chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe sepsis with acute organ dysfunction due to gram-negative bacteria; given iv rocephin, later culture confirmed. PNEUMONIA managed for this, improved, sepsis resolved repeat cultures show no growth, back to his baseline, stable medically to dc after 4 days with this dc plan of care. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Began having episodes of racing heart in October 2021. Multiple times per day, unexplained. On 11/18/2021 had an episode of sustained tachycardia (heart rate up to 180's) and HTN (180/120). Presented to emergency department for this episode. No etiology identified. Continue to have multiple episodes of tachycardia throughout the day.  Cardiology appointment pending.
p/pt awoke from nap was shaking all over & acted as if was unable to get breath;arrival to office extremities shaking like a shiver but blue nail bed & oral cool clammy;T99.7, BP 112/58, P186;
Extreme fatigue 24 hrs post vaccine. Arm stiffness, soreness and red rash appearing 2-3 days post injection. Swollen armpit lymph glands and rash 2-3 days post injection. Stiffness is abating on day 4-5; rash and stiffness is still present on day but appears to be imptoving.
Fussiness, Stumbling and Unsteadiness within an hour of receiving the vaccine
About 5 minutes after receiving both vaccinations, the patient collapsed and was non-responsive. I had a technician contact 911 while I went to get epinephrine. When I returned to the patient (no more than 2 minutes later), the patient was alert, responsive, and oriented to date and location. the paramedics arrived about 10 minutes later and checked the patient's vitals. Patient was reported to have low heart rate. Paramedics wanted to transport him to the ER, but patient refused AMA
small seizure kind of things where her body shakes/would wake up to shaking; This spontaneous case was reported by an other and describes the occurrence of TREMOR (small seizure kind of things where her body shakes/would wake up to shaking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (small seizure kind of things where her body shakes/would wake up to shaking). At the time of the report, TREMOR (small seizure kind of things where her body shakes/would wake up to shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.
no additional adverse event; VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a physician concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 21-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W017552, expiration date: 01-JUN-2024, administered as prophylaxis (strength, and route of administration were not provided).  It was reported that the vaccine was administered after a temperature excursion at a temperature of 28.2 Fahrenheit degrees for 1 hour (product storage error). No previous temperature excursion or additional adverse events were reported.
I woke up at 2am with a very rapid heartbeat (fastest I've ever felt). It made me nauseas, like I was going to throw up and went on for about 3 hours. I had to pace around my apartment to try and get my heart to slow down.
This spontaneous report as received from a registered nurse via company representative refers to a 15 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 28-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. The vaccine was purchased with private pay/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
6PM 4DEC felt hot, facial flushing;5DEC97 6AM rash around waist, lt ear & neck; 830AM seen on OHS-DPH given 9AM;3PM appt w/PCP;6:28 ER wheezing, rash spreading, facial swelling;
After she received shot on 04/01/2019 she got reaction on 04/04/2019 on her right Arm. Its swollen  with pain and red inflamed big bruise . she taking Advil and rubbing Ice as of Today 04/11/2019 she is doing better and swollen is down and less pain according to her.
Staff gave an expired vaccine/did not check the vaccine expiration date. Response to question 6: Vaccine was moved to another building/fridge without notifying vaccine coordination (reporting person). I though vaccine had been used when I went to pull it. Age of patient at time of event: 20 years.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX (lot # J001005 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 44.5 hours. On 26-JUL-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Large rash that developed 8 days after the injection. Rash went away after 2 weeks but has left a scar White, Dry tongue that has developed 8 days after injection. Similar to Oral Thrush. This has not gone away after 3 weeks
T103; several vomiting episodes, shaking, lt arm sore & red; Seen @ Hosp; Rx w/suppository for fever; Advised not to receive any further pertussis vax;
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (well controlled hypertension).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.  No concomitant medication was provided.   This case was linked to MOD-2021-337525, MOD-2021-337574 (Patient Link).
administered an expired vaccine to 1 patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to 1 patient.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to 1 patient.). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to 1 patient.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
At 0950, approx 15 minutes after vaccine, patient began to feel itching in her mouth, her heart racing and "hard to breath."  Patient immediately tended to, pale in color, but awake and oriented, reports she's feeling like she's in a fog, brought to exam room from observation area.  Vitals assessed at 0953; HR 109, SpO2 98%, BP 180/70, RR22.  Patient reports that itching resolved but began to have a metal taste in mouth lasting about 5 minutes.  Slowly patient began to feel heart feeling improving, c/o shortly of feeling cool in arms but while on exam table semifolwers symptoms improved.  0959 vitals: HR 92, SpO2 98, RR 18, BP 164/74.  1005: HR 88, RR 17, BP 162/70, SpO2 99.  No signs of angioedema, lung sounds CTA throughout course of symptoms.  At 1005, patient reports she still feels a little in a fog, but otherwise feeling better, color improved.  Patient declined transportation to hospital.  No signs of anaphalxisis and return to observation area where she sat for approximately 10 more minutes without issue.  patient advised that at this time safe to get 2nd dose, inform anyone giving vaccines in future of hx of this event.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was  reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 09-JUL-2016 and 2) 11-NOV-2016. [These dates were as reported. No details reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately August 2016 (it was reported that vaccines were administered on 22-AUG-2016, 23-AUG-2016, 24-AUG-2106 and 25-AUG-2016, but it was unknown which patient received doses on which date), the patient was accidentally vaccinated with 2 doses of RECOMIBVAX HB, intramuscularly, lot # M023892, expiry date 17-SEP-2017 (strength, dose and site of administration were not reported). No adverse reactions were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Administered more than six hours after the initial puncture of the vial by 16 minutes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered more than six hours after the initial puncture of the vial by 16 minutes) 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) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered more than six hours after the initial puncture of the vial by 16 minutes). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered more than six hours after the initial puncture of the vial by 16 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs.
chills, shaking uncontrollably then skin on fire, sensitive to touch, severe sweating, headache, pressure on chest. rapid heart beat,  body aches
Fatigue, irritability, difficulty concentrating. Nausea around 8pm. Soreness at injection site 9pm. Body aches. Woke up around 1pm itchy, took allergy pill. Soreness in arm increased. Extreme fatigue, slept until 1pm. Headache, fatigue, sore arm, body aches.
This is a spontaneous report from a contactable pharmacist. A 92 years old female patient (weight 68 kg, height 157 cm) received PREVNAR13; lot number J77185, expiration date APR2016; NDC number 00005-1971-05) on 03OCT2014 at 0.5 ml single, intramuscular. Concomitant medication included high dosage of a flu shot (unspecified) that was received for immunization at PREVNAR13 vac time (not further specified). On unknown date, a couple days before the report, the patient began to e experience soreness, redness and warmth at PREVNAR13 vac injection site. The site was about 3 inches of redness and it was sore and warm to touch for about a week. The events redness and pain were not resolved, the event warm to the touch was resolved with sequel . Pharmacist stated that she was not the one who administered the vaccine. Causality among the events and PRENAR was not provided as related. Follow-up (19NOV2014): Follow-up attempts completed. No further information expected.
Patches of hives on arms, legs, and face. Mother first noticed at 0700 8/28/13. Feet starting to swell.
7 day post shot 2:  sore feet - could not stand up 9 days post shot 2:  vomiting, lethargy, severe chest pains, lymphopenia, low magnesium, low glucose, mildly elevated troponin
Dizziness; Fever of 102.9; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Fever of 102.9) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Fever of 102.9). At the time of the report, DIZZINESS (Dizziness) and PYREXIA (Fever of 102.9) outcome was unknown.            No concomitant and treatment information was provided.   Reporter did not allow further contact
The arm that was injected was sore for 1-2 days then went away; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on arm on Dec2020 at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported. It was reported that he received the Pfizer Covid19 vaccine about 2 weeks ago, and the arm that was injected was sore for 1-2 days then went away. He feel fine now, reported no other adverse events, intended to get his second shot, and does not wish to be further contacted. The outcome of the event was recovered.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Day after vaccine, achy, fever (low grade mostly but did go up to 102).  Extremely tired which continued for 2 more days. Fever & aches responded well to ibuprofen & Tylenol.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative and a contactable Other HCP. This Nurse reported similar events for 2 patients. This is second of two reports. A female elderly patient (over 65) of an unspecified ethnicity received PREVNAR 13, (lot M35761 Exp date May2017), via an unspecified route of administration on an unspecified date at single dose. The patient years ago received a vaccine and passed out. She was told it was likely due to egg component. Concomitant medications were not reported. The patient experience a large circular swelling hot to the touch several days after injection on an unspecified date with outcome of unknown. Follow-up (28Mar2016): New information received from a contactable Other HCP included: gender, medical history. Follow-up(22May2016): Follow-up attempts are completed. No further information is expected.
Pain in the site of infection; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3248) via an unspecified route of administration on an unknown date (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no allergies, medical history or concomitant medications. On an unspecified date 8 hours after receiving her shot, the patient experience pain in the site of "infection" that had been mild. It was unknown if treatment was received for the event. The clinical outcome of pain in the site of "infection" was unknown.  No follow-up attempts are possible. No further information is expected.
made me sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "made me sick".  Additional information: Patient haven't had the chance to get it done. With her other vaccinations they made her sick and she don't have the time to be sick again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My arm muscle has been twitching for about 2 days straight at injection site. Not cramping, not painful anymore, no other adverse effects at this time, but my arm muscle right there is twitching like crazy on and off for a couple days now. Thought it was interesting and you might like to know. No idea why it started up a full two weeks after my second shot. Only had arm pain for about 3 days, no biggie.
Intussusception. 09/05/2008 MR received for DOS 8/6/2008 with DX: Intussusception reduced, suspect malrotation. Infant presented with 7-8 hr hx of intermittant crying and pulling the legs to the abdomen, increased sleep and later blood/mucus in the diaper. (+) gagging but no vomiting. PE (+) for an abdominal mass left to the umbilicus and dehydration. IS identified and reduced by barium enema. Pt was stable and to be transfered for further eval of abnormal BE. 9/08/2008 No further diagnostic tests done.
Extremely tired. Slept 5 hrs. Up for 1 hrs then slept another  3 jrs
I feel sick; Still lousy; My arm swelled and felt like it going to fall off; Asthma attack; I could not breathe, that was wheezing; Asthma attack; I could not breathe, that was wheezing; Asthma attack; I could not breathe, that was wheezing; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 72-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 22May2021 at 12:30 (Lot Number: EW0176, Expiration date: Unknown) as 2nd dose, single dose for COVID-19 immunization. The patient past Medical history included high blood pressure and irritable bowel syndrome not bothering her either. The patient previously received first dose of BNT162B2. The patient's concomitant medications included, yes lots of it, it will be on patient's record, because patient was on her medicines. On 23May2021, the patient experienced asthma attack, could not breathe, that was wheezing, on an unspecified date, experienced arm swelled and felt like it going to fall off, feel sick and still lousy. The first time all she had was 2nd day was her arm swelled and felt like it going to fall off, but patient got this 2nd injection yesterday and it really started bothering her but she woke up 4 this morning with an asthma attack and she have been using a nebulizer today, feel sick, really sick. The patient never had an asthma attack. Patient was breathing better but still lousy. The patient's lab data procedures included thyroids are little high, that was last month. Therapeutic measures were taken with nebulizer Ipratropium Bromide and Albuterol sulfate inhalation solution for asthma attack, could not breathe, that was wheezing. The outcome of the events asthma attack, could not breathe, that was wheezing was recovering, still lousy was not recovered and arm swelled and felt like it going to fall off, feel sick was unknown.  NDC number and UPC number, consumer stated, "All she had was the product number, the date of injection." )."
Patient with delayed vasovagal likely syncopal episode several hours after vaccine received:  "I wanted to let my Dr know that I had an incident on Friday.  Sitting at home talking with my wife ant two friends and started feeling "dizzy". They said I started shaking and head rolled back and I was out for a minute. I did not know anything had happened when I opened my eyes.  They insisted that I go to the hospital.  EMS came and tested me on the way to hospital- all tests good. Same at the hospital- you may have the results.   Not a seizure, no high blood pressure, maybe vaccine reaction? they weren't sure what it was, and wanted to keep me overnight and I said no thanks. Home about 5 PM I feel fine.  Please let me know if you want to go over.