chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient's liver function was getting better and patient's face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recvd vax;2aug95 devel gen rash about 8;md noted it looked like they may turn into lesions;
Couldn't taste; Lost any appetite; I'm kind of dizzy/light headed; my stomach seems like I'm gonna throw up; Couldn't smell; fever; Cough; The arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The arm hurt), COUGH (Cough), AGEUSIA (Couldn't taste), DECREASED APPETITE (Lost any appetite) and DIZZINESS (I'm kind of dizzy/light headed) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PAIN (The arm hurt). On 11-Aug-2021, the patient experienced COUGH (Cough). On 12-Aug-2021, the patient experienced AGEUSIA (Couldn't taste), DECREASED APPETITE (Lost any appetite), DIZZINESS (I'm kind of dizzy/light headed), ABDOMINAL DISCOMFORT (my stomach seems like I'm gonna throw up), ANOSMIA (Couldn't smell) and PYREXIA (fever). On 10-Aug-2021, PAIN (The arm hurt) had resolved. At the time of the report, COUGH (Cough), AGEUSIA (Couldn't taste), DECREASED APPETITE (Lost any appetite), DIZZINESS (I'm kind of dizzy/light headed), ABDOMINAL DISCOMFORT (my stomach seems like I'm gonna throw up), ANOSMIA (Couldn't smell) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included that Medicine for Pressure, Cholesterol, Arthritis.  No treatment information was provided.   This case was linked to MOD-2021-288160 (Patient Link).
Initial unsolicited report received from a consumer (patient's father) on 26 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiry date, site of administration: not provided) by intramuscular route on unspecified date in September 2015 and a dose of DAPTACEL (batch number, expiry date: not provided) by intramuscular route in the arm on an unspecified date. It was reported that the patient either received first and second dose or second and third dose (reporter was not sure about the doses). The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date in September 2015, following the first vaccination, the patient became febrile and his leg became swollen to 2x its size, after the next dose the patient became febrile, his arm became red and swollen at the injection site and the patient cried for four hours. It was reported that the patient required ER/doctor visit. Lab data and corrective treatment were not reported. On an unspecified date, after four hours patient recovered from the event crying, several days later the patient recovered from the event febrile, arm became red and swollen at the injection site. On an unspecified date, patient recovered from the event leg became swollen to 2x its size. List of documents held by sender: none.
Patient became dizzy, diaphoretic, and pale, she was advised to lay on the table and was given a cold juice box to drink.
Rash, pin point and red, began in antecubital space of left arm. Then spread body wide; itchy soles of feet. No wheezing.
tiredness achy from vaccine I believe unrelated to vaccine,  I have had a CT scan and message results from doctor said mildly enlarged lymph nodes, but none of them would necessarily be considered suspicious or abnormal.
pt recvd vax; 14 hrs later,devel "shakes";6pm had fever 105 & 34 hrs p/ vax had rash all over body;lasted 4-5 days;MD uncertain of etiology of rash & sxs;on f/u:MD stated pt awoke on 1mar86 w/ chills & fever & had tenderness lt arm;apap adm
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 11:00 as dose 1, single (Lot number: HD9874) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing); "PFO closure" (unspecified if ongoing); "sleeve gastrectomy" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "hip tendon repairs" (unspecified if ongoing); "knee revision" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrodantin, reaction(s): "Known allergies: Macrodantin"; Rosuvastatin, reaction(s): "Known allergies: Rosuvastatin". Vaccination history included: Covid-19 vaccine (Dose 4), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vaccination failure , Covid-19 and the use of suspect product cannot be fully excluded.
only side effect from the first one was a sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER COVID VACCINE, Solution for injection) via an unspecified route of administration to her left arm on 13Jan2021 10:45 (age at vaccination: 78-year-old) (Lot number: EL8982, NDC number: Unknown, No Expiration) as single dose for prevention. Vaccination facility type: Clinic. The patient's medical history was reported as none. Concomitant medications were not reported. Family medical history reported as none. The patient previously took flu shots and experienced sore arm at site (annual flu shots). The patient had the first one three weeks prior and the only side effect from the first one was a sore arm. It was sore for about 30 hours. That was on the left arm. She received it on 13Jan2021. It was the Pfizer COVID vaccine with Lot EL8982, No expiration. Time of day was 10:45. No relevant test reported. Outcome of the event recovered on an unspecified date in Jan2021.  Communication: Attempted to warm transfer caller to Pfizer Medical Information, however, due to extended hold time, caller opted to be transferred to hold place in the queue. Provided caller with websites along with phone, with hours of 8a-8p, Monday-Sunday.  Follow-up attempts are completed. No further information is expected.
had my first Shingrix shot 4-1-21; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st April 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received second shot, which led to incomplete course of vaccination. The patient's wife and patient thought that the got the second shot. The patient enquired could he go ahead and get the second shot.
Patient has not received second dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose).    No concomitant medications were provided. Patient received first Moderna vaccine on 28-Feb-2023 and she needs to get the second dose and it's their primary series. All of their vaccines expired on April 1st. Limited AE. Extended interval between primary series doses was greater than 1 month. No treatment medication was provided.
It turned into all red circle next day/ turned into red covid arm; It is still sore; covid arm; Rash at injection site that was 3 inch long circle; (Rash) itchy; Patient noticed pain in the whole upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), PAIN IN EXTREMITY (It is still sore), VACCINATION SITE PRURITUS ((Rash) itchy), VACCINATION SITE PAIN (Patient noticed pain in the whole upper left arm) and VACCINATION SITE RASH (Rash at injection site that was 3 inch long circle) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN (ADVIL HEADACHE & MIGRAINE) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient noticed pain in the whole upper left arm). On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS ((Rash) itchy) and VACCINATION SITE RASH (Rash at injection site that was 3 inch long circle). On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (covid arm). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (It is still sore). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (It turned into all red circle next day/ turned into red covid arm). On 05-Mar-2021, VACCINATION SITE PAIN (Patient noticed pain in the whole upper left arm) outcome was unknown. At the time of the report, VACCINATION SITE REACTION (covid arm), PAIN IN EXTREMITY (It is still sore), VACCINATION SITE PRURITUS ((Rash) itchy), VACCINATION SITE RASH (Rash at injection site that was 3 inch long circle) and VACCINATION SITE ERYTHEMA (It turned into all red circle next day/ turned into red covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. patient mentions "covid arm".   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Event reported-covid arm
Very sore left upper arm  still- 11 days post vaccination. Painful to put on and remove clothing from upper body. Some motions are A OK. Painful to sleep on.
patient was administered expired Vaqta; This spontaneous report as received from a registered nurse refers to an 8 years old male patient. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was not reported.  On 09-AUG-2020 (on Saturday), the patient was vaccinated with an expired dose of pediatric hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration and lot# were not reported, expiration date 24-JUL-2020), for prphylaxis.
Information has been received from an RN concerning a 26 year old male that while hospitalized for a splenectomy in 1996, was vaccinated with pneumococcal vaccine 23 polyvalent. Approx. 30 seconds later, the pt experienced a drenching sweat and visual disturbances. The pt was treated with Benadryl therapy. The physician felt that the pt had an allergic reaction due to the phenol component in pneumococcal vaccine 23 polyvalent. Upon internal review, drug allergy, was determined to be an "Other Medical Event". Additional information has been requested. In F/U the Physician reported that the pt's experience was reported to him by the pt and the event happened in another state and not at this physician's office. Further information is not expected. The code of drug allergy has been changed to anaphylaxis, a labeled event. Therefore, this report is no longer meets the criteria for expediated submission.
Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant stated that, the patient received dose of Flulaval quadrivalent season 2019-2020 either on 18th October 2019, or within the week afterwards. The patient experienced events either the day of vaccination, or the day after vaccination. The reporter consented to follow up. This case has been linked with case US2019207552, reported by the same reporter.
5d after vaccination arm pain, muscle weakness generalized, numbness/tingling hands and feet, leg cramps up at noc. Bowel and bladder UA Blood lab drawn, Medrol dose pak.
I had a low grade fever (101) , chills and fatigue. Three days later I developed a ringing in my ears that is still going on and driving me crazy. Tinnitus! I never had it before!!
Erythematous rash 9x10cm to L upper, outer thigh in area of L2 dermatome developed @ 24h after vaccines were given.   Nontender on exam.  Remaining exam benign.  Started on hydroxyzine 6mg  Q6h prn 01/26/23
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  09/09/2021 Is this your first or second dose- 3rd Dose Date of symptom onset - ? 09/09/2021 Symptoms - ? arm itchy and red x 3 days, and fever of 99.9 today 9/13/2021 Last day of work and shift - ? NA Home remedies- none Any improvement- Employee stated she had a fever of 99.9 at 2 am this morning but has had no fever since 10 am. Employee stated she has not taken any kind of fever reducing medication. Recommendation- Advised employee to continue to monitor for any additional symptoms and report them. Also advised employee to monitor for return of fever and use Tylenol and or Ibuprofen if tolerated to manage temperature. Advised employee to follow up with PCP is symptoms persist or worsen. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
1.  Severe Knee Pain in Right Knee area - I had had a complete knee replacement in that knee 07/18/2011 that started about a week following injection and lasted for approx 10 days.  Knee was really swollen, hot  and painful. 2.  Left arm ( Covid Arm)  I had my shot in the left arm with very little issues.  About 8 days after the injection my left upper arm at injection site became very hot, red, swollen  and itched.  the area was about 6 " in wide.  This lasted for approximately 10 days.
I had COVID in Feb 2021 - I was better, got the second vaccine and I have all the symptoms that you can have for a long hauler, from fatigue,  headache, intolerant to exercise, extreme muscle and joint pain, and can not walk but a few feet without being winded.  I was exercising 8-10 hours a week before the 2nd vaccine, my life quality is zero at this time.  I struggle to do the simplest of daily responsibilities, missed another day of work yesterday.  I have even considered not living, just can't do that to my mom.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of improperly stored ROTATEQ (dose was not reported) lot # L008054, expiration date 30-NOV-2016 orally. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 3/30/21 I awakened to several palpitations followed by b/p 157/107 and heart rate 62 bpm, I was extremely lightheaded. My normal heart rate is 80-90. This slow heart rate between 55-65 lasted for 2weeks. I made 4 ER Visits, multiple lab blood work including Troponin. Multiple Chest X-Rays, CT-Scan on Abdomen.  I saw 2 Cardiologist Heart Monitor and Echocardiogram. No explanation for the Bradycardia. Received second dose of COVID-19 Vaccine 4/12/21  now experiencing Tachycardia heart rate staying mostly between 90-105 even when laying down.
I   have been  having  body  aches  but they have all but disappeared but  the  tingling through out body still continues
Nov 14 @ approx. 9 pm-   extreme tiredness         Nov 15 @ 3am extreme tiredness, dizzy ,mild body aches,  low grade fever    Ongoing still @ 10:30 am as I report this to you.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-APR-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007594 and expiry date: 27-JUN-2015) which was improperly stored. Primary reproter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
28SEP93 pt presented to clinic states for few days prior felt as if was getting a cold & on arising today noted rash on face/arms/trunk; feels as if has flu; c/o generalized aching; heaviness of arms; sore throat;
Headaches, low neck pain, base of skull pain, lightheadedness, slightly dizziness, brain fog, tightness in ears, left ear seems to stop randomly.  No treatment assigned beyond neck PT that will start  3/31/21.  Condition has been experienced  for 2 weeks.
PREVNAR 13 was given in right arm at approximately 4:15 PM. Patient woke between 3 AM and 4 AM. Right arm was very sore and painful, and had a Parkinson-like tremor that was not present before. Doctor was contacted; he suggested the tremor would probably subside over the next few weeks. He checked it 2 weeks later - no change. Have had MRI  and X-ray with no diagnosis. Dr. injected shoulder joint with cortisone/lidocaine with no positive result. Now nearly 4 months later, the tremor is still present, and constant. It is debilitating, making it difficult to write, eat, etc. Have to hold the arm down with other hand to stop the shaking.