chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passed out; dizzy; nauseous; hit her head/huge bump on head; My left eye is half swollen shut; eyelid and under eye are black; very swollen all over head and eye; in lots of pain; breastfeeding; breastfeeding; This is a spontaneous report received from a contactable consumer (who is also the patient). This consumer reported events for mother (self) and child. This is the maternal report.   A 35-year-old female patient received the first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration in the left arm, on 06Apr2021 12:15, as single dose, for COVID-19 immunisation, at a drug store. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no prior COVID-19 and was not tested for COVID-19 post vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not received other vaccines in four weeks. On 07Apr2021 at 03:00, the patient went to the bathroom and felt fine. She sat on the toilet and all of a sudden felt dizzy and nauseous. Next thing she knew, she woke up on the floor and had a huge bump on her head near her left eye. She passed out and hit her head on the tile in the bathroom. Her left eye was half swollen shut, her eyelid and under eye were black, was very swollen all over her head and eye and was in lots of pain. She went to the emergency room around 04:30. All tests, CT scan and blood work came back normal. She was told that it was most likely caused by the vaccine. Treatment for the events included "CT scan, bloodwork, IV fluids" (as reported). She was hoping that Pfizer will pay for her ER visit since the events were vaccine reactions. She reported that she was still in lots of pain and was not taking pain meds because she was breastfeeding. The events resulted to emergency room and physician office visits. The outcome of pain was not recovered. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442302 Baby case
Pt became dramatically apneic 5 days after receiving flu vaccine. No other SX noted.
A week after the bruises appeared patient had syncope episode and a heart rate of 160s; A week after the bruises appeared patient had syncope episode and a heart rate of 160s; Patient was tested for COVID and came back positive; Patient was tested for COVID and came back positive coded as COVID-19; After patient received COVID vaccine bruises appeared all over patient's body; This is a spontaneous report from a contactable other health professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  After the patient received COVID vaccine, bruises appeared all over patient's body on an unspecified date. A week after, the bruises appeared. Patient also had syncope episode and a heart rate of 160s. Patient was tested for COVID and came back positive. A week after showing positive for COVID, patient started to show Covid symptoms. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the company assessed there was not a reasonable possibility that the reported events Syncope, Heart rate increased, Covid -19  were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On 6/20/01 pt started running fever of 102 F; called PMD and they advised to give Tylenol and watch. On 6/21/01 pt was cranky and fever was 102 F. At 1:30 PM started gasping for breath in sleep, started jerking and eyes rolled back in head. Called 911 and ambulance gave O2 and fever was 105 F. ER did blood and urine text and x-rayed chest.
Chest pain, tacycardia, body aches, skin tingling all over body, anxiety
Myalgia First side effect was left arm pain, then today myalgias especially lower back and fatigue; some relief with Tylenol Narrative:
Extreme headache, severe dizziness, chilled (unable to get warm), pain in wrist areas, respiratory (hard to deep breath)
Presented to the ED with rigors, rash vomiting, and diarrhea. He was found to be mildly hypotensive in the ED. He also had a WBC count of 20500 and a diffuse maculopapular rash. He was admitted for probable COVID vaccine allergy.
First day sore arm at injection site. Less painful than previous doses. Felt fine for 2 days with little nausea, decided to go to work overnight shift. During lunch; decreased appetite and bloating, Nausea increased to moderate and severe abdominal pain. Hot and cold sweats but no fever, multiple stools. Debated leaving work early. Managed to make it home after shift, took  Pepto Bismol and gas x and slept more than usual. Decreased appetite until Day 5 returned to work and felt okay but a little weak. Day 6 woke up in the middle of sleep and had severe abdominal pain and nausea. Tried to take Pepto Bismol and gas x with no relief. Debated going to the Emergency room. Could not go to work. Hot shower helped relieve the pain to go back to sleep. Unable to drink water due to nausea. Slept for 14 hours woke up feeling queasy, able to eat a little rice and chicken broth.
AFTER RECEIVING THE FLU MIST 30 MIN'S LATER COMPLAINED ABOUT STOMACH HURTING. BY THE TIME WE GOT HOME AT 4:00PM THAT DAY HE HAD TEMP. OF 102% AND CONTINUED THROUGH THE NIGHT CALL THE DR. NEXT DAY.  THEY DID NOT GET BACK WITH ME.  GAVE HIM TYLENOL ALT. WITH ADVIL ALL THAT WEEKEND FEVER 102-103 AND HE WAS COMPLAINING OF ACHES IN LEGS. FEVER CAME DOWN WITH MEDICATION AS SOON AS WORE OFF CAME BACK. TOOK HIM BACK TO DR. MONDAY 11/5/2012 SHE SAID IT WAS ALLERGIES.  GAVE HIM MEDS FOR ALLERGY NASONEX AND CLARITIN.  TUESDAY NO BETTER SLEEP ALL DAY AND STILL HAS FEVER GOING ON 6 DAY'S. WENT BACK TO DR. WEDNESDAY TESTED POSITIVE FOR FLU AND STREP.  TAKING TAMAFLU AND TYLENOL AND ADVIL. SEEMS TO BE DOING BETTER BUT STILL HAS FEVER IF NOT MEDICATED ON TIME BUT NOT AS HIGH. DR. SAID HE WOULD BE BETTER BY THIS MONDAY 11/12/12 AND COULD GO BACK TO SCHOOL. WE ARE SURE HOPING SO.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 24Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received other medication in 2weeks. The patient took Paxlovid for COVID 19 treatment. The treatment start date was reported as 20Jun2022 (lot number: GC0490). The patient had no known allergies.
9 AM 2/14/14 Mother called HD. Mother stated child had imm 2 day ago. Left arm now red, hot to touch and size of tennis ball. Advised to call pediatrician.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (therapy type was rHA, dose and route were unknown, lot # L029266 with expiration date 04-AUG-2017, lot # L039612 with expiration date 07-OCT-2017, lot # L037356 with expiration date 28-SEP-2017, and lot # L036853 with expiration date 24-SEP-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt became pale, diaphoretic, dizzy, nauseated, approx 5 min after injections. Resolved 10 minutes afterwards.
Patient developed blister lesions and some pustules on the left face and left arm and left breast.  On the breast she had itching and burning. All lesions resolved in 3 days except still has some small pustules on the left breast now (8/10/18).
Initial report was received from a health care professional on 30 March 2011. A 79 year-old female patient had received an Influenza vaccine and a Pneumonia "shot" (manufacturers, lot numbers, routes and sites of administration not reported) on 24 March 2011 and an unspecified amount of time later, was reported to have "gone downhill" and to have a blood pressure that was "out of control". The patient had been transferred from another hospital to the reporter's hospital. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 28-JAN-2019, the patient was vaccinated with VARIVAX (frequency, dosage, strength were not reported) for prophylaxis with the respective sterile diluent. Call was due to a data logger Temperature/time (47 Fahrenheit to 77 Fahrenheit ) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On an unknown date, the nurse stated patients received unspecified doses of VARIVAX that were improperly stored (product storage error).
Received MMR vaccine 6/18/2004. Symptoms began 6/27/04 with cough, fever, coryza, malaise and rash. (Father said child has a little cough/fever 6/23 + 6/24 then subsided)
Patient was new refugee here for physical/immunization.  After seeing doctor, patient had labs drawn/immunizations.  Patient showed signs of anxiety because she said she never had shot before.  Patient was taken into lobby and about 15 minutes she c/o nausea.  I was putting her into room to sit and she passed out on floor before breaking arm.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe pain at top of stomach, back and lungs with difficulty breathing, inflammation.  Severe vomiting for 2 days, headaches, chills, fever, sweats, clamminess.   Headache and fever continue Sunday (today) 3 days after  1st shot.
pt recv vax & 1mo p/vax pt tested negative on a VZV screen, but tested positive w/the ACIF test w/a result of 1:4;
Patient called over 72 hours after getting vaccination stating 2 small dots, redness, swelling, and itching on the front part of the arm in which she received the shot. Was able to clarify was not where the shot was given but on the same arm, closer to her body on the front part of the arm.  Patient insisted I report the reaction to the VAERS reporting system despite my asking if it could possible be a bug bite. Patient refused to believe symptoms could be caused by anything other than the vaccine. Recommended oral Benadryl to the patient at a dose of 25mg every 4-6 hours and to let her doctor know/ go to closest Emergency Room if develops trouble breathing or if symptoms don't subside with treatment of Benadryl.
n/v, fever, sore throat, chest & nasal congestion, fatigue, arm of inj extremely painful;
This case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (Shingrix vaccine was administered over 2 years ago.). On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced unexpected therapeutic effect and fever blister. On an unknown date, the outcome of the unexpected therapeutic effect and fever blister were unknown. It was unknown if the reporter considered the unexpected therapeutic effect and fever blister to be related to Shingrix. Additional details were reported as follows: The patient had suffered with fever blisters through his/her entire life. The patient reported that he/she had administered with dose of Shingrix over 2 years ago and experienced a positive side effect of reduction in fever blisters. Age at vaccination were not reported. Consent to follow up was requested.
Severe flue like symptoms. My arm was killing me for 1 week. I had a horrible headache for 5 days. My body ached for 3 days. I couldn't get out of bed for 2 days. It was worse than COVID.
Pfizer COVID-19 Bivalent Booster 12+ dose given to child under 12. Child experienced headache and fatigue 36-48 hours after vaccination.
Coughing for 16 days no coughing at night but would cough non uncontrollably all day till exhaustion falling asleep at night. No medication relieved cough at all. Breathing treatments no effective. After 4 MD visits went to naturalist was given essential oils that stopped cough within the hour.
pt recvd vax & 24 hrs p/2nd dose exp hives, which were treated w/DPH tablets & resolved;
Vomiting. A mother reported that her child received Prevnar and PPD on 3/8/01. That same day she developed vomiting and did not want to eat or drink anything. On 3/9/01 the vomiting resolved but the child developed a runny nose.
A serious spontaneous report of paralysis on the right side of his face was received from the mother of the patient concerning a 13 year-old male subsequent to FLUMIST.  Medical history included allergies and concomitant medication included fluticasone propionate.  The patient received a dose of FLUMIST on 13-Oct-2008.  A total of one dose was received before onset of the event which occurred eight days later.  The child's mother called to report her son on 21-Oct-2008 complained of paralysis on the right side of her face.  The child stated that, "my right eye will not shut right" and "my smile does not work."  He was taken to an urgent care clinic on 22-Oct-2008 where blood work was drawn but no diagnosis was given.  On 24-Oct-2008 the child was seen by his primary physician who tested for Lyme's disease and was negative.  The child was seen by a Neurologist, exam was negative except for an initial tongue extension test that initially showed deviation to the left but a re-test showed straight extension.  The mother stated that there were no plans for future diagnostic imaging.  Per the mother the child continues to exhibit symptoms no improvement or worsening of condition was noted.  The mother stated that the Neurologist believes the child's symptoms may be attributed to either a virus or FLUMIST.
Pt presented to the ED on 8/31 w/complaints of weakness, cough and fever. She was found to be positive for COVID and had a temp to 103. A CXR showed bilateral infiltrates and she was admitted overnight with discharge on 9/1/21 Sepsis Tmax 103.1, HR 120, WBC 12.19 In setting of pneumonia, suspect viral etiology with COVID Check lactate Check antigens, cultures, procalcitonin Resolved   Covid-19 Pneumonia COPD with acute exacerbation Date of onset of symptoms: 8/28/21 Symptoms present on admission: Cough, fever, fatigue, headache Date of covid positive test: 8/31/21 Vaccination status: vaccinated Imaging: CXR with bilateral diffuse infiltrates Oxygen requirements on admission: room air Current oxygen requirements: room air Medical therapy: no COVID-specific therapy indicated Continue Azithromycin, and Prednisone for AECOPD component
A consumer report has been received. The report concerns a 2 year old, female consumer, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 03-NOV-2014.  The patient experienced fever, chills and restlessness which started on 03-NOV-2014.  FLUMIST Quadrivalent was discontinued on 03-NOV-2014. The outcome of the event fever, chills and restlessness is unknown. The report was considered to be non-serious.
I had a lot of pain everywhere after the 2nd dose on 4/6-7/21. On 4/7/21 I had blurred vision most of the day.  I had pain in my eyes on 4/8/21. On 4/12 at 12-5PM my body felt hot, but my temp kept showing 98.6; at night since 4/12 I've had chest congestion & coughing. On 4/19 during the day my body felt hot & didn't feel like myself.
Around 1:00 pm felt nauseous went away. 8:30 pm soreness in arm nausea around food. 9-10 pm chills, fever, muscle aches. 2:30-4:45 am on 3/26/2021 headache, chills, muscle aches. 5:15-6:00 am headache
This spontaneous report as received from a medical assistant and refers to a 75-year-old female patient with no medical history, concomitant medications, drug reactions nor allergies. On 13-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection, lot # N019983 with expiration date on 03-MAR-2019 (dose and route of administration were not reported). On 14-NOV-2017, the patient presented at the physician's office complaining of swollen, tender and sore arm. The patient also could not lift her arm at all. The physician recommended to treat the events with BENADRYL and ice as needed. The patient did not recover from the events at the time of the report. The relatedness between the events and PNEUMOVAX23 was not reported. The reporter considered the inability to lift the arm to be a significant disability/incapacity, as the patient had been written of the work for the week due to that event.
Swollen lymph node under right arm, injection site red, warm, raised and hard. very painful at site.
No additional AE reported; temp excursion 47.9 degrees; This spontaneous report was received from a certified medical assistant and refers to a 2-month-old female. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported.  On 19-DEC-2022, the patient was vaccinated with the first doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly in the left tight (dose was not provided) and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally (dose was not provided); both for prophylaxis. On 01-DEC-2022, the vaccines underwent a temperature excursion of 47.9 Celsius degrees for 47 minutes (Product storage error). Data logger was involved. The medication error occurred at storage in practice. No additional adverse event (AE) reported.
Starting at 1pm, I could not speak, what did come out of my mouth was gibberish.  I could move my arms, legs, and had a good hand grasps. Walked to the kitchen and sat in a chair.  My husband drove me to the ER (about 30 min away).  CAT scan of head was normal.  EKG was normal. Speech was starting to come back by 2pm. I could answer questions in 1 or 2 words. I had a virtual consult with a stroke dr, he did not think it was a stroke. By 3pm my symptoms were resolved. Was in the hospital overnight.
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/16/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21
death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for amyotrophic lateral sclerosis, AF, HTN. No notation regarding death, or cause of death. Patient deceased 4.16.21
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 28-FEB-2018, the patient received a properly stored but expired dose of Oka/Merck VARIVAX, subcutaneously for prophylaxis, lot # M009766 and expiration date on 23-FEB-2018 (dose and anatomical location were not reported). No adverse effects were reported for the patient.
Information has been received from a physician concerning a 2 month old patient who was vaccinated with a first PO dose of Rotateq. Subsequently the patient experienced explosive diarrhea which lasted 3-4 days. The series of doses was discontinued. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
One day later, patient had an absence seizure. Four days later, full body rash starts to develop. Gets progressively worse for the next week. Seven days later the high fever starts. Stays high for a week. Very sick lethargic demonstrated, not eating. One night of hysterical jerking and screaming. One day following the administration of the vaccines, the patient appeared to have an absence seizure for a couple of minutes. Patient appeared to be awake, staring into space and was unresponsive to vocal and even physical contact - No treatment given. Four days following the administration of the vaccines, the patient developed red spots over the back and torso. The patient developed a high fever two days after the rash began and was sick for the next 10 days, getting progressively worse for the first seven, before slowly recovering. The patient developed a measles like rash over the entire body, increasing spots each day, progressing to the face and down to the hands and feet. The high fever was between 103-105 degrees. The patient was lethargic, behaved unusual, she became dehydrated and experienced vomiting. Several doctors were seen during this time. The red spots took a couple of months to totally disappear. At bath time, the spots would reappear as faint marks. The patient has developed reddish spider veins on her upper back and facial cheeks where measles marks had been located. One night during this period of acute illness, the patient was acting hysterical. She would try to fall asleep for about 3 minutes and then suddenly jerk and start screaming. She continued this pattern for hours, finally coming to rest about 4:00 am. We made an urgent call to the doctor this night, but did not go to the hospital.
high pitched cry X 6hrs, stiffened extremities, Temp to 102 T., Site of injection swollen