chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient presenting to hospital OB department received Moderna doses on 1/20/21 and 2/18/21.  She received them from health department at a clinic.  She self-quarantined from 3/15 to 3/31 due to approaching her delivery date.  She was in contact with 2 friends on 3/10 which both tested positive on the 22nd and 26th respectively.   She presented to OB initially on 4/1 for labor & delivery.  She was found to be COVID positive at this time after being COVID tested - she had no prior symptons of COVID.   She had to have an unscheduled c-section after 24 hours in labor.  While laboring she did go into a critical blood pressure range.  She was treated appropriately with medication.  Patient did well postpartum and postop.  Lungs were clear and patient afebrile.  Patient discharged 4/4.    Patient returned to hospital on 4/6 for elevated blood pressure (was advised on previous discharge to monitor blood pressures at home and to report if elevated).  Her inpatient stay involved being treated for elevated blood pressure with magnesium sulfate, nifedipine, and labetalol.  She had swelling in lower extremities and has had a Doppler study which showed no DVT.  She was on a blood thinner enoxaparin though because of postop status and also COVID.  She went home on 4/10 advised to follow up with provider if any more issues were to arise.  She went home on enoxaparin 40mg subcutaneous for 10 days, nifedipine ER 60mg daily, and labetalol 400mg three times daily.  Blood pressure elevation probably related to course of L&D case but reporting due to the fact that patient had received both doses of the COVID vaccine and had tested positive during the course of the L&D.
One week after the injection,my daughter broke out with big hives,rash and itching. She was put on predizone.That did not sseem to help very much. It is a little over a month and she is better but still breaks out with red bumps and  hives.
16-year-old received both doses of vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received both doses of vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received both doses of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received both doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Low grade temp. Diffuse muscle aches, swelling, headache, nausea, anxiety, elevated BP, bruise at injection site.
Lower part of arm was injected; my arm was sore about 12 hours after the vaccine. On Thursday, the 21st, I thought I was coming down with UTI with blood in my urine, and frequent urinating .  I scheduled an appt for the 25th - but they wouldn't see me because I had COVID symptoms. Saturday, 23rd - started feeling unwell; next day, I felt like I got hit by a bus - achy, fever, cough out of nowhere - like a pneumonia cough and then my watch kept giving me alarms of my heart rate was too low. My oxygen was from 70-80 for about a week. I had an inhaler - and I used that. I used BOOST oxygen - and that helped my pulse oxygen level go up. My doctor, on Tuesday, the 2nd,  (a virtual appt) put me on a couple of different antibiotics - for atypical pneumonia for one of them for COVID - Doxycycline; Decadron; and the other one was for Macrobid; Diflucan for UTI for two or three weeks I was recovering. I was sick for about four days more than my official isolation period - so off work for about 2 1/2 weeks.  I went back to work on the 10th. Still to this day - I get a low heart rate alert. I delayed the second vaccine.  Had the second vaccine on March 16, at 03:00PM.
This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in an adult male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included dialysis.  The subject had no allergies.  Concurrent medications included Multiple unspecified medications.  On 12 February 2007 the subject received the 1st dose of Engerix B (40 mcg, unknown).  Two days after vaccination with Engerix B, blood work was completed.  On 15 February 2007, 3 days after vaccination with Engerix B, the subject was found to be hepatitis b surface antigen positive.  Previously, the subject was hepatitis b surface antigen negative.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was probably related to vaccination with Engerix B.
Chills - sporadic for 36 hours; spiking mild temperature sporadically for 36 hours (99.7); aches in muscles and joints for 60 hours; fatigue      for 60 hours; loss of appetite - still ongoing; headache - still ongoing; tenderness  and swelling of injection site still ongoing; soreness and tenderness of lymph nodes in left underarm developed approx. 48 hours after injection and is ongoing (36 hours)
Had flu shot and had metallic taste in mouth. Then started feeling dizzy and had shortness of breath. Pharmacist said she might need to go to ER. Case worker took her home she had some diarrhea and skin began to itch. Fiance came home took her to ER. Gave BENADRYL and sent home with BENADRYL p.o. No further problems.
Few hours after Adacel and flu shot -> severe myalgia, increased gas, diarrhea, decreased appetite dizziness, fever (100-101 degrees) -> Tylenol, Gas X, pepcid
Clients mother noted headache that occurred 2 hours after immunization that progressed to vomiting the day after. Recommended client seek medical care.
Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 65-year-old male elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     MEDICAL HISTORY (Patient): Medical history and concomitant medication were not reported.    On 19-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the elderly was diagnosed with COVID-19 (Tested positive for Covid). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, COVID-19 (Tested positive for Covid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On Unknown day in Feb,2021 patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 Vaccine) No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional information received On 01-Jul-2021: Follow up
After shot sore arm, dry mouth, fatigue, muscle pain 10 days later large red rash near injection site.
Dizziness; lump in throat; Leg cramps; This is a spontaneous report from a non-contactable physician. A 29-year-old non-pregnant female patient received BNT162B2 (Pfizer BioNTech, Batch/Lot Number: EL3248, Expiry: Unknown) dose 2 via intramuscular route of administration, administered in Arm Left on 11Jan2021 at 12:30 as SINGLE DOSE for covid-19 immunization. Medical history included gastroesophageal reflux disease and rhinitis allergic. The patient's concomitant medications were not reported. On 14Jan2021 02:30, the patient experienced dizziness, lump in throat and leg cramps. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Feb2021 covid test type post vaccination. Nasal Swab covid test name post vaccination PCR. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, lymph node selling Narrative:
pt came to office on 17JUL97 mom pointed out an indentation on the pt rt buttock asking if it is d/t DTAP on 4MAY97;mom was asked if p/vax any redness or swelling said no but indentation from shot;
Began feeling ill a few hours after receiving vaccine. Rash appeared the day after receiving the vaccine. Rash started on arms and covered entire body within a few hours. Took Benadryl and went to bed. Rash was gone the next day.
redness; slight rash; This case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included grover's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema and rash. The patient was treated with topical steroid nos (Steroid Ointment Nos). On an unknown date, the outcome of the erythema and rash were recovered/resolved.   It was unknown if the reporter considered the erythema and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingrix 3 months ago and had redness and slight rash which appeared a month ago and cleared up. The patient used steroid topical ointment.
First had a small cold sore pop up inside my mouth around 6 PM, which I didn't worry much about because I know that cold sores, shingles, and chicken pox are all in the same Herpes family, I figured the vaccine probably triggered a reaction and my immune system was needed to kick in. The cold sore went down quickly, around 8 PM, but then I started with a low fever, shivers, body aches started around 8:00 PM on 12/07/2021. The body aches and shivers continued till about 10 AM on 12/08/2021 when my fever broke. I felt okay for a couple of hours, then by 4 PM, I had some body aches and shivers again, not as bad as the night before, so I took Tylenol and went back to bed. I took Tylenol about every 6 hours when the shivers and body aches started; I did not supplement with an Ibuprofen or other NSAID as I am trying to stay off anything blood-thinner related for a. biopsy procedure I have coming up next week. I slept till 10:00 AM on 12/09/2021, and finally feel back to normal. Body aches, shivers, and fever seem to be done, but this 2nd dose of Shingrix really "kicked me in the teeth" (metaphorically).  I am hoping I am done with the side effects.
DEEP VEIN THROMBOSIS (DVT); This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto thyroid, alcohol user (twice a week), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no drug abuse or illicit drug usage. The patient was on birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 11-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 39 years old. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate for birth control, and levothyroxine sodium (Synthroid 125 mcg once daily) for hashimoto thyroid.  On 24-DEC-2022, the patient, got out of the car and her right leg hurted. From then pain continued until last Thursday (05-JAN-2023), so she went to primary care doctor. The doctor ordered a doppler venous ultrasound and DVT (deep vein thrombosis) was confirmed on Thursday (05-JAN-2023) night. On Friday, 06-JAN-2023, the patient started Xarelto starter pack twice daily (15 and 20 mg). No more tests were done besides the doppler. The patient had no other side effects from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis (DVT) was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230119687.; Sender's Comments: V0: 20230119179- deep vein thrombosis (DVT). The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Patient was sitting in chair after vaccine, awaiting his 15 minute assessment period. Patient's head fell back in chair and patient had syncopal episode x 10 seconds. Patient assessed by EMS crew on site, VSS, patient AMA.
Swollen red spot 1 inch from vaccination site; Swollen red spot size of 50 cent piece; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical history reported.  Concomitant products included INSULIN for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece). At the time of the report, VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Heart rate: increased (High) Increased. On an unknown date, Blood glucose: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. Concomitant medications reported were Insulin, medication for blood pressure, eye drops for glaucoma, medication for diabetes.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Slight Fever to 100.6, Confusion similar to delirium--pt talked non-stop for several hours; he kept repeating things and said things that didn't make sense.  He also made up songs and would sing out and laugh.  He was unable to sleep during this time and would go back and forth from talking as above to whining about his legs.  He didn't want to walk or move his legs due to pain.  I gave him acetaminophen, and his fever eventually lowered slightly.  The symptoms of delirium lasted approximately 4 hours but lessened with each hour.  At the end of that time, he finally fell asleep for 2 hours.  He awakened and had more normal behavior.  However, he still had slight fever throughout the day and had difficulty walking.
Fell; Blurred vision; Very weak; Passed out; A lot of pain; Chills; A spontaneous report  was received from a 66-year- old female patient who experienced a lot of pain, chills, fell, blurred vision, very weak and passed out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 08 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced pain at injection site, chills.   On 09 Feb 2021, the patient fell, had blurred vision, very weak and passed out. She spoke to her doctor who recommended rest.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event passed out was resolved; outcome of the events, pain at injection site, chills, fell, blurred vision, and very weak, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L004745, expiry date 28-APR-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of VAQTA underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US015521, is an initial spontaneous report from a nurse received on 30 Jul 2014 and with a follow up information received from a nurse on 05 Sep 2014. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. On 29 Jul 2014, she was administered only Men CYW-135 liquid component of MENVEO (batch number: X13058) without being reconstituted with Men A (see case: PHEH2014US015362). She was administered Men A powder component of MENVEO (batch number: M13058) reconstituted with sterile water instead of Men-CYW-135, intramuscularly in the left deltoid on 30 Jul 2014 at 10:30.  No adverse reaction was reported following this administration error (wrong solution used in drug reconstitution).
Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms particularly reduced with ibuprofen 600 mg
A seven-year-old girl came to the pharmacy with her mother and grandmother to get a flu shot (only the girl and mother were getting vaccinated).  The mother filled out our consent form, medical record was checked and the girl had received Fluzone Quad in the past.  They were rung up at the register for the vaccines and the VIS form was provided to them.  As per the consent form there had been no record of adverse reactions to vaccines in the past.  The mother did not have concerns regarding the vaccine and just asked how long it would take to kick in and start working.    Fluzone quad preservative free 0.5mL was given in the left thigh due to her age and thin arms, this vaccine is FDA approved ages 6 months and up at this dose.  She was sitting in her mother?s lap at the time she was given the vaccine.  She was very worked up/screaming/crying about having to get a vaccine, for which the mother was apologetic about.  After the vaccine was given the girl calmed down, she started eating starburst candy, and appeared to be doing well.  The mother was then given her vaccine.  Once that was completed I asked the girl how her leg felt and she stated ?it hurt? which was expected after giving the vaccine.  They got ready to leave the pharmacy.  As they started walking the girl passed out, eye?s were in the back of her head, and she had some tonic-clonic-like symptoms.  This was about 3-5 minutes after her vaccine had been administered.  As this was happening I had one of my technicians call 911 to get EMS.  The girl?s tonic-clonic symptoms lasted less than 10 second and she started to wake up.  She had been standing next to a wall at the time she collapsed, so it is possible that she hit her head on the wall or on the floor.  The mother was able to grab ahold of her to lessen the fall.  When she was awake she remained on the floor and was not moved until EMS had arrived.  While waiting for EMS she was asked questions such as where she was and who she was with.  Her face was very pale.   Mother asked why this might have happened, I stated that it could have been due to the fact that she was very worked up at the time the vaccine was given as that can cause someone to pass out.  Mother stated this had never happened before. EMS arrived, took vital signs which they said were normal.  They recommended that she was taken to the hospital due to seizure-like activity.  They were given the option by EMS to go in an ambulance or through their own transportation means.  I do not know which option they chose. EMS did not have any further questions from me, however they did take my name for the report.  A VAERS report was completed for this incident.
Pt was given vax @ 10AM & @ 2PM had temp of 104; Pt was taken to ER & given meds that brought temp down; Pt was found to have an ear infection @ the time;
Pt c/o onset of itching, warmth, and tingling with lower lip swelling at 11:10 AM.  Pt given Benadryl 50mg cap PO and Prednisone 20mg tab PO at 11:15 per direction of Medical Director.  VS-84-20  138/78 SPO2 96% on RA at 11:12. Symptoms did not progress after medication administration and pt/staff left the facility to go home at 12pm.  She was advised to f/u with PCP.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient with unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  In 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, route, lot # and expiration date were not reported).        On an unknown date, the patient experienced shingles and was hospitalized. As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, plaintiff has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).Additional information has been requested.
Pt first developed a fever of 102 on Sat 9/18 and treated with Tylenol. On Sun 9/19, she had a nose bleed, treated with compression until symptoms resolved. On Mon 9/20 pt had itching that progressed to hives on Tues 9/21 and a very "cold feeling to the touch". This was not treated to the best of my knowledge other than the initial Tylenol. Pt called me on Wed 9/22 to report this but did say she was beginning to feel better.  I followed up with pt today, 9/24 and pt claims that all symptoms have resolved
pt had elevated temp of 104.5 w/high pitch cry; pt had sz around 630-7PM; mom unsure how long lasted; pt had high pitched cry over 4 hrs;