chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Irregular heartbeat and dizziness from 0300 to 1000. No treatment other than rest, resolved on it's own.
Little soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little soreness at injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Little soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Little soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided.
Following morning after shots the left thigh swelled around in a 2 inch circumference around injection site, discoloration, and rash extended beyond covering majority of thigh. Rash also jumped and began to form in left groin area. Gave Motrin as recommended by a doctor 2 days later, 6/30, the following day, 7/1, was advised to give Benadril. Discoloration and swelling began to decrease. Area around injection site remained firm to the touch another two days, 7/3, but has decreased since and patient has recovered.
Myalgia, Arthralgia, Nausea Vomiting, Lightheadedness, Stomach Pain, Difficulty focusing Narrative:
No additional AE; HCP called to report a TE with VARIVAX. Improperly stored; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 28-SEP-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W018825, expiration date 14-JUN-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). No adverse effects reported. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
PANIC DISORDER; Felt lead like body; ANXIETY; FELT BAD; Tired and fatigued; throwing up all day; had a low-grade fever,; Contracted the COVID-19 virus; cough, cold; cold; migraine; Body felt like lead; Massive headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PANIC DISORDER (PANIC DISORDER) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012420A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer and Exposure to COVID-19 (twice).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced LIMB DISCOMFORT (Body felt like lead) and HEADACHE (Massive headache). On 16-Jan-2021, the patient experienced COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PYREXIA (had a low-grade fever,). On 17-Jan-2021, the patient experienced VOMITING (throwing up all day). On 18-Jan-2021, the patient experienced FATIGUE (Tired and fatigued). On an unknown date, the patient experienced PANIC DISORDER (PANIC DISORDER), DISCOMFORT (Felt lead like body), ANXIETY (ANXIETY) and FEELING ABNORMAL (FELT BAD). At the time of the report, COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine), DISCOMFORT (Felt lead like body), FEELING ABNORMAL (FELT BAD), LIMB DISCOMFORT (Body felt like lead), PYREXIA (had a low-grade fever,), HEADACHE (Massive headache) and VOMITING (throwing up all day) outcome was unknown and PANIC DISORDER (PANIC DISORDER), ANXIETY (ANXIETY) and FATIGUE (Tired and fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Antibody test: 250 (Inconclusive) Antibodies (results on 07-FEB-2021).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to have her second dose of the vaccine on 04-Feb-2021. She was tested positive for COVID and the nurse advised her to wait for 3 months. She was concerned whether she could take vaccine or not as she has developed antibodies for COVID.  No concomitant product use was reported  No treatment information was provided
I don't have any medical issues. 3 days after my first dose, I stopped feeling when I had to pee. I also wasn't feeling when or if I had to poop. Pee started leaking out. I did not feel like I had to pee (this how I first noticed). All tests ran came back ok. No UTI or anything showed in bloodwork. About a month later I started feeling again off and on. Then seemed to get better more and more. So I decided to get my 2nd dose Pfizer 12/19/2021. I hope it doesn't started again or anything. I have appointment with the urologist Jan 17, 2022.
Patient c/o itchiness in her face. No rash noted. No sob noted, BP WNL. Administered 25mg diphenhydramine per standing house order. Provider on-site notified. Instructed staff to watch patient for an extra 15 min. Patient felt okay and went home after 15 min.
I had a bad sore throat, I used a home COVID-19 test, it showed, I was positive. I waited four days before I called to have my telehealth visit. He advised me to use MUCINEX DM, stay hydrated, watch for worsening signs. I had waiting too long to call and get the PAXLOVID. I was feeling myself within two weeks.
felt like she was kicked; chill that went from the back of neck to head/chills; aches in the muscle; second dose on day 25; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 25), FEELING ABNORMAL (felt like she was kicked), CHILLS (chill that went from the back of neck to head/chills) and MYALGIA (aches in the muscle) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 0L6l20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, METOPROLOL and AMLODIPINE for Hypertension, ASCORBIC ACID (VITCEE), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMIN D NOS, POTASSIUM and MAGNESIUM for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 25). On 26-Jan-2021, the patient experienced FEELING ABNORMAL (felt like she was kicked), CHILLS (chill that went from the back of neck to head/chills) and MYALGIA (aches in the muscle). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 25) had resolved. At the time of the report, FEELING ABNORMAL (felt like she was kicked), CHILLS (chill that went from the back of neck to head/chills) and MYALGIA (aches in the muscle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Patient was given Menveo 0.5 ml on the Left Arm By MA on 8/20/2019 at 11:58 AM.  Patient was only given liquid component of the vaccine. Medical assistant did not reconstitute the liquid component with the powdered vaccine.  Menveo Lot# AMVA152A NDC-58160-955-09 Exp-07/31/2020 Manufacturer- GlaxoSmithKline
Redness and induration 1CM below the injection site 2x4cm. Wheal and flare appearance. No other findings or symptoms. Given 12.5mg of Benadryl PO with some improvement over 15 minutes.
the patient received two doses of Fluzone High Dose Quadrivalent vaccination within 1 hour on the same day; Initial information regarding this unsolicited valid serious case received from other health professional on 11-Dec-2020.  This case involves an 80 year old female patient with dementia who received two doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within 1 hour on the same day (extra dose administered).  Relevant past medical treatment, vaccination details, concomitant medications and family history were not provided. No other vaccines were administered. Medical history includes ongoing dementia.   On 11-Dec-2020, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ512AA, expiry date- 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic and again with another dose of 0.7 ml within 1 hour on the same day (extra dose administered).   It was reported that after receiving the vaccination the patient was then supposed to go to the lab, however she started to go home because she suffered from dementia, so they called her back and redirected her to the lab. The patient then went back to the clinic again requesting a flu shot even though she just received one. The original nurse that provided the injection, went to lunch and another nurse gave the patient another Fluzone High Dose Quadrivalent. The caller would like to know how to proceed as far as caring for the patient.  It was a case of actual medication error due to extra dose administered.  Relevant laboratory test was not reported.
The shot didnt work for me/Suspected vaccination failure; The shot didnt work for me; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that the shot does not work for him/her so the patient was taking Valcyclovir one tablet everyday and was doing very well. The patient stated about other person that it might as their doctor about that. He/she was sorry to hear about those issues experienced by other person. Additional Supportive Information: This case was conservatively considered for the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming the targeted event were unknown at the time of reporting. The follow-up would not be possible as no contact details were available
Prior to getting my vaccine I decided to pre-medicate about 30 minutes' prior with 50mg of Benadryl.  I received my second Covid Vaccine on Thursday 2/4/21.   After waiting about 25 minutes, I started to have tightness in my chest and coughing.  I notified staff.  They took me back to the observation room with a nurse.  At about 28 minutes, voice changed very raspy, chest tightness worse, I could not stop coughing and a very mottled rash on the arm of injection.  I was kind of out of it, like wanted to answer questions but really had to think about what I was trying to say and hard to find the answers.  They immediately took me to the ER where the doctor ordered and nurse administered Epinephrine....cont
Broke out with small, dry. itchy  rashes over the body.  I was told it was PITYRIASIS ROSEA
The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.; underage patient received Moderna COVID-19 Vaccine; The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received Moderna COVID-19 Vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received Moderna COVID-19 Vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received Moderna COVID-19 Vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Storage condition at the time of the excursion was refrigerated; lot number and expiration date were unknown; maximum or minimum temperatures reached was unknown; excursion duration was reported as from 12-Jan-2021 to 22-Apr-2022 and the date when the vial(s) were moved from freezer to refrigerator were unknown. This error was discovered this in April 2022.  With these error condition, the patient received the possible 1st dose on 23-Apr-2021 and possible 2nd dose on 26-May-2021.  No treatment information was provided by the reporter.
Ran low fever for about 15 hours, and on 03/14 noticed a series of raised rash/bumps around injection site. Rash still present, and site still tender on 03/15/21.
POSITIVE SWELLING REDNESS LEFT DELTOID AND WARMTH SINCE IMMUNIZATION. TREATMENT WAS GIVEN KEFLEX AND BENADRYL.
Patient presented to ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The first ED visit to admission was 3/17/21. She also presented to ED on 4/7/21 and 4/17/21. On 4/17/21 she was admitted and is currently hospitalized ever since.
Information has been received from a physician concerning a female in her 50's with diabetes who "one year ago", was vaccinated with her first dose of PNEUMOVAX (Lot #, site and route not reported).  One day after receiving the vaccine, the patient experienced hives, fever and a rash.  The patient sought unspecified medical attention.  On an unspecified date, the patient recovered from hives, fever and rash.  No additional information was provided.  Additional information has been requested.
Ran low grade fever evening of immunization (Tues PM) & on Thursday temp rose to 104; pt was also fussy (no other symptoms apparent); mom took pt to MD on Thurs Nov 7.
bleed on her stomach; blood clot on her leg; A spontaneous report  was received from a consumer concerning a 69-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced blood clot on their leg/Deep vein thrombosis and bleed on their stomach/Gastric hemorrhage.  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.   On 14 Feb 2021, the patient had a blood clot on their leg for which the patient was hospitalized. While on treatment the patient had a bleed on their stomach. The patient was in ICU for 2 weeks and another week on a regular room. The event, bleed on their stomach, was considered life-threatening.  On 4 Mar 2021, the patient was sent to a rehabilitation facility and on 16 Mar 2021, the patient was sent to their home.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the events, blood clot on their leg and bleed on their stomach were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Critical details such as the patient's medical history, list of concomitant medications, diagnostic findings and hospitalization details are lacking. Further information has been requested.
ADULT DOSE OF HEPATITIS A WAS INADVERTENTLY ADMINISTERED TO AN 18 YEAR OLD CLIENT, INSTEAD OF THE PEDIATRIC DOSE LICENSED FOR THAT AGE.
The pt had lower back pain, difficulty walking and weight bearing. He did not have further complaints per daughter. Dx'd by Neurologist with Guillain-Barre Syndrome. The discharge summary states deep vein thrombosis, pulmonary embolism, and quadraparesis. A 60-day follow up report received 6/26/2003 adds: His muscles are approximately 80% of what they were before his 7 month hospitalization.
On 8/28/21 after patient had been fully vaccinated, Patient became COVID positive. On 8/30/21, her respiratory status declined and she was admitted to Hospital. On 9/18/21 while still admitted as inpatient, she declined and required mechanical ventilation and ICU care. On 9/22/21 case died.
Information has been received from a health professional concerning a 9 year old white male with developmental delay and no allergies who on 6/8/01 was vaccinated in the left thigh with a dose of varicella virus vaccine live (lot # 638649/1889K). There was no illness at the time of vaccination and there was no concomitant medication. On 9/22/05, the patient developed chicken pox breakthrough. Unspecified medical attention was sought. Subsequently, the patient recovered on 9/29/05. No diagnostic laboratory tests were performed. It was noted that the patient nor his sister had any adverse events following prior vaccination. A product quality complaint was not involved. No further information is expected. It was also noted that the patient's sister developed chicken pox after vaccination with varicella virus vaccine live (WAES0510USA06240).
faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received bnt162b2 dose 1 intramuscular in right arm on 13Feb2021 16:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient had known allergies to penicillin and shellfish. Other medical history was not provided. The patient's concomitant medications included atorvastatin, vitamin, fish oil, probiotic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient became faint, tired and had chills which caused mild diarrhea from 13Feb2021 05:00 PM. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient received the bnt162b2 dose 2 intramuscular in Right arm on 06Mar2021 01:15 AM (Lot number unknown) at single dose for COVID-19 immunization. The outcome of the event events was recovered.   Information on the lot/batch number has been requested.