriaxone. Throughout her admission, blood glucose was labile; significantly elevated, punctuated by periods of lows. Patient was pending discharge to facility but pre-placement COVID screening resulted as positive on 8/5, delaying transfer. In the morning of 8/7, her blood glucose was noted to be significantly elevated and chemistry panel was obtained. This demonstrated anion gap of 31, CO2 of 7 and blood glucose of 633. She had a large amount of acetone in her serum. She was noted to be encephalopathic. Findings consistent with DKA. She was transferred to from 5100 to ICU with intensivist consultation.    Kept NPO, started broad-spectrum antibiotics for possible sepsis, sepsis protocol initiated, chest x-ray showed no infiltrate on 08/07, UA did not show evidence of infection on 08/07, blood cultures and urine culture are negative so far.   Patient is out of DKA on 08/08/2022, bridged with long-acting, but patient is not eating even though awake, also remained noncommunicative later on, patient has severe dementia history and poor functional status, daughter and son continued to wish against tube feeding, goal of care discussion initiated with family and family members opted for hospice care.  Patient will be discharged to facility with the hospice care. Discharged on 8/10/22. Passed away on 8/12/22
PATIENT REPORTED CHILLS BEGINNING DURING NIGHT 4/26/19, THEN DEVELOPED FEVER 100.2, BODY ACHES.  PATIENT ADVISED TO CONTACT PCP FOR TREATMENT.
Itching; Whelps in front and back torso; Swollen places (some as big as Silver Dollars); Whelps down right arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), URTICARIA (Whelps in front and back torso), SWELLING (Swollen places (some as big as Silver Dollars)) and VACCINATION SITE URTICARIA (Whelps down right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRURITUS (Itching), URTICARIA (Whelps in front and back torso), SWELLING (Swollen places (some as big as Silver Dollars)) and VACCINATION SITE URTICARIA (Whelps down right arm). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. On 03-Apr-2021, PRURITUS (Itching), URTICARIA (Whelps in front and back torso), SWELLING (Swollen places (some as big as Silver Dollars)) and VACCINATION SITE URTICARIA (Whelps down right arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.
some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes and on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes. (Incorrect product storage). There was previous temperature excursion however it was not reported.
Calling about the Pfizer BioNTech Covid 19 vaccine. She started taking Paxlovid; Calling about the Pfizer BioNTech Covid 19 vaccine. She started taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 99-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing), notes: She does have a pacemaker and takes high blood pressure medication.; "high blood pressure" (unspecified if ongoing), notes: She does have a pacemaker and takes high blood pressure medication. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Calling about the Pfizer BioNTech Covid 19 vaccine. She started taking Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (reported as several years ago), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, immediately after receiving the vaccine, the patient experienced menstrual changes. The outcome of menstrual changes was unknown. The relatedness between menstrual changes and GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA008724.
pt recv vax;legs felt like lead; could barely move; arms numb; exp chills & fever & fever blister,broke out on face; very unsteady to hosp; was given a sedative;
I developed a fever of 101 that night. Which continued throughout the entire night. I had a mild cough and trouble breathing so it caused an asthma attack. Nausea for about 72 hrs. after does 2. I have abdominal pain and joint pain, which caused me to be bed ridden. I also had diarrhea. All of these symptoms with dose 4.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored LIQUID PEDVAXHIB, lot number L004740, expiration date 16-NOV-2017 (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
From an initial report received on 01/12/01, it was reported that a 41 year old female was given Fluzone SV '00 -'01 vaccine on 01/09/01. patient reportedly "developed edema and joint pain- elbow, wrists and ankles and fingers, also neck pain the evening after vaccination still persist". From additional correspondence received on 02/16/01, additional patient, vaccine, responsible physician and vaccine administrator information was provided.
Fatigue, fever, headache, nausea, vertigo and chills. Tx'd with bedrest, fluids, advil and/or tylenol. Pt returned to full activities 10/21/99. Have had no further calls from pt.
Information was received from a pharmacist referring to 9 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates between 27-SEP-2016 and 10-OCT-2016, the patients were inadvertently administered a dose of improperly stored ZOSTAVAX (8 doses of lot # L046896, expiration date 23-FEB-2017; 1 dose of M032139, expiration date 02-OCT-2016; dose and route were unknown). The vaccines were stored under the temperature 6 Celsius degree for 432 hours. There was no previous temperature excursion. No digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Within a day of receiving the vaccine, patient developed swelling of his right arm/forearm/hand, developed a rash and swelling across his whole shoulder from the shoulder down to his hand, some numbness in the arm. Patient also experienced fatigue, fever, and chills for 3 days.   After 3 days, the rash and swelling went down and the patient started to feel better.
SOB, visual disturbances, hand numbness and weakness. PATIENT REQUESTED SOMEONE COME SPEAK WITH HER DURING THE VACCINATION TO DISTRACT HER BECAUSE SHE DOES NOT LIKE IMMUNIZATIONS. I ASKED SOMEONE TO ACCOMPANY THE PATIENT WHILE I ADMINISTER VACCINE. UPON INJECTION, PATIENT JUMPED AND IMMEDIATELY NOTED SHORTNESS OF BREATH, VISUAL DISTURBANCES, AND HAND NUMBNESS/WEAKNESS. THERE WAS A SMALL DROP OF BLOOD THAT RAN DOWN HER ARM ABOUT 1/2 INCH BEFORE I STOPPED THE BLEEDING WITH A COTTON BALL AND COVERED IT WITH A BANDAGE. I INSTRUCTED HER TO BREATH DEEPLY, SLOWLY, AND EVENLY AND HER BREATHING SEEMED TO BE IMPROVING. SHE CONTINUED TO NOTE HAND NUMBNESS AND WEAKNESS. SHE THEN ACCEPTED OUR INVATIATION TO ESCORT HER TO THE EMERGENCY ROOM. PATIENT REMAIND ALERT AND TALKATIVE AS I ASKED HOW HER BREATHING WAS AND IF SHE HAS HAD ANY REACTION LIKE THIS TO ANY OTHER VACCINE, TO WHICH SHE REPLIED SHE HAD NOT; THAT SHE MAY HAVE REACTED TO THIS BECAUSE THIS IS A DIFFERENT MEDICINE THAN SHE'S HAD IN THE PAST. UPON LEAVING HER AT THE EMERGENCY ROOM, I ASKED HOW HER BREATHING WAS AND IT SEEMED TO HAVE IMPROVED BUT HER HAND WAS STILL NUMB. I ASKED EHR TO STOP BY THE PHARMACY BEFORE LEAVING THE BUILDING SO I KNEW HOW SHE WAS DOING. SHE STOPPED BY AT 10:48AM TO EXPLAIN THAT THE DR. IS HAVING HER MONITOR FOR ANY LOCAL REACTION AND ANAPHYLAXIS TYPE REACTION AND TO REPORT TO ER RIGHT AWAY IF SHE NOTICES ANY SWELLING OF THE MOUTH/THROAT. HER NUMBNESS SEEMED TO BE SUBSIDED AND LOCALIZED MORE TO THE UPPER ARM AREA ABOVE THE ELBOW. SHE WAS GRIPPING HER KEYS IN HER LEFT HAND WITH HER POINTER FINGER POKED THROUGH THE RING ALL THE WAY DOWN TO THE KNUCKLE. SHE WAS STILL INTERESTED IN THE SECOND SHOT BECAUSE SHE HAS FAMILY MEMBERS WHO HAVE HAD SHINGLES AND DOES NOT WANT THAT.
Hives behinnd left knee, upper calf and thigh. 9/29/2011-Hives over buttocks and right leg. Denies Resp or GI issues. Took Claritin.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment details was not reported by the reporter.
approximately 6 hrs post injection, started to feel general malaise. 12 hours post injection: unable to move left arm due to pain and no strength, rigors, fever 101F. Throughout the night fever reached 101.9F, shaking chills continued. Day 1 after injection: fever persisted 100-101.6, chills and I slept all day, left arm very painful.  Day 2: low grade fever 99-100F, left arm less sore.    Day 3: afebrile, left arm less sore, general malaise.  Day 4: no problems.  I took no medications during this time.
headache; feeling tired; feeling hot; sore arm; feeling hot and cold; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced headache, fatigue, feeling hot, pain in arm and feeling cold. On an unknown date, the outcome of the headache, fatigue, feeling hot, pain in arm and feeling cold were recovered/resolved.   It was unknown if the reporter considered the headache, fatigue, feeling hot, pain in arm and feeling cold to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix in the left arm.  Later on that same night of vaccionaton, the patient reported a sore arm, feeling hot and cold, feeling tired, and headache.  All of these symptoms lasted for one day and resolved. The reporter did not consent to follow-up.
Fever, vomiting, chills, diarrhea, headache, muscle weakness, rash at nape of neck and behind right ear, puffy eyelids, and tongue thickness. Chest congestion and mucous cough. Friday night through Sunday afternoon. Headache continued until Monday. Cough continues to today, Sept. 22nd Thursday afternoon.
Rash on neck, chest, arm. Treatment of Benadryl by mouth. Refused to go to emergency room
Redness, swelling at and near the injection site, patient reports itching, pain & pain radiating down the arm to forearms. Fever was also initially reported but has subsided, body aches were also reported. At this time, patient has redness & swelling & pain....patient was instructed to do soft compresses around the site & take anti-inflammatory as directed by MD
Woke up Sunday morning with vertigo.  The room kept spinning the whole day with nausea and  vomiting. Took Meclizine.  Could not stand or eat.  Monday still extremely tired could not hold my head up and still dizzy but room was not spinning. Tuesday a little better than Monday.  Wed, Thur and Friday was able to function tired easily and was afraid to drive with occasional dizziness.
PATIENT STATES THAT THE DAY OF THE VACCINATION HER ARM WAS ITCHY AT THE SITE OF INJECTION, THEN IT STOPPED THE NEXT DAY, BUT THEN TWO DAYS AFTER THE VACCINATION IT RETURNED AND THE WHOLE ARM WAS ITCHY. THERE WAS NO SWELLING THOUGH.
A consumer report has been received. The report concerns a 4 year old male patient. No relevant history or concomitant medications reported. The patient received Nasal FLUENZ, once/single administration on an unknown date. The patient experienced mild fever 38/5 degrees. Therapy was an antipyretic drug. The patient recovered from the event of mild fever 38.5 degrees on an unspecified date. The report was considered to be non-serious by the company physician.
This patient presented with red raised, blotchy, hives,without pruritis on abdomen, back, arms, and face on 02/09. Seen in the ER on 02/10 in the AM. Ordered Benadryl. Improving as of 02/12, started fading 02/09 from face and back.
Heart rate increase to 150 ans over abut 17 hours after the vaccination. I was admitted to hospital as they ran tests.
When I woken up the next morning at 11:33AM - I Could not see straight, dizzy, stiff neck (when moved eyes up and down the picture bounced vertical; when I move eye left to right the picture bounced horizontal; looking straight could not focus at all enough to walk, drive, or even read anything much less see straight); also typical fever and horrific aches/pain. Today I have fever/aches; not perfect vision but enough to function; Numb finger tips and a few other oddities.
Fainted within minutes of vaccines shot, then shivering, headache, chest tightness puffy face, fatigue, dry throat, strange sensation in tongue -> ER -> Epinephrine Blood pressure down to 86/33. Still very weak with fatigue 4 day course of prednisone. Immediate improvement after epinephrine.
Around 2 hrs. after receiving 2nd dose. I felt nauseas and started having diarrhea. Vomiting 7 hrs after inital dose. Off and on vomiting for around 12hrs. Chills and aches during this time. Today is Saturday and still have diarrhea. (completely loose stools) almost like peeing out of my rectum.
Pt reports vaccine administration more superiorly in the shoulder than expected. Had immediate pain in the shoulder and approx 2 weeks later developed decreased ROM and pulling sensation in the shoulder
Immediate soreness at injection site, chills, and lethargy.. Vomiting and headache then 4 days later
Circular Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Circular Rash) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), FAMOTIDINE (PEPCID AC) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (Circular Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, RASH (Circular Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was given steroid for treatment. Patient also took Benadryl on her own for treatment.
First episode occurred appox 2 weeks after vaccination.  Started feeling warm and lightheaded, followed by severe pins and needles feeling over face and head, followed by pins and needles over most of body.  I thought I might be having a stroke or something, so I called to a fellow worker to tell them I didn't feel well, and sat down and talked.  Whole face felt strangely numb and tingly.  Severe feeling reduced after a few minutes, and I felt better after about 15 minutes.  I did not connect this with the vaccine at first.  A similar, less severe episode happened approx a week after this.  Since this happened, I have had on and off tingling, sometimes pretty severe, over my whole body.  Sometimes it is only in my hands and arms, other times my face, legs, etc.  Sometimes it feels like it is all over my body.  It is most apparent when I am sitting still working at a computer, reading, watching TV, etc.
Severe chills; Throat pain; Fever over 102 degrees; Muscle and bone pain that feels like my bones are trying to escape my body; Muscle and bone pain that feels like my bones are trying to escape my body; Headache/migraine; Headache/migraine; Frequent and urgent urination; Frequent and urgent urination; Left ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 17:15 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Covid prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 05:15 PM, Anatomical Location :  Arm Left), administration date: 31Aug2021, when the patient was 41 years old, for COVID-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Severe chills"; OROPHARYNGEAL PAIN (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Throat pain"; PYREXIA (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Fever over 102 degrees"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Muscle and bone pain that feels like my bones are trying to escape my body"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Headache/migraine"; MICTURITION URGENCY (non-serious), POLLAKIURIA (non-serious) all with onset 22Sep2021 02:00, outcome "not recovered" and all described as "Frequent and urgent urination"; EAR PAIN (non-serious) with onset 22Sep2021 02:00, outcome "not recovered", described as "Left ear pain". The events "severe chills", "throat pain", "fever over 102 degrees", "muscle and bone pain that feels like my bones are trying to escape my body", "muscle and bone pain that feels like my bones are trying to escape my body", "headache/migraine", "frequent and urgent urination", "frequent and urgent urination" and "left ear pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, oropharyngeal pain, pyrexia, bone pain, myalgia, headache, migraine, micturition urgency, pollakiuria, ear pain.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 with Nasal Swab test on 19Sep2021 and result was negative. Device Date reported as 22Sep2021.  Follow-up attempts completed. No further information is expected.
Case number PHEH2012US016632 is an initial spontaneous report received from a nurse on 22 Aug 2012: This report refers to an 11-year-old male child. He was given only the CYW-135 liquid component of MENVEO (batch number: M10075) intramuscularly on 22 Aug 2012. No other adverse reaction was reported following this administration error.
Broke out in hives 10 days after booster, red, hot, itching and raised skin whenever touched.  Pressure in chest like I swallowed a golf ball. Went to family doctor, prescribed prednisone for 9 days, Pepcid for 5 days, and Zyrtec for 10 days.  Prednisone helps while taking it, I still have hives and itching. Pressure in chest is gone. I hope it stays gone after I am Done with meds. I am doing a follow up visit with doctor and possibly seeing an specialist.
My husband reported feeling run down and achy on Tuesday morning and again on Tuesday night while working in NYC - this was followed by a cardiac event which required EMS and transport to the emergency room where my husband died.
Metallic taste in mouth, difficulty swallowing, burning in throat, nausea, lightheaded, headache, ringing in ears, heart racing.
Information has been received from a physician concerning a 25 year old female who on 21-JAN-2008 was vaccinated with her third dose of GARDASIL.  About two hours after receiving the vaccine, on 21-JAN-2008, the patient developed itching, an then not too much later, the patient experienced welts.  The patient took Benadryl and developed hives.  The patient was given epi pens and steroids and was sent to her OB/GYN's office who had given her Zyrtec, but the patient's problems persisted.  Additional information has been requested.
Janssen COVID-19 Vaccine EUA  Vaccine received around 11:30 am.  Started feeling chills around 6 pm; took temperature later and verified fever (101.6).