chrisvoncsefalvay/vaers-outcomes huggingface dataset:
from 5/25/21 note:   32 y.o. male with a history of DVT (left leg; on Xarelto), recurrent PE, EtOH abuse, anxiety, and depression presents to the emergency department complaining of right leg pain since the last two days. He reports to receiving his Moderna COVID-19 vaccination three days ago. Thereafter, he noticed his leg pain to occurs. He also notes to intermittent pleuritic chest pain, but not currently. He notes that his leg is not as swollen compared to his previous DVT. He has full sensation and motor control of his digits. He admits to dizziness. He denies changes in breathing, abdominal pain, recent surgeries, recent travels, recent hospitalizations, or family history of blood clots.   History is from the patient         Old records reviewed. Last ED visit on 3/2/21 for pleuritic chest pain. Recent hospitalization 2/8 to 2/9 for pulmonary embolism in the setting of Xarelto non-compliance.   US LLE Dplx (9/26/2020) DVT in the left popliteal, posterior tibial, peroneal and anterior tibial veins.   US LLE Dplx (2/8/21) Nonocclusive thrombus in the left popliteal and posterior tibial veins.   US RLE Dplx (5/25/21; today) DVT in the right femoral and popliteal veins.  from 5/27/21 note: Patient is a 32 y.o. male with history of EtOH abuse and recurrent DVT/PE known to be noncompliant with Xarelto presenting to the ED with altered mental status.  Of note patient was discharged from the hospital this afternoon where he was treated for DVT with heparin, previously on Xarelto but due to noncompliance was discharged with plan for Lovenox.  Patient is alert and oriented x3, however intermittently not responding appropriately to questions and does not appear to be the best historian.  Per EMS patient was found down, unresponsive in a bush.  Patient admits that when he left hospital he went to gas station and drank "18 ounces of wine."  EMS states when they arrived to scene patient had unsteady gait, frequent falls, no signs of significant head trauma.  Patient was tachycardic in route and noted to be hypoxic in route.  Patient currently complaining of mild headache but denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, back pain or any further symptoms once again believe patient to be a poor historian.
Mother called on-call nurse at 8:44 PM on 8/5/15 stating pt got Hep A in office and now has baseball size knot on back and whelps on face. No local reaction at injection site. Pt was otherwise fine.
Evening of 12-24-14 feeling sick , body chills, aching then hot diarrhea, nauseated, no vomiting. Noted arm is tender, red and swollen around area of infection. No itching. Taking BENADRYL and TYLENOL. Type 2 diabetic. No appetite. Able to control blood sugar. Had flu shot in Oct.
Within 8 hours my hot flashes from menopause had returned with a vengeance, night sweats, fever 100-103, up to 104, chills. Now just over 5 weeks later, this is all still present but including a 19 pound weight loss. But the daytime hot flashes have subsided, it's now severe night sweats (I have to change clothing and bed clothes at least twice during the night, completely soaked). The fever can be reduced with ibuprofen but definitely returns after the ibuprofen wears off. The fever doesn't start each day until shortly after noon. The mornings are the only time I feel normal. Also, less notable, I can no longer tolerate the taste of coffee. Also my desire for the taste for sugar has greatly diminished (have reduced the amount of sugar in a a gallon of iced tea by half).
Headache; Nausea; Chills/hot flashes; Pleurisy; Extreme fatigue; Considered going to ER because I was in such bad shape, but was too exhausted and I'll to get myself there. Felt better after 3 days. Extreme symptoms stopped after 35 hours.
3-20-09: Tdap left deltoid, 3-22-09: arm sore, fatigue, 3-23-09: pain in arm with movement swollen left axillary lymph node, tender to touch, 3-24-09: pain worse, swelling worse, 3-25-09: pain worse, swelling worse, CBC test results pending
On 2/22/03, breakout with chickenpox. All pox crusted by 2/28/03. At worst peak, counted over 240 pox all over body, including her scalp, ears, rectal area, under the tongue and in the mouth and under eyelids. Eye became very red and required ophthalmologist visit and viral treatment. Other treatment for chickenpox included Tylenol, Benadryl, oatmeal baths and calamine lotion. There is no lot number on the vaccine record for this vaccine or any of the others she received from this office.
Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion.  Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012404: US-009507513-1707USA012404: US-009507513-1707USA012404:
Cellulitis (L) arm and generalized rash patient given antibiotic - KEFLEX 500mg 1 QID x 7 days.
Patient was given MMR in office without problem.  Within 48 hours he developed a severe nonpurulent conjunctivitis and cough.  He was hospitalized for a left sided pneumonia and required intubation and ventlation for several days.  All cultures were negative. He was eventual discharged and had a full recovery. Child also had tachypnea and short of breath.  Nurse follow up on 09/02/04 states: "fever; atelectasis; reactive airway; tachypnea; respiratory arrest."
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced mild chickenpox with approximately 20-30 lesions.
Patient received Janssen Lot # 1808980, expiration 6/20/2021 at 1353 in the left arm sitting in a chair. At 1354 Client stated ? I just feel a little dizzy like I?m floating.?  instructed client to lie down in clinic room. Vitals taken: 1356: BP 11/79, HR 110, SpO2 97%, RR 18. Client Alert and Oriented x4. Client has no known allergies, no known prior history of vaccine reactions. History of anxiety, Migraines, and ?high heart rate? (per client). At 1401 client reported ?I feel good, I feel normal.? While still lying supine. Vitals? BP 110/90, HR 104, SpO2 97%, RR 16. Skin dry, color normal for Ethnicity, no skin color changes noted. At 1404  instructed client to sit up. Client stated ?I feel fine? in sitting position. Vitals: BP 120/88, HR 111, SpO2 98%, RR 16. At 1410 Client stood up, stated again ?I feel fine.? Alert and Oriented x4, denied dizziness or nausea. Vitals: BP 120/70, HR 110, SpO2 98%, RR 16. PHN?s educated client related to need to lay down before shots. Reviewed s/s allergic reactions, when to see PMD. At 1415 client walked off with steady gait, exited building, stated ?felt normal.?
Sore left arm; fatigue; Dose Number: 3; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FF8841), via an unspecified route of administration in Left arm, on 01Nov2021 10:15 (at the age of 31-year-old), DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medication history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration, on 02Feb2021, DOSE 1, SINGLE for COVID-19 immunisation and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration, on 23Feb2021, DOSE 2, SINGLE for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Nov2021 10:15 the patient received third dose and at 18:00 the patient experienced sore left arm and fatigue. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Patient had swelling at the injection site and all down her arm and hand.  The swelling was painful and she could not get her wedding ring on her fingers.
Pt had local reaction to DTaP right deltoid. Red, swollen, and hot to touch.
Diagnosed with cellulitis of left lower extremity  by immediate care clinic 1/8/23 (provider note: large erythematous area noted to left anterior thigh. Warmth noted with palpation, erythema spreading medially with pain on palpation), prescribed Keflex 165mg  four times a day for 10 days.
22JUL93 mom of pt called clinic to notify of poss reaction to immun; pt recvd vax 22JUL93; mom states pt crying, hot to touch & restless 6PM; rt cheek & rt eye red & swollen; also rash lasted 1 hr; Entire face & eyes red & swollen rash;
Brain fog Pain in every site of a previously broken bone, precisely as it felt 3-4 weeks after the break, simultaneously  Joint pain (soft tissue)
About 4 weeks from the date of vaccination I became ill for about 3 weeks. Fever at night, cough, chest and sinus congestion, severe headache. In the last week I notice a new vein appeared just proximal to the glans penis that matches exactly the description of lymphangiosclerosis. It has been about a month and the cord-like vein has not gone away and is uncomfortable during sexual activity. Additionally, the strength and size of erection has lessened and I do not wake up in the AM with erection as much or as strong as previous to the pfizer covid shot. My libido remains unchanged and strong as ever.
Sore left arm (upper portion); This is a spontaneous report received from a contactable consumer. The patient was 41-year-old female consumer. The patient received first dose of BNT162B2 (BNT162B2, Solution for injection, LOT: EL3248) through an unspecified route in left arm as a single dose on 03Mar2021, 09:45 for COVID-19 immunization (age at vaccination: 41-year-old). The patient was not pregnant at the time of vaccination. The medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient had not received any other medication within 2 weeks of vaccination. On 03Mar2021, the patient had Sore left arm (upper portion). The outcome of the event was reported as recovering.  No follow-up attempts are needed. No further information is expected.
hearing sounds in his ear that sound "like water falling"; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 16Feb2021 (at the age of: 78-years-old) as dose 2, single for COVID-19 immunization. Medical history included earaches (needing eardrops for wax build-up), COVID-19 from Mar2020 to an unknown date, pneumonia. It was reported that that the patient had COVID back in 2020 and COVID pneumonia he had cleared his self of that but when it came time for him to go to take his semi annual physical, he saw his doctor and he complained of having ear aches and she recommend some ear drops and he put it in and it worked a little bit. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration on 27Jan2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced hearing sounds in his ear that sound "like water falling". It was reported that the patient got the second dose and everything was going okay then last week he got in the bed and all of a sudden he started feeling little tingling in his ears. He wondered this could be something that the organization had received as a complaint of ear effects or if he might have a cold in his ear or water in his ear but he hears tingling right now. He just thought it may have been coming from the radiator then it was just in his head and still ongoing. It has stayed about the same, sometimes it will be a little lower and he will think it is going away then it comes back. It sounds like water falling. He does not report any headache, fever, chills, or anything. His medical history includes problems with earaches, needing eardrops for wax build-up, and he also had Covid19 back in Mar2020. He stated may be the antibodies are acting up and causing problems. He did have a problem with his ears. No further information provided. But lately last week he does not know whether he has a cold, they have had a lot of cold weather or if he had water in it or if it is a problem with the side effect. He had not had any other side effect, no swelling or nothing so he wanted to see if they had heard any other complaints or reports about this. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
25 itching continues and is spreading some.  There is no visible rash. 12:49 itching is improving. Pt is allowed to leave she is going home.  SHe will call someone to come pick her up. ,Notice tingling in right hand/ warm feeling and blotchiness of skin no Monitoring at vaccine site,Prescription medication
Vaccine-Drug interaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Vaccine-Drug interaction) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: STEROIDS (Patient mentioned that he has been taking steroids for the past week and today is the last day.).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DRUG INTERACTION (Vaccine-Drug interaction). At the time of the report, DRUG INTERACTION (Vaccine-Drug interaction) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Extreme headaches, nausea, vomiting, chills, fever, muscle aches and joint pain Symptoms started at 11 am on 4/26 and are ongoing into 4/27, treatment with Acetaminophen and trying to rehydrate
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with COVID-19 or tested Positive for COVID-19.     On 23-Sep-2022 at 3:19 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 3:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant medication was provided. On an unknown date, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.
Patient came into the pharmacy yesterday 10/2/18 to discuss her reaction to the arm. Pharmacist on site suggested a treatment for her with BENADRYL. Spoke to both mom and patient today and verified just local reaction of bumps and it started the following morning 9/29 when the patient woke up. Patient mentioned it spread but has stopped as of yesterday.
I was fine except for soreness in the arm and a mild headache  from the time I got the vaccine (Wednesday 1:20 p.m.) through the evening, but woke up (Thursday morning about 6:00) very sick .  I had a worse headache, extreme tiredness, nausea , vomiting (dry heaves as I  couldn?t eat or drink the whole time), fever and chills.  The bouts of vomiting fever and chills came in three through the day.  I felt extremely unwell the whole time and just kept reminding myself that it would be over soon, but it lasted throughout Thursday.  I fell asleep around 5:00 p..m. Thursday afternoon and woke up around midnight feeling that the symptoms had passed.  Now it?s Friday morning (5:30 a.m.) and I feel completely well again.
The patient experienced a temperature of 101.4F within 24 hours after receiving the vaccinations. The patient's temperature was still elevated 48 hours later.
Temp of 103, vomiting, pain at injection site (L) arm, swelling at injection site in (L) arm.
developed COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (developed COVID) in a patient of an unknown age and gender 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 COVID-19 (developed COVID). At the time of the report, COVID-19 (developed COVID) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (developed COVID) to be not applicable.    No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up appended :- AE update On 14-Jul-2021: Non-Significant Follow Up- (Reporter updated as Pharmacist and HCP as yes)
patient has come to get the second dose of Shingrix, however, her first dose was 7 months ago/late dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 7 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has come to get the second dose of Shingrix, however, her first dose was 7 months ago/late dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jul-2023 The health care professional (pharmacist) called on the day of reporting stating the patient had come to get the second dose of Shingrix. No further information was known. Minimal amount of information was obtained to file adverse event. The adverse event filed after call disconnected. The consent was not asked. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
I started feeling achy in my body around 5pm and the symptoms got worse from there. The ache was so strong that I took two Tylenol Extra Strength before going to bed. That night, I felt feverish and chills. I ended up putting several blankets on, even though it was a warm evening. I experienced sleeplessness and nausea throughout the night. My appetite, which is usually quite good, was very poor today.
EXTREME BODY HEAT; SHAKING ALL OVER MY BODY; CHILLS; NAUSEA; HIGH FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extreme body heat, shaking all over my body, chills, nausea, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme body heat, shaking all over my body, chills, nausea, and high fever. This report was non-serious.
Client given moderna vaccine at 1038 AM 10/4/21 at flu/covid clinic - only covid vaccine given -  at 1044 AM clients co worker informed CCHD staff that client passed out as he was noted to snore - CCHD staff noted client to be very pale, diaphoretic - client shared with CCHD staff that he was having a hard time breathing - CCHD staff nurse instructed other CCHD staff to call 911 - CCHD staff nurse got ice packs and placed in back of clients neck and on arm, staff nurse also ammonia smelling salts, cool cloth placed on clients forehead, and client provided with water and small amounts of trail mix - client verbal and answered questions  when asked, however, noted to be quiet - ambulance staff arrived and clients vitals at 76/54 left arm, O2 at 96% RA, radial pulse not palpable per EMT, however, pulse on pulse ox at 46 - ambulance took client to ED for evaluation/treatment