chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Monday, right foot broke out and patient was not sure what it was.  Went to the pharmacist and they were not sure what it was either.  On Tuesday, went to the ER on Tuesday (ER) and they were not sure what it was either so just gave patient injection for pain and released them.  Patient kept trying to go to work, wore slipper on foot but could not stand pain.  On Friday went to Hospital and it was diagnosed as shingles. Hospitalized for 11-12 days.  Patient was in isolation since also had chickenpox on back.  An MRI was done in the hospital.  Patient had to file for disability since have not been able to work since 7/5; first could not go to work because sore were open and then after they healed could not go because of the pain. On 7/18 visit with primary for follow-up; filled up paperwork for disability. After hospitalization, visit with RA specialist had her stop weekly Norco injections and just restarted them last week. This is the doctor that prescribes Gabapentin, Norco injections and folic acid. On 7/25 visit with Pain Management doctor prescribes the hydrocodone/Norco and Tizanidine. He increased Gabapentin dose because patient could not take weekly Norco injections.  On 7/25 went to Dr, neurologist, who treated patient at hospital to follow-up on tremors that got worse. In hospital patient received Valacyclovir on a drip and then prescribed Valacyclovir 1 gram.   On 8/12, Dr did an EMG.  Visit with Dr on 8/15 and 8/19 because foot was still so bad that it felt like if walking on lump.  On 8/20 visit with Dr  (podiatrist) who specified it is just related to shingles.   On 8/22 had follow-up visit with Dr.  On 9/10, Dr told patient to go back on Norco injections.  On 9/16 visit with Dr and Dr for follow-up.  On 9/23 visit with Dr for back injection.  In terms of recovery, outbreak has healed but now dealing the pain. Patient is in so much pain that cannot put shoes to or drive to go back to work. She puts foot in a bucket of water to help ease the pain. Recovery at 40%.  In terms of recovery, outbreak has healed but now dealing the pain. Patient is in so much pain that cannot put shoes to or drive to go back to work. She puts foot in a bucket of water to help ease the pain. Recovery at 40%.   Patient had chickenpox when she was little.   She participated in shingles study in 90s; she was in the placebo group but received vaccine for free for participating.
17 erythematous macular-papular lesion with some vesicular formula-erythematous base-consistent with varicella.
Developed acute severe abdominal pain and found to have splenic infarct, splenic artery thrombosis, celiac artery stenosis on morning of 4/14/2021 on CT abd/pelvis with IV contrast and presented to ED for symptoms. Started on apixaban.
pt brought to ED from a nursing facility for increasing SOB; pt c/o fatigue; COVID pneumonia and respiratory failure with hypoxia; placed on O2, NRB 15L O2; started on remdesivir, steroids, antibiotics, lovenox; per pt's death certificate, pt died in the hospital from COVID pneumonia
Tongue and throat swelling, chest pain 1 1/2-2 hours after vaccine was given IV BENADRYL and PEPCID given in ER.
Temp of 104 degrees. Rapid heart rate, chest pain, headache. Was given Tylenol and Motrin in ER. Temp 101 at discharge.
body aches; chills; Pink eye; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Shingrix. In January 2023, 1 week after receiving Shingrix, the patient experienced general body pain, chills and pinkeye. On an unknown date, the outcome of the general body pain, chills and pinkeye were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, chills and pinkeye to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The reporter called and stated that patient received first dose of Shingrix. The reporter reported that about a week later started to experience pink eye, chills, and body aches. The reporter did not consent to follow up.
First CPVOD Pfizer on 1/22/2021, 2nd COVID Pfizer on 2/19/2021 Developed episodes of tachycardia starting 2/12/21. Seen by me (MD)  2/15. BW showed low TSH, otherwise NL. Labs repeated and TSH undetectible with high Total T3 and NL Free T$. TSH stimulating AB very high, suggesting new Graves disease/Hyperthyroidism. We have a NORMAL TSH on file from March 2020
About 10 minutes after first vaccination, patient complained of numbness/tingling of the mouth / lips.   Patient was offered diphenhydramine - patient reviewed side effect - diphenhydramine provided to patient.
I started to feel like I was catching a cold, possibly the fl. I had a small headache. I took a home COVID-19 test, it did come back positive. I called my doctor to let them know I tested positive for COVID-19, I was prescribed the Paxlovid. I started taking it immediately. I was feeling better within a day of taking the medication.
Vaccine received at 27 weeks 2 days pregnant. Baby's due date is 10/27/2018. This is my second pregnancy. I had this same vaccine during my first pregnancy with no reactions. I did receive the vaccine a few weeks later with pregnancy #1 around 32 weeks I believe. I have also had this vaccine when I was not pregnant previously with no reactions. I woke up 7/31/18 with body aches, chills, low grade fever 99.1 orally, fatigue, and overall just feeling miserable and flu like. I took Tylenol about every 4 hours and the symptoms subsided. These flu symptoms were gone the next day. However, I developed different symptoms later in the day. Later that same day 7/31/18 around 5pm I noticed I was increasing fatigued (more than the morning) and winded with very minimal activity. My heart rate would increase to about 130 and I was short of breath/winded with very light activity such as walking 15 feet at a very slow pace. I would have to stop and sit down and rest for a few mins and my heart rate would come down and I could start again. Activity such as doing a load of laundry or washing the dishes caused in increase in HR/SOB as well which was not the case prior even being pregnant. 8/1/18 the elevated heart rate and shortness of breath continued and prompted a trip to the ED. After multiple tests it was determined I had a likely inflammatory reaction to the Tdap vaccine. These symptoms finally subsided 8/12/2018. I was told to increase hydration and take it easy. If it would have persisted a beta blocker was the next step but I did not need that.
My arm where I received the vaccine started hurting really bad again yesterday, 8/8/21, lump came back, arm was itching. Woke up this morning and had huge red area and rash.
30 min after numbness mouth/lips, tingling feet, chest tight, sinus , ear , eyes felt right hurt . Took Benadryl . Went to bed .
Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose 2, Date: 01Apr2021 / Moderna, Dose 3, Date: 22May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22May2022 as dose 3 (booster), single (Lot number: 057m21a) for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: en6206) and on 01Apr2021 as dose 2, single (Lot number: er8732) for covid-19 immunisation. The patient's relevant medical history included: "mod kidney disease" (unspecified if ongoing), notes: Other Medical History: mod kidney disease; "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22May2022, outcome "unknown", described as "Pfizer, Dose 2, Date: 01Apr2021 / Moderna, Dose 3, Date: 22May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) Negative, notes: neg test on 15Apr2023; (17Apr2023) Positive, notes: pos covid test 17Apr2023. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (lot: 6k2844) from 07Apr2023 to 12Apr2023.
her arm hurt; Patient was injected they noticed some of the liquid running down her arm to her wrist; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Media Information (under the reference 00831417).  This case involves a 68 years old female patient whose arm hurt (vaccination site pain) and was injected they noticed some of the liquid running down her arm to her wrist (injection site extravasation) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had no other concomitant vaccines.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (once, 0.25 mL to 2 mL, total, lot UJ768AC and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 27-Oct-2021, the patient developed a non-serious arm hurt (vaccination site pain) and was injected they noticed some of the liquid running down her arm to her wrist (injection site extravasation) (unknown latency) following the administration of vaccine.  No laboratory data reported.  It was reported "Caller stated that she was administering vaccine to patient, there was either a failure on the syringe portion or the needle portion and when pushing plunger in, some of the liquid came out and was running down the patient's arm. the needle was placed on the syringe tightly and there was no problem when the air was pushed out of the syringe nor did she hear any sound like a leak but when the consumer was injected they noticed it running down her arm to her wrist and she states her arm hurt. Pharmacist would like a credit and gets it from VAXSERVE."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.
severe Left shoulder pain, weakness, paresthesia's, changes in temperature, skin sensitivity consistent with brachial neuritis
Patient is only 17 years old and received vaccination that is only approved for 18 years of age. At time of immunization and 15 minutes following, not symptoms besides sore arm. Patient instructed to monitor symptoms and call pharmacy and health care provider if anything develops.
Pt had a vasovagal reation w/ ionjection.  Pt was placed on cot.  Available vitals: HR 86-89, Sat 99-100% RA Pt stable and released from the vaccination site at 17:33.  Alert and Oriented
Hives; This is a spontaneous report from a contactable other hcp on behalf of physician .   A 6-month-old male patient received the 3rd dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose in the thigh on an unspecified date in Mar2019 for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took 2 doses of Prevnar 13 on unknown dates for immunisation. In Apr2019, the patient experienced hives with outcome of recovered in Apr2019. The event was described as follows: The mother reported that the patient started with hives, two days after receiving the injection. The hives lasted for about a week and then they were gone. The doctor would like to run a test to see if it may have been caused by the polysorbate. Patient received three vaccines total at that time. He received two in one thigh and one in the other thigh.  The information on the Lot / Batch number has been requested.
pressurized spray from the adjuvant vial hit him in the eye; pressurized spray from the adjuvant vial hit him in the eye; This case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a 25-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown.  Additional details were provided as follows: The patient was pharmacist and self-reported this case. The age at vaccination was not reported. The pharmacist reported that they were drawing up the Shingrix adjuvant for reconstitution, when a pressurized spray from the adjuvant vial hit him in the eye, as the needle was being removed from the adjuvant vial, which led to inadvertent exposure to vaccine, exposure via eye contact. The patient immediately rinse the eye and not experienced any side effects, at the time of reporting. The reporter did not consent to follow-up.
Peri-nasal rash < 24 hours after vaccine. Lasting more than one month.
First odd event was 15-day menstrual period that began around Dec. 8 and began again on Jan. 4 for six days. Right around Christmas she began faint wheezing (patient was non-verbal & cognitively impaired) and by Dec. 30 she was having difficulty swallowing  and breathing --  which sounded like it was from throat tightening or spasms.  She was also rapidly losing weight.   By late January she seemed very weak and was no longer able or willing to stand/support her weight (she normally could walk with assistance and support her weight) and by February was having a lot of difficulty sleeping because she seemed particularly uncomfortable lying down -- especially on her back and appeared to be very uncomfortable & restless most of the time. Always seemed to want to sit up and lean forward.  Swallowing liquids appeared to be painful ... she would cry briefly after swallowing liquids, but not food.  Intermittenly one or both feet would be purple & cold or become hot, red, puffy & painful.  Treatment consisted of changing to a pureed diet, increase dosage of omeprazole (40 mg. 2x day for 4 wks following a Jan. 12 EGD) and eventual placement of a g-tube on March 30 because she was losing so much weight and unable to eat more than 1/3-1/2 cup of food at meals; and using a cool-mist humidifier to relieve throat spasm (if that's what it was) episodes.   Also took mag citrate chews as needed to alleviate constipation.   Her symptoms did not improve, she was finally admitted to the hospital on April. 6 from the emergency department where she was taken for difficulty breathing. Arterial blood gas tests showed increased CO2/bicarbonate levels & elevated white count; pulmonologist  described her as failing to thrive, her diaphragm was failing and our choice was to either place her on a ventilator or take her home w/Hospice care. There was a consensus from critical care staff that she would not come off the ventilator so we took her home w/Hospice and she died on April 12.   The cause of death on the death certificate was listed as aspiration pneumonia ... but that was never mentioned to us while she was hospitalized. Pulmonologist said he thought the increased white count was from the UTI, but she had been on cefpodoxime for that for more than a week already.   Patient had zero previous problems with difficulty swallowing or breathing.   When she died she was being treated for a UTI with cefpodoxime; and had been treated for another UTI in early Feb. with 5-days of IV levaquin.
11.30 PM chills lasted one hour , treated w/Tylenol  1:30 AM racing heart, 110 bpm, lasted one hour , treated with Tylenol and controlled breathing Following day headache and no energy
loss of consciousness approx 5 min post vaccination.  pt was standing when consciousness lost.  no seizure activity, no cyanosis, no post ictal confusion
29JUN94 pt recvd vax & h as achiness & t103; referred to MD 5JUL94 tc from pt states is hospitalized-dicharged on 8JUL; 22JUL94 also had nausea, vomiting; now c/o weakness;
pt exp night sweats /low grade fever followed by vomiting; overnight in duration, resolved by am
Initial misuse report received on 25 October 2013 from a health care professional. A 54-year-old female adult whose medical history and concomitant medications were not reported, received at unspecified site dose of YF-VAX (lot number UH668AA, expiry date unknown and site of vaccination left upper arm SQ), received at intramuscular dose above YF site of TYPHIM VI (lot number J0501-1, expiry date unknown and site of vaccination left arm SQ) and received at unspecified site dose of BOOSTRIX (lot number AC52B110CA, expiry date unknown and site of vaccination right upper arm) on 18 October 2013, IM. Nurse reported that a patient, a week after she received the vaccine, developed redness and induration, at the injection site of the YF-VAX, 5cm area, getting bigger. No testing, treatment. No reaction was reported. List of documents held by sender: none.
shingles; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 10:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), endometriosis, anxiety, depression,  and chickenpox. The patient previously received codeine (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), trazodone hydrochloride (DEPRAX), cetirizine hydrochloride (ZYRTEC), lorazepam (MANUFACTURER UNKNOWN) and dicycloverine hydrochloride (BENTYL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 08:00 the patient was diagnosed with a small case of shingles, was wrapped around her right rib cage. The patient did have chicken pox as a child so the vaccine did not gave her shingles but it may have triggered the outbreak. Therapeutic measures were taken as a result of the event which included Valtrex 3 times  for 7 days. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1/8/21When I stood up a  felt a slight tingle in my left arm and leg. My speech felt slurred for abut 10 minutes soreness in left arm 1/9/21 woke with headache soreness in arm 101 fever later in evening arm warm to touch 1/10/21 arm stiffness, body ache 1/11/21 arm stiffness, red, hot to touch 1/12/21 arm red and hot to touch 1/13/21 arm red and hot to touch
Soreness in arm at injection site, lasting over 2 weeks and gradually increasing in intensity and the area affected.
4-5 days for aches and flu like symptoms before severe rash developed from center of chest around left side to back center. Dr Rx NEURONTIN and VALTREX.
Symptom first started with soreness in the left tonsil, then swelling and now the pain has moved to my ear canal.  This has been going on for 3 days and I have to take Tylenol and provide relief so I can sleep.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.12 years.  Concomitant products were not provided. Treatment medications were not reported.  On 06-Apr-2021, the vaccine with batch number 044B21A was moved to fridge. On 15-Apr-2021, 18 vials were moved to the clinic. On 15-Apr-2021 at 9 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-May-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
Fever (102.7), chills, headache (did not go away with Tylenol or Ibuprofen), body aches.