chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given 4 injections today with the last injection of Yellow Fever given at 11:01 am. Hepatitis A and Yellow Fever were both given in the left arm.  Hepatitis A given in the left deltoid and Yellow Fever given subcutaneous in left upper arm. The other two vaccine given were in the right arm. Polio given subcutaneous in right upper arm and meningitis (Menactra) given in the right deltoid. At approximately 11:07 patient started itching left deltoid area.  Asked patient if she was feeling itchy and she stated just a little on her arm.  Had her show me her left arm and it was reddened from her itching the area; so hard to tell if red from itching or a reaction.  Applied an ice pack to the area.   Asked it she had any shortness of breath, difficulty breathing - patient stated no.  Shortly after this, she stated that she was feeling warm and not feeling quite right.  Had patient lie on table and again made sure she was not having difficulty breathing. Had patient show me her arm that had been itchy and there was diffuse redness all around the shot area. Patient began to having the shakes in her legs and arms and lower chin.  Her face was looking very flushed and bright red as well as her neck and upper chest. No hives.  Provider examined her.  She was having heart palpations but Blood Pressure was stable as well as blood sugars.  Provider called a code. Code Team came.  She was given 50 ml oral benadryl.  After code team left she was monitored and kept hydrated  until symptoms resolved which was approximately 45 minutes. We had patient hang around for a little while longer until provider felt it was ok for her to leave. Patient was instructed to take 10 mg Zyrtec once daily for the next 3 to 4 days. To call if any questions or concerns.    VIS was given prior to administration.   Site aseptically cleansed and Immunization(s) given per protocol.     For Medications I am Administering I have verified:  Patients immunization history - Epic, HM, Verbal and Immunization Registry Proper/ correct PATIENT  identifiers included) - Yes  Proper ROUTE of administration - Yes Proper DOSE as ordered by the provider - Yes Proper TIME (sequence/ age included) - Yes Proper DRUG as ordered by the provider - Yes
Joint pain behind left knee started 6/25/16. Joint pain moved to right knee, left thumb right hand, right thumb on 6/26/16. Also, on 6/26, she had rash across cheeks, burning eyes, swollen and sore throat.
Pronounced local reaction to injection site - swelling (5x 5 &1/2cm), redness, itching, pain beginning in pm of 4/17/18 with increasing sx on 4/18/18. Tx recommended: ice, ibuprofen, hydrocortisone cream, Benadryl. If increases in next 24, antibiotics would be recommended.
Left arm with about 4x7 cm induration, redness, Tx cold compresses, Tylenol/Ibuprofen PRN.
This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. The medical assistant reported that the patients were administered an unspecified number of improperly stored doses of oral, ROTATEQ (lot # K006960, expiration date: 19-FEB-2017; and lot # reported as: K017576, expiration date: 12-JUN-2016) oral liquid (frequency were not reported) on unspecified dates since 21-MAY-2015. No adverse effects reported. Concomitant medications were not reported. This is one of two reports from the same source. Additional information has been requested.
7/8/99 225PM began vomiting & shrill cry;phoned MD & child taken to ER;pt went into shock,transferred to ped ICU;coded 15min later 11:30PM;taken to surgery,all intestines were black;had malrotation (intussusception);7/9/99 sz;
Patient reported experiencing tingling in fingers and toes later in day after receiving first dose of SHINGRIX as well as streak of nerve pain down back. Self resolved within a week of receiving vaccine
Leg pain; Pain went to my back; Painful when walking; Felt week; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jul2021 as dose 2, single (Lot number: EW0198) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EW0196), administration date: 30Jun2021, when the patient was 47-year-old, for COVID-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset Sep2022, outcome "recovering", described as "Felt week"; PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Leg pain"; BACK PAIN (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Pain went to my back"; PAIN (non-serious) with onset Sep2022, outcome "not recovered", described as "Painful when walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, back pain, pain, asthenia.  Additional information: No fever. The weakness patient still had, but  feels better (its been 7 days).The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient was not tested COVID post vaccination. The patient did not have any known allergies. Treatment included auto-adjustable positive airway pressure (APAP) & Naproxen.
Diarrhea the following day after vaccination and still experiencing diarrhea on 8/17. Patient also reports fatigue.
My shot site is slightly raised, hard, with a red rash around it. Itches slightly.
12/14/2021 - Patient came to ER with c/o weakness, nausea, myalgias x 3-4 days. T- 102.2, P- 109, RR- 28, 93% on 4L NC. WBC 8.9, CRP 1.8.  Zosyn given Unasyn ordered. Covid + , Chest xray revealed groundglass consol. Decadron, Heparin, Remdesivir, Baricinib initiated. Monoclonal held due to oxygen use. 12/16 - Temp avg 98.5, O2- 2L saturating 95%. Patient suffered mechanical Fall overnight with no injury. WBC -11.9 trending up but back down by 12/17.  12/22 - Patient doing well. On room air, decreasing steroid, completed course of Remdesivir. Quarantine ends 12/23.  12/24 - Discharge to home with doxy and decadron taper and Eliquis x 1 month.
episode of jerky movement of arms & legs + - 2min while pt asleep assoc w/frothing @ mouth;
Admission Date: 8/25/2022 Discharge Date: Aug 26, 2022  PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1]   HOSPITAL COURSE:   59-year-old female with past medical history significant for atrial fibrillation, hypothyroidism, hypertension.  She presents emergency department 8/25 with several days of cough, shortness of breath and fatigue.  She tested positive for COVID.  She is hemodynamically stable initially however placed on 2 L of oxygen for support.  Chest x-ray was unremarkable.  She was started on Decadron.  By the following morning patient is feeling much better and is on room air.  Her symptoms were improved.  Discharged home in improved primary care condition to complete a course of Decadron and follow-up with primary care as needed.
stomach began hurting; not feeling like herself; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach began hurting) and FEELING ABNORMAL (not feeling like herself) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included CYCLOSPORINE, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), ALBUTEROL [SALBUTAMOL], ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN, BENZONATATE, CELECOXIB, DULOXETINE, GABAPENTIN and HYDRALAZINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach began hurting) and FEELING ABNORMAL (not feeling like herself). At the time of the report, ABDOMINAL PAIN UPPER (stomach began hurting) and FEELING ABNORMAL (not feeling like herself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drug information was not given.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: NNI FU- No new information
After both injections I have experienced cellulitis in my eyes; first in my left eye developing less than 24 hours after the injection and then cellulitis in my right eye developing about 3 days after the 2nd injection
CHEST PAIN, SHORTNESS OF BREATH, LOW GRADE FEVER AND HEADACHE
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of GARDASIL (lot # and expiry date unspecified) which were improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to GARDASIL. This is one of several reports from the same reporter (MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014262, MARRS #1503USA014263, MARRS # 1503USA014264 and MARRS # 1503USA014265). Additional information has been requested.
Bad headache, nausea - threw up numerous times until there was no more to throw up.  These conditions lasted for about 30 hours, followed by body aches and weakness.  Now feeling mostly better two days after receiving vaccine.
This spontaneous report as received from other health professional via a company representative refers to an approximately 60 year old female patient. The medical history and current conditions were unspecified. On an unknown date in January 2013 the patient was vaccinated with ZOSTAVAX dose 1 (route unspecified). Concomitant medications were not reported. On an unknown date sometime in January 2015, the patient was vaccinated with dose 2 of ZOSTAVAX. The patient did not experience any adverse reaction from the first or second dose of ZOSTAVAX. The patient did not seek any medical attention and no treatment was rendered. Additional information has been requested.
Rec'd Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine.  PT should have received Dtap, Polio, and Hep B vaccines, not the HIB.  At this time, no known symptoms of adverse reaction. Will continue to monitor.
Client received vaccine in drive thru clinic operation, while in observational area, EMS was on site, 10 minutes after vaccine was administered, pt experienced anaphylactic reaction including swelling of lips, tongue, and throat, 0.3mg epi , 125 mg solucortef, 50mg Benadryl administered by EMS. Pt transferred to local ER. Presented to ER with no swelling noted,  breathing unlabored, skin w/d/intact.
The day I received the vaccine I had a headache, mild arm soreness, and slight fatigue. These symptoms went away the next day. On day 10 post vaccination, a red rash developed on my left arm where I had been vaccinated. My arm was extremely sore this time. The next day I woke up with a severe rash all over my body. It was symmetrical, both of my hands/ elbows/thighs/ankles/and feet were covered in raised red bumps. The rash was extremely itchy. It continued to get worse for the next couple of days. After consulting with a doctor, I took a steroid dose pack and used a topical steroid cream to stop the rash from continuing to get worse. It eventually went away about a week and a half later.
Loss of smell; Lung infection; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 09Apr2021 (09:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN620F; Expiration date was not reported) on 19Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 24May2021, the patient had lung infection. The patient went to the doctor (physician's office visit), and was put on antibiotic (doxycycline 100 mg, by mouth twice daily) and hydrocodone every six hours as treatment for the lung infection. On 28May2021, the patient had loss of smell (could smell some things but not others). The outcome of the events was not recovered for loss of smell; and was unknown for lung infection.
tingling side of tongue and jaw and weird taste in mouth (metallic taste) starting at 0930.  Injection given at 0900.  Symptoms better after 45 minutes.  Vital signs stable.
skin infection; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 22-SEP-2015, patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from and was diagnosed with a skin infection. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of skin infection was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). The event of skin infection was considered to be disabling.
Swelling, fever, large area of redness, pain; returned to doctor, prescribed antibiotic and steroid for possible infection.
Injection site reactions, sick with ear infections, colds, upper respiratory infections, loss of words/actions. Autism.
SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 year old male. 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: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
I just got sick with COVID-19. I went to ER, they admitted me into the hospital gave me an infusion.
AFTER I HAD MY LAST DOSE OF ANTHRAX I'VE EXPERIMENTED CONSTANT HEADACHES, MUSCLE/JOINT PAIN, FATIGUE (FEELING TIRE WITHOUT REASON), SKIN ITCH, BACK PAIN, SHORT LOST OF MEMORY OR DISORIENTATION. IN TOTAL I'VE HAD 4 DOSES OF ANTHRAX BETWEEN 2003 AND 2006.
Baby has rash on both thighs. No fever, vomit or any other complications. Patient to follow up with Dr in 1 week.
This case was reported by a other health professional via call center representative and described the occurrence of localized itching in a 9-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number YA95S, expiry date 30th June 2019) for prophylaxis. On 23rd November 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 23rd November 2018, 30 min after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced localized itching, rash and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the localized itching, rash and hives were unknown. It was unknown if the reporter considered the localized itching, rash and hives to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by a physician assistant. The patient received FLUARIX QUADRIVALENT 2018-2019 season on the left arm. The patient experienced itching on her feet, and rash and hives on her arms, back, and legs. Reporter's Comments: The Physician's Assistant (PA) reported that the patient experienced itching on her feet, and rash and hives on her arms, back, and legs thirty minutes after the injection. The PA reported that the patient was treated with BENADRYL.
adminstered a dose of Menactra that was mixed with sterile water/ they have not heard from the parents about an issue; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was reconstituted incorrectly.  The patients past medical history, concomitant medication and family history were not provided.   On 23-Apr-2019, the patient received a first dose 0.5ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6204AA, expiry date 08-May-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique. It was reported that nurse adminstered a dose of Menactra that was mixed with sterile water and they have not heard from the parents about an issue.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Three hours of severe crying, irritability-alternated acetaminophen/ibuprofen and crying resolved.
Cough  Muscle or body aches  Congestion or running nose New loss of taste or smell
delayed cutaneous hypersensitivity reaction Narrative:  Notice rash approximately 7 days after 1st dose. Rash took 5 days to resolve.
Pharmacist called and stated that a patient received their 1st dose of MMR II on 9/28/2023 and then received their 2nd dose too early on 10/16/2023. Caller stated patient has not reported any symptoms. No additional AE/no PQC.; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-SEP-2023, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 16-OCT-2023, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse event was reported.
AFTER 10 MINUTES OF THE VACCINE, HE FELT HOT, TIGLING IN HANDS AND FEET. HE DRANK SOME WATER, THEN HE LAY OUT ON THE SOFA BED FOR 10 MINUTES. AFTER THAT,HE SIT UP, THEN HE THREW UP.  HE SAID THAT HE FELT BETTER TO LAY DOWN THAN SIT UP. WE STARTED TO CALL PARAMETIC. AS SOON AS PARAMETIC TEAM CAME, THEY CHECKED HIS VITAL SIGN , BLOOD PRESSURE. HE WAS OK, BUT THEY TOOK PT TO NEAR BY HOSPITAL TO MONITOR. PT WAS DISCHARGE FEW HOURS AFTER WITH ANTINAUSA MEDICATION. WE FOLLOWED UP WIHT PT , AND HE SAID HE WAS OK NOW.