chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 36 year old patient. Received her first dose Pfizer (LOT#: EW0187 Exp: 8/2021) at 0922 on 6/06/21. At approximately 1035 patient came back to facility with a complaint of stomach pain. Patient was walked in by Lead RN and Co-lead RN. Patient stated she started to feel dizzy after being vaccinated. Patient stated that she didnt feel it was worth notifying EMT when she was in observation. Patient left vaccination site after completing her 15 minutes of observation. Patient waited at home for an hour after noticing she was feeling warmer and returned to facility for an assessment. Patient denies signs and symptoms of hives, rash, swelling, discoloration, or anaphylaxis. Patient denies shortness of breath. Patient stated that she only had coffee for breakfast. Patient was given a snack and water. Patient was asked to stay an extra 30 minutes for further observation. Patient agreed to stay. EMT took patient vital signs at 1040. BP:128/88, HR: 82, O2: 100%, temp: 98.6. EMT retook vital signs at 1045. BP: 128/93, HR: 82, O2: 100%. EMT retook vital signs at 1050. BP: 124/90, HR: 80 O2: 100%. EMT retook vital signs at 1102. BP: 124/90 HR: 82, O2: 100%. Patient stated that she was feeling a lot better and was no longer feeling any of her initial symptoms. Patient was advised to call 911 in case of any severe allergic reaction. Patient was encouraged to follow up with her PCP. Patient was encouraged to sign up for Vsafe. Patient refused to sign up for Vsafe. Patient refused to stay for the full 30 minutes of observation. Patient was advised to stay and told she was leaving against medical advice. Patient verbalized understanding. Patient left vaccination site at 1105 unassisted and with a steady gait.
On 5/6 patient reported she got pink/redness at injection site immediately after vaccination, but no rash or other symptoms.  About a week after the vaccine she then had redness, swilling, itchy, and hot to touch.  We referred her to her PCP and delayed dose #2.  Her PCP told us on 5/28 that she should not get dose #2 and was referred to an allergist.  It could have been an allergic reaction.   The pharmacy initiated the communication with PCP
After 24 yours, very weak, light headed, diarrhea after 36, multiple vomits after 38 hours. Still light headed.
Janssen COVID-19 Vaccine EUA Chills, shivering and body aches which started around 8:15 p.m. on 3/13. Severe headache through out the night and morning of 3/14. I then took ibuprofen and Tylenol which helped.
10PM - LOW FEVER, HEADACHE, BODY ACHES, FATIGUE, RESTLESSNESS   5/13/2021@ 5AM  SLIGHT COUGH STARTED; 10AM, SWELLING TO RIGHT EYELID.  HEADACHE,BODY ACHES,  FATIGUE, LOW GRADE TEMP;  1100- TEMP 99.2 AFTER IBUPROFEN 0900 AND GOODYS POWDER@ 1030
5 minutes after this patient had Hepatitis B vaccine administered she complained of feeling faint, tightness in throat area, pain in the neck and abdomen. BP decreased 77/50, 0.3 epinephrine administered, symptoms subsided. BP increased 110/60. The patient was monitored by staff and released at 12:30 pm with normal vital signs.
My thyroid antibody test was also elevated; This spontaneous case was reported by a consumer and describes the occurrence of ANTI-THYROID ANTIBODY POSITIVE (My thyroid antibody test was also elevated) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTI-THYROID ANTIBODY POSITIVE (My thyroid antibody test was also elevated). At the time of the report, ANTI-THYROID ANTIBODY POSITIVE (My thyroid antibody test was also elevated) outcome was unknown.            Lab data include thyroid antibodies were up, so patient had a thyroid antibody test done. TH3 was normal, but antibody tes. Thyroid antibody test was also elevated.  No concomitant medications were reported. Treatment information was not provided by the reporter.
A mother reported that her 8 year old daughter with common variable immunodeficiency received Prevnar "in the standard procedural way for a child on gamma globulins". Following immunization, her serum antibody value was measured to be lower than her pre-immunization value. She was seen by the physician who had the lab run the test again. No further information was available at the date of this report.
I was administering the vaccine and at the last moment right before the needle was about to retract the patient jerked and the needle came out of her arm. She received most of the medication. But she didn't receive the last amount right before the needle retracts.
Positive rapid test; Positive rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid (Batch/lot number: Ga5120) started on 18May2022 and stopped on 22May2022. Clinical course was reported as, Rebound congestion symptoms. Treatment received for symptoms was unknown and patient was not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
got covid; felt ill; excruciating headaches; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of COVID-19 (got covid), MALAISE (very bad and felt ill) and HEADACHE (excruciating headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and MAGNESIUM for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced COVID-19 (got covid), MALAISE (very bad and felt ill) and HEADACHE (excruciating headaches). On 04-Apr-2021, COVID-19 (got covid) and MALAISE (very bad and felt ill) had resolved. On 10-Apr-2021, HEADACHE (excruciating headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she was  given an intravenous infusion to treat Covid infection all day at a clinic on an unknown date.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration was reported as 7 May 2021.  No Concomitant medication was reported.  No treatment medications were reported.
Chicken Pox virus reactivated by Moderna shot a developed Shingles; Chicken Pox virus reactivated by Moderna shot a developed Shingles; This spontaneous case was reported by a non-health professional and describes the occurrence of HERPES ZOSTER (Chicken Pox virus reactivated by Moderna shot a developed Shingles) and VARICELLA (Chicken Pox virus reactivated by Moderna shot a developed Shingles) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Chicken Pox virus reactivated by Moderna shot a developed Shingles) and VARICELLA (Chicken Pox virus reactivated by Moderna shot a developed Shingles). At the time of the report, HERPES ZOSTER (Chicken Pox virus reactivated by Moderna shot a developed Shingles) and VARICELLA (Chicken Pox virus reactivated by Moderna shot a developed Shingles) outcome was unknown.            Concomitant medication information was not reported.  The patient experienced an eye stroke making him blind in the left eye and developed micro emboli from the Pfizer shot.  Treatment information was not reported.  The patient's next door neighbor suffered Bell's palsy.   This case was linked to US-MODERNATX, INC.-MOD-2023-745092, US-MODERNATX, INC.-MOD-2023-745094 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745092:Same Report US-MODERNATX, INC.-MOD-2023-745094:Same Report
swelling and itching to palms of hands/feet as well as angioedema of upper lip
PATIENT WAS DIZZY RIGHT AFTER THE SHOT, ALMOST FAINTING , WAS BREATHING BUT MENTIONED DIFFICULTY BREATHING WITHIN A COUPLE OF MINUTES. IN 5- 10 MINUTES RECOVERED AND GOT UP BUT WAS TAKEN BY EMERGENCY RESPONDERS
2 days after immunizations, he started to get itchy blisters on the forearm of the side he got Shingrix, so he thought it may be because of the vaccine.  4 days later it is still itchy and blisters.
Starting that evening fever of 101.3, vomiting, diarhea.  Her family doctor recommended fluids and rest and the symptoms stopped after a day.
The MMR was administered via intramuscular injection in the left deltoid.  The error was realized within 1 hour of administration and the patient immediately notified.
Pt had significant swelling, erythema, pain and tiny blisters at injection site 24 hours post injection.
patient called on the 6th of November saying that she had pain in her right side of her neck and she has a bit of swelling so I asked her to come to the pharmacy upon pressing of the right  side of her neck she said she felt pain . I said some people can have inflammation of the lymph node after vaccination and I suggested that she should call her doctor or go to a walking clinic . she did not want to do that but said she will text  her doctor. I called her the next day and she said the swelling is less
Flushing, throat tightness. Resolved with Benadryl. Tolerated second dose
Died right after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died right after the shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.      Concomitant Medication use information was not provided by reporter.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.  Treatment  Medication use information was not provided by reporter.  This case concerns a patient (demographics unknown) with no relevant medical history, who experienced the unexpected event of Death. The event occurred at an unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear if it was the first or second dose. The rechallenge was not applicable as event resulted in the death. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-365068 (Patient Link).; Sender's Comments: This case concerns a patient (demographics unknown) with no relevant medical history, who experienced the unexpected event of Death. The event occurred at an unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear if it was the first or second dose. The rechallenge was not applicable as event resulted in the death. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Began vomiting that night, has had continued loss of appetite. Diarrhea and rash also reported. Mom reported 4-inch rash 2 inches below Kinrix site.
started not feeling well 2-3 days prior to admission to local Medical Center. CC abdominal pain and weakness. Progressive epigastric and upper abdominal pain. Afebrile. No diarrhea or vomiting
Nurse assisting with mass vaccination clinic inadvertently gave vaccine in sq and not in deltoid muscle.  Vaccine was given half way down upper arm.   Large red area was noted on clients arm.
PATIENT HAD TIGHTNESS OF CHES - SHE SAID IT FELT LIKE THERE WAS A WEIGHT ON HER CHES
After oral administration in the patient's mouth, the patient stopped breathing for a few seconds, he then started having retractions and was tachypneic to 70-80s respiratory rate. His heart rate was 170 with pulse ox between 85-95%. We applied oxygen and called 911. Patient is being taken to Medical Center for further evaluation and treatment. I am concerned that patient may have aspirated the vaccine.
Injection hurt going into muscle. 3 hours later, felt like flu was coming on and the next day had severe muscle aches and body aches. 12 days later, still sore to touch and red.
12/19/2021 - Came to ED with Fever, cough, fatigue for 3-4 days. BP 157/78, HR 97, RR 20, temp 96.8, SpO2-95% RA. Covid positive in ED. WBC 13.1, CRP 12.3. Admit Covid pneumonia. Doxycycline and Ceftriaxone initiated in ER. Not candidate for steroids/baricitinib/remedsivir o2 sat above 95%. 12/20 - Overnight became hypoxic 87%. Started on 2L O2NC. Improved to 95%. Started Baricitinib and Remdisivir. Temp elevated 99.9. All other vitals WNL. D-dimer 242. Continuing with Heparin. 12/21 - Weaning O2-97% on 2L via NC. Cough continues, weakness, however able to ambulate to bathroom. Temp 97.9 12/23 - Now on room air saturating 97%. IV antibiotics stopped after developing diarrhea. Diarrhea improved. Additional information for Item 18:  12/24 - Completed covid treatment course, weaned off O2 and doing well. Discharged to home.
On 12/26/00, the child was admitted to the hospital. At the time of admission the child apparently had 2 lesions, though at the time of admission, the significance of the lesions was not noted. The child also had a fever of 102. On 12/26/00, the pt was placed on the combination of vancomycin and piperacillin/tazobactam. Cultures from the  central line were positive for Coag negative staph sensitive to oxacillin. A culture from the draining PEG grew methicillin resistant staph aureus. By 12/28/00, the child had developed at least 50 generalized lesions and was started on IV acyclovir. After 12/28/00, the child gradually developed small crops of lesions predominately on the extremities and in the diaper area. On 12/28/00, the child had a pediatric ID consultation. The physician noted that the child in general was alert and in no distress and was able to walk. Her height and weight were greater than 95% for her age. The child suffered from alopecia. Extraocular movements were intact. Red reflexes noted bilaterally. The sclarae are anicteric. Tympanic membranes were gray and had a normal light reflex. The pt had mild nasal congestion and a small amount of nasal discharge. There were no oral lesions and the pharynx was benign. Her neck was supple. The pt's abdomen was soft and somewhat distended, occasional bowel sounds were noted. A PEG button was in place and there was some crusting but no drainage. There were numerous vesicular lesions scattered throughout her skin and were located in the  extremities on the torso, on the scalp and most prominently in the area of the diaper. In total there were approximately 40-50 lesions which appeared to be at various stages. A few were crusted over, others had a more vesicular appearance. The pt's cranial nerves were intact. The pt was found to be VZV positive. As of 1/4/01, the physician indicated that the child is clinically stable and appears to be doing well. The physician indicated the child had a generalized vesicular rash, classic for varicella. It is probable that the varicella is secondary to the administration of the live viral vaccine to and immunocompromised child. A particular concern is the rising transaminases which appear temporally correlated with the administration of the vaccine. This may indicate a dissemination of the varicella. No further information is available. Follow-up info received from a physician on 4/24/01, indicated that as the pt was discharged from the hospital and has recovered from her experiences. He indicated that he is no longer following her as an outpatient. The physician reported that since 1/01, the pt has been followed in an outpatient clinic at the hospital for her autoimmune enteropathy. The records indicate she is doing well at home and has not been on any antiviral agents or had any sequelae from her adverse experiences in 1/01. The physician stated that according to hospital records, lesion specimens on 12/20/00 and 1/2/01 were positive for varicella; however, he could find no record that any PCR was done to differentiate between wild-type or vaccine strain VZV. No further information is available.
itching;eye redness w/discharge;throat pain, some swelling 4hr p/vax;peeling oral mucosa 2 days p/vax;
I was 5 weeks (nearly 6 weeks) pregnant.  I received the H1N1 vaccine on a Thursday and had a miscarriage on Sunday, just 3 days after getting the shot.   The day after I got the shot I experienced severe soreness in my body, specifically my back, neck, legs and arms.  The nurse who adminstered the shot said I would be sore, but I NEVER thought I would be THAT sore.  The manufacture of the vaccine have written warnings in the vaccine that pregnant woman should not get the vaccine, yet the government is urging pregnant woman to get the vaccine, even though there has not been sufficient testing on pregnant woman. 12/09/09 ED record received for DOS 11/22/09.  Pt. presented with vaginal bleeding, cramping.  States 5 weeks pregnant, G1 P0 Impression: threatened miscarriage; pregnant with vaginal bleeding
About 2 hours after booster was received on 12/30/2021 at 10:15am my heart rate rose to over 150+ bpm. Heart rate stayed above 150bpm until today 01/02/2022 in the am.
Anaphylactic shock after 10-15 minutes of the injection; Rapid heart rate of 166; shaking - mostly left arm and leg; super pale  lost all her color; voice was off; itching; Rash from the top of the neck, all the way down to her back; teeth were majorly chattering; bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction (anaphylactic reaction to sea food 15 years ago so) in 2006.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale  lost all her color), DYSPHONIA (voice was off), PRURITUS (itching), RASH (Rash from the top of the neck, all the way down to her back), CHILLS (teeth were majorly chattering) and HEADACHE (bad headache). The patient was hospitalized for 1 day due to ANAPHYLACTIC SHOCK. On 24-Mar-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale  lost all her color), DYSPHONIA (voice was off), RASH (Rash from the top of the neck, all the way down to her back) and CHILLS (teeth were majorly chattering) had resolved. At the time of the report, PRURITUS (itching) outcome was unknown and HEADACHE (bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: 166 (High) tachycardia.         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 15 year old female who on 10/16/06 was vaccinated with an IM HVP vaccine (lot 653978/0955F). On 10/17/06 the pt was sent home from school because she developed a fever of 102F and nausea. the physician reported that after 12 hours the pt recovered and returned to school the next day symptoms free. Additional information is not expected.