chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a consumer on 20 Jun 2012. A 75-year-old female patient, whose medical history like several allergies but did not list and concomitant medications was not reported, received ADACEL vaccine (lot number: unknown, route and site of administration was not reported) on 15 Feb 2012. The patient had experienced flare up of eczema on 5 weeks after vaccination. Outcome of the event were not recovered. List of documents held by sender: none. Follow-up information received on 29 August 2012: The patient received ADACEL vaccine on the right arm (deltoid region) with lot number reported as U4308BA. The patient had multiple medical issues (not specified) lifelong or for many years.
Unbearably metallic taste in the mouth interfering with taste/smell for ~1 week; better by day 8 but still not completely gone.
traditional fatigue; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (traditional fatigue) and MYALGIA (muscle soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     Patient other concurrent condition included Age related eye disease, No change in status reported. Patient has never been diagnosed or tested positive for COVID-19. Other vaccines given within one month or prior to Moderna COVID-19 vaccine was reported as unknown.  Concurrent medical conditions included Osteoarthritis (Started 10 to 12 years ago or longer. condition worsening), Coronary artery disease (No change in status reported .), Depression (No change in status reported .) and Immunosuppression NOS (Immunologically suppressed, No change in status reported .). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), DULOXETINE HYDROCHLORIDE (CYMBALTA), VITAMIN D NOS and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jan-2021, the patient experienced FATIGUE (traditional fatigue) and MYALGIA (muscle soreness). At the time of the report, FATIGUE (traditional fatigue) and MYALGIA (muscle soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant medications included Areds eye vatamins, Two fish oils, Vitamin B and folic acid. No treatment medication information provided.   This case was linked to MOD-2022-560464, MOD-2022-560462, MOD-2022-560457 (Patient Link).
Routine blood work done at primary care office (physical) 11/17/22 Liver function test bad - repeated - 12/19/22 - normal I had flank pain after vaccines. took a couple of weeks to resolve. I went to Dr. office for routine blood work R/T taking Atorvastatin. all my liver enzymes were elevated - but this result has since been removed from my potal. 12/19/22 - my portal says stable labs 3/9/23 - repeat normal labs (increase .39 improved ALT) May have been an error in labs. I don't know.  FYI - I tried to do this on line but halfway I got timed out and it wanted me to start over - too much for us seniors.
ELEVATED LIVER ENZYMES; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and non smoker, and other pre-existing medical conditions included the patient had no history of any drug abuse or illicit drug use and no pre-existing conditions.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced elevated liver enzymes. Laboratory data included: Hepatic enzyme (NR: not provided) Elevated liver enzymes. The action taken with covid-19 vaccine  was not applicable. The outcome of elevated liver enzymes was not reported. This report was non-serious.
Used sterile diluent instead of diluent that was included with vaccine.  No adverse reaction reported.
Patient became diaphoretic, pale, hypotensive, BP dropped to 86/ 43, HR: 41 SaO2: 98%. patient was placed in a Trendelenburg position, O2 via nasal canal at 2 liters per min. administered IV line with normal salin given. BP recovered ( 137/94) he was transferred to ED in stable condition
Information has been received from a pharmacist concerning a male "over 60" year old who on an unspecified date was vaccinated SQ with a 0.65mL dose of ZOSTAVAX (Merck) (lot number not provided). The pharmacist reported that the patient developed chickenpox after receiving the vaccine. The reporter described it as "head to toe breakthrough varicella". The pharmacist said that this adverse event had already been reported. It was not specified if the patient sought medical attention. Additional information is not expected.
Information has been received from a physician concerning an approximately 5 year old female who was vaccinated with a dose a VARIVAX (Oka/Merck). The physician reported that the patient experienced an unknown type of injection site reaction. The patient was treated with antibiotic. At the time of the report the patient was assumed to be recovered because she had not been in contact with the office since. Additional information has been requested.
On 1/17/21 at approximately 8:00 p.m., Patient noticed her lymph nodes were swollen on the left side and she was unable to move her neck.  She was better by 1/24/21
Loss of use of left arm. Slow speech.  Loss of balance. Confused spatial awareness. Rash. Headache. Falling. Lethargic.  Loss of appetite.  Not drinking.
Raised half dollar sized area, red in center on 5-19-10 @ 10:AM. On 5-20-10 @ 6:30AM noticed seizure had enlarged to 4.5" x 3.5" of redness with blisters in center measuring 1"x 1".
A 40 y/o female patient presents with diaphoresis and dizziness immediately after being immunized with the Pfizer Covid Vaccine (Booster Dose).   The patient was taken to the paramedic area and vital signs were taken. The pressure was slightly elevated 130/100, which is normal in a hypertensive patient which had not taken her medication, Labetalol. Other than that, the patient was slightly tachycardic. She refers similar episodes with other stressors, such as other types of vaccination, although she did not give specific examples. She was discharged with stable vital signs and referred to feeling better.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unspecified dates during the past three months in 2016 the patients were vaccinated with improperly stored VARIVAX (lot #, expiration date, dose, frequency and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tested positive for Covid; Tested positive for Covid; mild Cold symptoms; Loss of taste/smell; Loss of taste/smell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient was 60 something, and it was unknown weather she received booster dose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "mild Cold symptoms"; ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "unknown" and all described as "Loss of taste/smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028605 same drug/event, different patient
36 hrs after ROTARIX pt with uncontrollable vomiting and viral septic shock; required oxygen briefly and aggressive fluid resuscitation. Pt had septic work up and only positive finding was stool enteric swab for Rotavirus. Diarrhea followed the vomiting and shock-like episode.
Body ache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) and PYREXIA (Low grade fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Oxygen therapy since an unknown date. Concurrent medical conditions included Diabetes and COVID-19.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body ache) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN (Body ache) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to car, migraine aura started. I rarely get migraines. Got worse and worse as I drove home, could barely see. Severe headache followed.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient comes in complaining of bruising at injection site following moderna bivalent vaccine. Previously he had gotten pfizer doses for primary series. Bruising about 3 inch diameter. No improvement since day of vaccine. Not painful. Patient is not on blood thinners that he is aware of. Patient states site is not warm to touch and not particularly tender. Refered patient to PCP for followup.
Looks like a 5 cm area of inflammation to arm at injection site. Mother gave Loratadine antihistamine and cold compress. As of today's date redness and swelling have gone.
On 6/15/00, the baby woke up screaming and cried all day, had a fever of 101, had seizure at 5:00 PM, was taken to ER and admitted. On 6/29/00, the pt has recovered.
Administered HEP A into R deltoid.  Then administered GARDASIL into R deltoid.  10-15 seconds later, patient lost consciousness + fell backwards from sitting position onto exam table.  About 5 seconds later, pt began to have myoclonus movements on extremities, lasting < 7 seconds.
Severe Headache and disorientation.  It is periodic.  Events last about three days then reoccur five days later lasting two to three days.  This cycle persists to the present.
She has already had covid 19, Both have had the first covid vaccine; She has already had covid 19, Both have had the first covid vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose bnt162b2 (Pfizer Covid 19 Vaccine, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as first dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was asking if she needs to get the second dose of the covid vaccine if she has already had covid 19 in the past. Patient had covid-19 and patient had the first covid vaccine on an unspecified date. Patient concerned about side effects. The patient underwent lab tests and procedures which included covid-19: positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I was given Moderna vaccine first dose in right arm. Sat down in observing area, within a few minutes I had a weird feeling, felt queezy. As soon as I felt queezy I passed out. I woke up they said within about 30 seconds and had full body sweats. Stomach ache, dizzy and head was tingly like I would pass out again. My calfs hurt like they had previously had muscle cramps. I went to ER, blood and urine tests were fine, heart and blood pressure was fine. Dr said he did not believe it was an allergic reaction, and that it was a stress response. I am not sure if it is because I had COVID in December.
10 min post injection redness noted to injections site,  light headed /dizziness, weakness, strange taste in mouth, throat felt "funny" , felt like fainting.  Employee given 50mg of benadryl & 40mg  Pepcid and taken to ER.  Observation in ER for 3 hours after given steriods.  Went home at 8 pm and went to bed.  Woke up with warm rash on face, swollen ankles, and fatigue.  Followed up at Urgent Care as directed.
About 9 days after receiving the 1st shot  on 1/15/21  a rash appeared on my chest area. Raised bumps and non spreading. I have now received my second dose on 2/11/21 .Had reactions that occurred the next day of chills, muscle and body aches, slept for 14 hours, totally fatigued, headache on day 4 ran a fever and then symptoms decreased. except for the rash that has never went away.
CHEST PAIN; DIFFICULTY BREATHING; FELT BAD IN BODY; DIZZINESS; WEAKNESS; STRANGE HEADACHE; This spontaneous report received from a patient concerned an adult of unspecified 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 was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced chest pain. On 12-MAY-2021, the subject experienced difficulty breathing. On 12-MAY-2021, the subject experienced felt bad in body. On 12-MAY-2021, the subject experienced dizziness. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021, the subject experienced strange headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange headache, chest pain, difficulty breathing, dizziness, weakness, and felt bad in body. This report was non-serious.; Sender's Comments: V0;Medical assessment comment not required as per standard operating procedures, as case was assessed as non-serious.
This is a spontaneous report obtained from a contactable nurse through a sales representative. This nurse reported about two different children. This is the first of two reports. A child of an unspecified age, ethnicity and gender received, on an unspecified dater, TRUMENBA at single dose, via an unspecified route of administration, in upper leg. Relevant medical history and concomitant medications were unknown. ON an unspecified date, the patient experienced extreme pain and was unable to stand because of the pain. Clinical outcome of the events was unknown at the time of this report.
Pt tested positive for COVID RT-PCR on 3/8/2021 on admission to Medical Center, confirming that he has an active COVID infection. No clear current symptoms attributed to COVID.
22 hours after after I experienced chills and nausea  60 hours after I experienced a large rash on left arm below injection site
After booster shot (2 days later) it induced a menstrual cycle outside of my schedule (I'm on birth control) with severe cramping for one week which subsided. Menstrual cycle has lasted 14 days and has not stopped.
At 7 years of age, I fell off my bike, fractured my skull and ruptured my right eardrum.  From that time forward I have had Tinnitis.  At the age of 26 I experienced my first bouts of vertigo and, after extensive testing by my doctor, was diagnosed as having Menieres' Disease.  It has 3 symptons:  tinnitis, a documented hearing loss (there was an intensity of pitch and range of sound I cannot hear in my left ear) and bouts of vertigo.   Some weeks after receiving the shot, I noticed that my tinnitis got much louder, and I was experiencing difficulty with hearing in my left ear.  It had been 7 years since my last hearing test, so I set up an appoint with my ENT.   I thought perhaps this was just aging affecting my hearing.  Based on what I have read, I question whether it might have something to do with the Covid vaccination.     She conducted a regular hearing test, and then another that measures the health of the nerve that goes from the ear to the brain.  She found that the hearing loss was worse than previously measured and that the nerve was fine.  She prescribed a regimen of 4 Lipoflavinoids/day and to use a tinnitis app to see if we could train my brain not to pay attention to the tinnitis.   I used this therapy over a period of 3+ months.  Unfortunately the 4 Lipoflavinoids/day began to cause hot flashes, so they were cut back to 2/day.  I used headphones for the tinnitis app and found that I needed earphones or earbuds in both ears or else the tinnitis in the other ear was exceptionally loud.   Last week I visited her again.   Per office examination without additional testing, there has been no change.  She suggested that I also use a sleep sound machine, which I am now using.
Pt stated on 1/28/03 she developed coldness in left leg after vaccination on 12/17/02.
Patient received vaccine on 3/10/22. Patient presented to ER via EMS in full cardio-pulmonary failure with ACLS/CPR initiated at home (3/13/22) Pt expired 3/14/22. Unclear if they were related, advised by Health System's Infection prevention to submit VAERS, so marked "unknown" for item #21
Patient got her vaccination on Monday morning, called on Wednesday 03/17 around 12:20 and reported that she saw Blood in Urine started wedneday, Has fever after vaccination and red spot at injection site.
have shingles now/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had the vaccination a year before the date of reporting and had shingles. The patient commented that the vaccine did not prevent the patient from getting shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: W026137, which was determined to be valid, with an expiration date on 05-FEB-2024) (strength, dose, scheme, route of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported.   No additional adverse event was provided.  This case is one of several reports from the same reporter.
Pt with hx of seizure disorder (last seizure last year) seen in ER on 5/25/13 after unwitnessed ? of seizures. Mom heard him fall went in to room on ground with altered mental status EMS brought to ER had missed several days of KEPPRA. Dischg home after observation. Had rec'd 4 yo immuns on 5/24.
This spontaneous report as received from a non health care professional (office manager) refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II recombinant human albumin (rHA) or human serum albumin (HSA) (Strength, dose, frequency, route, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute M-M-R II injection, which was stored properly. On an unknown date, the patient experienced swelling of the upper arm. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 9 hours; 32 to 35 Fahrenheit degree (F) for 168 hours and 31 or colder (30) Fahrenheit degree (F) for 96 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no product quality complaint involved. The outcome of the event of swelling of the upper arm was unknown. The causality assessment was not provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002329: US-009507513-1708USA002330:
Second dose given too early in error. 1st dose 3/17/21 2nd dose 3/25/21 Patient developed shortness of breath, vomiting and pain in his head.
The client was previously vaccinated with Janessen vaccine on 05/19/2021. This was discovered after the first dose of Pfizer vaccine was administred.  No adverse reaction noted.
This spontaneous prospective pregnancy report has been received from a nurse referring to a female patient of unknown age. No information about pertinent medical history and drug reaction was reported. On an unknown date in April 2015 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, strength, route, lot# and expiration were not reported). No concomitant medication was reported. The patient visited an unspecified physician's office on 18-MAY-2015 and it was determined that the patient was pregnant. It was unknown when the patient became pregnant. No adverse effects were reported. There was no treatment given to the patient. The pregnancy outcome was pending. Additional information has been requested.
When the vaccine was administered my ring finger and middle finger went numb. Within an hour I started exp blurred vision and pounding headache. I drove home from work don't remember driving sleepy until my wife woke me up. I contacted my family physician was informed normal reaction. That Saturday exp projectile vomiting, uncontrolled shakes both arms. Later that day on Saturday we did a virtual call told as long as I wasn't exp stroke symptoms (sagging in my face, shortness of breath) it would pass 24-36 hrs. On Sunday when I work my blood sugar was about 280 feel little better was mobile. I could only go for about 20 mins at a time. I was able to work only 4 hours on November 8, 2021 and November 9, 2021. I have never felt this bad all of my joints, knees, hips extremely bad and severe fatigue.
SHAKING, REALLY COLD FOR TWO DAYS STRAIGHT, MUSCLE SORENESS