chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for COVID-19 on November 16, 2021.  EMS was called to Facility as the patient was hypoxic and confused.  Pt was transferred to the ED at Hospital, where she was found to be in hypercarbic respiratory failure.  Pt was placed on BiPAP.  Her respiratory status worsened.  The patient was intubated on November 24, 2021 through December 2, 2021.  Initial CXR showed bilateral pulmonary infiltrate consistent with COVID-19.  During the hospital course, the patient received dexamethasone and baricitinib.  Pt was also seen by Cardiology for bradycardia.  The patient had an echocardiogram done that showed normal ejection fraction with pulmonary pressure of 58 mmHg.  The patients hospital course at Hospital was further complicated by a urinary tract infection, treated with ciprofloxacin.  Since the patients extubation she had hoarseness and difficulty swallowing.  The patient was started on TPN for nutrition.  On admission to Hospital- on December 6, 2021 the patient was on Vapotherm with 40L and FiO2 of 65%.  The plan for while the patient was at Hospital was for her to continue on baricitinib and dexamethasone and Pulmonary was going to follow.  Pt was on TPN and a Doghoff was going to be placed and Tube feedings were going to start.  ENT was consulted for the hoarseness.  Pt was on a Precedex drip and the plan was to wean off of Precedex.  On admission to Hospital- the patient was a DNR/DNI.  On December 10, 2021 at 1620 the patient went Comfort Cares and on December 10, 2021 at 1707 patient expired.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient called to report redness, warmth, pain at injection site.
2 days after my shot, I noticed itching on my right arm (site of injection).  I ignored it as I usually have dry skin and it gets itchy.  The following day (04/12/2021), I noticed hives on the same arm.  I still ignored it but took Zyrtec and then 1 Hydroxyzine hydrochloride at night. Late night on 04/13/2021 my legs were extremely itching from the waist down to my ankles.  I couldn't stop scratching.  I had big hives all over my legs and some on my arms and body.  I took 1 Zyrtec but seemed to not help.  I took 1 Hydroxyzine hydrochloride and waited but the itching didn't go away.  I then took 2 Benadryl liquigels at around 3:30am.  The itching started calming down at around 6am and I finally fell asleep ~7am.
pt recv vax 25JUL97 & starting that evening pt noticed lt arm deltoid region becoming sore;26JUL97 the area became red & warm;
Swelling and pain in right deltoid area approximately 6 hours after injection. Patient reports pain at time of injection. Pain and swelling getting worse. Nurse said to ice down arm and take TYLENOL.
After first vaccine on March 15, I only had arm pain at injection site, but I started having pretty regular ringing in my ears, mainly in my left ear and for a very shorty duration each time it occurred. After second injection, I had pain at injection site shortly after injection that became much more intense and moved to my bicep the next morning. On the first day, I also felt tired and unable to concentrate, which became more severe on the second day before subsiding on the third. On the morning of the second day, I began having random, brief pinching pains in different parts of my body. These have occurred randomly since that day, at most 10 times a day or so, primarily in neck, arms and legs. I had a fever of 100.2 on the evening of the second day. The ringing in my ears is now very quiet and high pitched, but more or less constant and in both ears. Whenever it is quiet, I hear it or if I pay attention when it is not quiet, it is still there. I noticed the constant ringing yesterday morning (April 17) and it has persisted.
Patient was given 0.3 ml dose; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental underdose of vaccine.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient was given 0.3 ml dose of the COVID-19 vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  At the time of this report, the outcome of the event (accidental underdose) was recovered/resolved  The reporter did not assess causality for the reported event.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of Accidental underdose with mRNA-1273 (lot # unknown) without associated adverse events.  The patient was given 0.3 ml dose of the COVID-19 vaccine. The events occurred the same day as the first dose of mRNA-1273.  Event reported as resolved.
This spontaneous report was received from a Nurse refers to a 10 months old patient of unknown demography. The nurse reported that on an unknown date in January 2011, the 10 months old patient was vaccinated with the first dose of VAQTA (Strength: 25/0.5 U/mL) 0.5 ml doe (route was not reported). On an unknown date in August 2011, the patient was vaccinated with a second dose of VAQTA (0.5 ml) (route was not reported). No adverse events were reported. No further information was provided. Additional information has been requested.
has been sleeping all day; warm to touch (but had not checked temperature); significant headache; fatigue; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This nurse reported events for three patients. This is the third of 3 reports.    A 19-year-old male patient received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) (lot # CM1497), via an unspecified route of administration at single dose on 08Jul2020 for immunisation. The patient medical history and concomitant medications were not reported.   On 08Jul2020, the patient experienced warm to touch (but had not checked temperature), significant headache, fatigue. On 09Jul2020, he has been sleeping all day. The outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
A few hours after vaccine, patient reports developing bilateral red hot rash on neck and bilateral upper shoulders that felt like severe sun burn.  Over the next 24hrs, symptoms abated/resolved
Body Aches; Massive Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches) and HEADACHE (Massive Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Body Aches) and HEADACHE (Massive Headache). At the time of the report, MYALGIA (Body Aches) and HEADACHE (Massive Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a pharmacist concerning a patient who contracted shingles after close contact with individuals that had received ZOSTAVAX (Merck) (0.65ml, SC, one time shot). It was unknown if the patients sought medical attention. At the time of the reporting, the patient's statuses were unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient received an incorrect teen dose of 0.3 ml pfizer vaccine vs a correct dose of 0.2 ml pediatric.  this was identified almost immediately, and this patient stayed to be observed following receiving this vaccination for 30+ mins. no adverse reactions noted during the observation time.  Patient' PCP was consulted who instructed parents re: potential reactions and to watch the patient closely for the next 24 hours.  MD/PCP told parents to call us at any time if concerned, and nursing followed up with parent about patients status this AM (9:30AM). Parent reports no reactions.  message from nursing reiterated that parent can call at any time including over the weekend with concerns
within 24 hours of (unknown brand) influenza vaccination, my mom felt weak and dizzy - "very weird" most of day - she just made it to the next room to a chair and would have fallen to the floor but the chair broke her fall - she spun the easy chair completely around, did not pass out by would have fallen she was so dizzy. I do not know which specific flu shot she got.
Tinnitus development, high pitched, about a week after the first dose. Has not subsided yet.
next day got severe chills, 104 fever, voice left from coughing, barely could walk, severe headache, eyed hurting, and wheezing: sinusitis, pharyngitis
Hives all over body. Treated with OTC antihistamines, oatmeal creams, oatmeal soap, and cold compress. Appear on contact. Still ongoing without much improvement.
lost my sense of smell and tested positive for Covid; lost my sense of smell and tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The content of a post was noted that on Dec2020, "Got mine! And in a stroke of weird ironic awfulness, lost my sense of smell and tested positive for Covid later that day....If only a month sooner! Thank you for creating this vaccine. I know it had nothing to do with my diagnosis!". The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. Sender's Comments: The events drug ineffective and COVID 19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on the short temporal relation between vaccination and onset of events.
lymphadenopathy rt axilla found incidentally on US  Narrative:  Per note 2/15/2021 030M20A 1st vaccine lymphadenopathy rt axilla found incidentally on US. Repeat US 5/6/2021 No Medications   Other Relevant History:
high temperature (102 at one point); severe headache; This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included rosacea and psoriasis both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. The patient experienced high temperature (102 at one point) and severe headache on an unspecified date. The patient underwent lab tests and procedures which included body temperature: high temperature (102 at one point) on an unknown date. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 20 minutes after receiving the shot I got drowsy. About 30 minutes to an hour later I started having mild stomach cramps similar to menstrual cramps. I later found out I had menstrual bleeding (about 2:30 PM). This was unnatural for me because I have an IUD and have had it for 9 months, so I haven't been getting PMS like cramps or my cycle for the past few months.
Pfizer 8/5/21, 8/25/21. Positive on 12/4/22
12/11/03: Tetanus shot given. 12/12/03: Onset rash at site (left arm) along with tenderness. 12/15/03: Pt seen.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 13-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804105 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Fine hair in 2 cm oval pattern on each thigh where vaccine was administered 3 months previous. By history both areas had bruises after the vaccine.
Dizziness, aphasia with pulse drop to 30s. went to ED and found to be in ventricular bigeminy without cause found. had heart monitor put on Jan 11-13 which showed SVT 38% of the time.  I was on a heart monitor in the summer because I had issues with PVC after the birth of my child in July and I was in PVC 7% of the time then.   I am planning on taking the second covid vaccine but am uncertain if I should premedicate with something beforehand
Diabetic; pregnant; last full meal 17 hours ago. After injection, felt numbness and heaviness in right arm. BP: 110/62; pulse: 68; respiratory rate 16.
Pt recvd 3 doses of Engerix-B & pt is pregnant; estimated due date 6AUG92;
Woke up around 3:30 am on 02Apr2021 with a rapid heart rate; rush through her body from feet to head, very rapid heart rate (fluttering); tongue-tingling; This is a spontaneous report received from a contactable nurse (patient) reporting for herself. A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8733), via an unspecified route of administration, administered in right arm on 01Apr2021 08:45 (at the age of 63-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included exercise-induced asthma, SVT (Supraventricular tachycardia). Concomitant medication included sotalol. The patient previously took ciprofloxacin and diazepam (VALIUM) and had allergies to both. Approximately 5 minutes after receiving vaccine on 01Apr2021 (08:50), the patient experienced a rush through her body from feet to head, very rapid heart rate (fluttering) which lasted approximately 1min, tongue-tingling which lasted approx. 8 hours. Woke up around 3:30 am on 02Apr2021 with a rapid heart rate. She notified her PCP and cardiologist's office that morning. There was no treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event tongue-tingling on 01Apr2021 16:50. The outcome of the event rapid heart rate was not recovered.; Sender's Comments: Based on the information currently available and known vaccine safety profile, the causal association between the event of a rush through her body from feet to head, very rapid heart rate (fluttering) is assessed as unrelated to the usage of the vaccine BNT162B2 and more likely due to the possible contributory effects from patient's medical history and/or concomitant medications. 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.
I was give the vaccine 7pm at night and woke up the following morning and started to feel tingling from my elbows to finger tips.   It felt odd but no other symptoms.  I was at the grocery store and while reading the label of a mustard jar I inadvertently dropped it which was also odd.   This was 2 days ago and at the time it seemed like a harmless mild side effect but now that I see incidence I'm reporting it.
Information has been received from a certified medical assistant concerning a 12 year old female patient with no medical history and no drug reactions or allergies who on 21-JAN-2010, was vaccinated with the first SC dose of VARIVAX (Merck) (lot # 665644/1205Y).  There was no concomitant medication.  On an unspecified date, the patient developed red itchy areas surrounding the injection site.  No lab diagnostics studies were performed.  At the time of reporting, the patient was recovering.  The patient sought unspecified medical attention.  The office was requesting a lot check.  A lot check has been initiated.  This is one of several reports received from the same source.  Additional information has been requested.
vomited once; Nausea; Stomach felt uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach felt uncomfortable), VOMITING (vomited once) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach felt uncomfortable). On 18-Feb-2021, the patient experienced VOMITING (vomited once) and NAUSEA (Nausea). On 23-Feb-2021, ABDOMINAL DISCOMFORT (Stomach felt uncomfortable), VOMITING (vomited once) and NAUSEA (Nausea) had resolved. Not Provided          She was not able to eat anything but crackers and water. The patient did not receive any concomitant medications. Treatment information was not reported.
Information has been received from a mother concerning her 18 months old daughter with no allergies who on an unknown date, was vaccinated with VARIVAX (Merck) (lot# not reported). Secondary suspect therapy included RECOMBIVAX HB (MSD, Lot # not reported). Subsequently the patient experienced seizures when she was only 18 months old. It was reported that the patient "developed a very high fever for up to 105 degree and she was not responding to us so we brought her to the emergency room". The patient was not admitted in the hospital and she was released the same day after her fever was stabilized. It was reported that after seizures, the patient started to show signs of speech problems when she was about 2 to 3 years old and she was enrolled in a special school. At the time of report, on 24-MAR-2009, her daughter, now 6 years old, was fully recovered and had no learning disability issues anymore. She was reading and ahead of her game. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Patient admitted to hospital with positive covid-19 breakthrough case.  Had a fall at nursing home.  90% room air at this time.
Client given saline instead of COVID-19 Pfizer dose. Re-vaccinated 4/24/2021 at 1440. Given ER8735 IM in left deltoid. Expiration 7/31/2021.
BODY ACHES; CHILLS; FEVER; HEADACHE PERSISTENT (ON  BACK OF THE SKULL AND FOREHEAD); This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: social alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-AUG-2021, the patient experienced body aches. On 12-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced fever. On 12-AUG-2021, the patient experienced headache persistent (on back of the skull and forehead). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on AUG-2021, and had not recovered from headache persistent (on back of the skull and forehead). This report was non-serious.
7 days after vaccine pt developed red rash at injections site.  Rash is persistent one week after onset.
The vaccine was administered on Jan 4, he was healthy - no high blood pressure or cholesterol - not sick at all. He had seizures Jan 9th - almost died - then broke out with mild shingles on his back.
Approximately a week after vaccine, I noticed abnormal hair loss from my scalp. Shedding quite a bit of hair. I am a licensed cosmetologist. This amount of hair loss is atypical for me.
Systemic: swelling of fingers/hand-Medium, Additional Details: as detailed by technician who was present-- patient reported fingers swelling during observation period. pharmacist on duty directed them to remain in observation area. after a few minutes, patient reported that swelling had improved, stated that at the end of observation period they wished to leave. pharmacist advised them if any further adverse reaction occurs  (swelling, tightness in throat) to go to emergency room. patient then left observation area.
2-3 inch diameter region of redness, firm underlying tissue, mild swelling starting on Day 2; itchiness began Day 3. Symptoms still persist on Day 9.
Have had my menstrual cycle of heavy bleeding for 12 days, I was on my 4 day of a normal cycle (the day before it was supposed to end) when flow started back up  heavier then I have experienced in over 20 years.   I am still bleeding so heavily that I am unable to wear a tampon, and have to wake in the middle of the night to change an overnight pad because the feel of bleeding has woke me up.  Went to ER last night, had blood tests as well a pelvic and transvaginal ultrasound to rule out fibroid or any type of abnormalities that would cause it. Everything came back with no explanation and now I have to take a hormone, medroxyprogesterone 10mg for the next 10 days in hopes of stopping the flow.