chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Diarrhea 10/20/06 through 10/24/06; no treatment. Hives 10/28/06 through 11/06/06; oral Benadryl given by his mother. Joint swelling and pain 10/31/06 through 11/06/06; no treatment.
within hours she developed fussiness, fever, inconsolable fussiness, belly pains, vomiting x4
The only symptoms is weakness, congestion and sinus pressure. No fever yet and I have a mild cough. I've been taking over the counter medications.
Patient was seen in the urgent care for rash all over body. Vaccine was not given by us.
having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Fever 99-103 (103 at 15 hours post vaccine), fatigue, body aches, muscle cramps, cold chills from 15 hours post vaccine to current at 27 hours.
swelling in her right wrist; shingles; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (shingles) and JOINT SWELLING (swelling in her right wrist) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    The patient's past medical history included Unhappiness. Concurrent medical conditions included Rheumatoid arthritis.   On 10-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On 10-Apr-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced JOINT SWELLING (swelling in her right wrist). At the time of the report, HERPES ZOSTER (shingles) and JOINT SWELLING (swelling in her right wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatments were not reported. Patient reports after taking a break for Xelijanz XR, she does not see any changes. The patient also reports that prior to taking Xelianz XR,  she had swelling of the middle finger as reported as a huge mess.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Patient identifier observed and requested for more details. On 26-Jul-2021: Follow-up received contains no new information.
Information has been received for a registered nurse concerning a 40 year old caucasian male pt who on 8/6/99 was vaccinated IM via left deltoid with second dose of Hep B vaccine. On 8/6/99 following vaccination, the pt experienced headache with nausea, muscle aches and low-grade fever. Subsequently, the pt recovered from the episodes. It was indicated that the pt did not develop any adverse event following vaccination with the first dose of the vaccine. Two additional pt's were reported with similar symptoms following vaccination with Hep B. No further information is available.
got sick; Initial information received on 26-Nov-2020 regarding an unsolicited valid non-serious social media case from non-health care professional.  This case involves unknown age of male patient who got sick (Illness), while he received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient got sick (Illness, non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for sickness, at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported.
Arm/elbow - swollen over distal portion of triceps down to elbow.  Very slight erythema.  Area of swelling approx 7 or 8 cm in diam.  Mild tenderness in area of swelling.
Red & swelling around injection site. Applied ice pack, gave oral CLARITIN. Pt complained of itching. Triamcinolone spray applied, per v/o by Dr.
I got covid on 10/21/22.  After the shot, my arm was sore, I had slight chills, and was tired the next day.  I slept for a couple of hours.
Left thalamic infarct on 8/30/21. Right side paresthesia. Hospital stay 8/30/21 - 9/03/21.  Treated with Plavix 75mg, Aspirin 81mg, and Atorvastatin 80mg Full recovery within a month of the event.
Information has been received from a physician concerning an 11 year old pt who on 10/01/1996 was vaccinated with varicella virus vaccine live. On 06/09/1997 the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no Tx given and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. thirty nine other cases (WAES 0407USA01446 and 0409USA01855 to 0409USA01857 and 0409USA01859 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live . Additional information is not expected.
30 minutes post vax, the pt had flat, erythematous rash on abdomen and back. Also had congested cough and pale skin. Taken by mother in private car to ER. Given Benadryl at hospital and released.
Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide; Little sore - on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide) and VACCINATION SITE PAIN (Little sore - on arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide) and VACCINATION SITE PAIN (Little sore - on arm). At the time of the report, VACCINATION SITE RASH (Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide) and VACCINATION SITE PAIN (Little sore - on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Outcome of the events updated.
Parent reports migraine headache developed within hours of HPV#3. Headache persists 8 days after vaccine. He has returned to the office three times for evaluation of the headache.
Started with severe pain lower back radiating along sciatic nerve across buttocks over to bursa. Bright red swollen rash began after a few days. I went to ER on the day it appeared and was diagnosed with shingles.
Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, medical history or concomitant medication. On 21-SEP-2017, the patient received an unspecified dose of PNEUMOVAX 23 intramuscularly for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). Previous to the vaccine administration, the patient denied being vaccinated previously with PNEUMOVAX 23. Later that same day, the patient called informing that had received a dose of PNEUMOVAX 23 on an unspecified date in September 2016. No adverse effect reported.
pt recv vax & lab eval revealed elevated liver enzymes p/2nd dose of vax;
Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ, (date, route and dose not indicated). It was reported that the patient tested positive for rotavirus after receiving the vaccine and tested positive for salmonella one to two days after testing positive for rotativirus. No further information was available. Additional information has been requested.
38 WEEKS PREGNANT AND WHEN GOT THE SHOT; BAD CHILLS/TEETH CHATTERING; NAUSEA; HEADACHE; FEVER; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced 38 weeks pregnant and when got the shot, bad chills/teeth chattering, nausea, headache, and fever. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad chills/teeth chattering, nausea, and headache, had not recovered from 38 weeks pregnant and when got the shot, and the outcome of fever was not reported. This report was non-serious.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality product administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported  and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 61st of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Erythematous warm swollen area about 8" long and 5 1/2" wide over area left upper arm, area arm at shot site indurated about 2" diameter, no fever.
Patient admitted 1/10-17/2022 with suspected MIS-C.  Presenting symptoms: fever x4d,  conjunctivitis, chills,  HA, neck pain, back pain, and myalgias.  Met epidemiologic, clinical, and lab criteria for MIS-C. Treated with infliximab 10 mg/kg on 1/11/22 and IVIG 2 g/kg x1 1/11-1/12/22. Afebrile since completion of IVIG, also with rapid improvement in rash, diarrhea, conjunctivitis, and abdominal pain. Developed hematochezia on 1/11, continued intermittently until 1/14.
Information has been received from a registered nurse concerning a "toddler" female patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot# not reported) 2 ml. orally. The nurse stated that the patient had received the ROTATEQ (doses given and incident occurrence after which dose unspecified) and on unspecified date the patient developed the rotavirus and was hospitalized. The patient recovered and was discharged. No further information is available.
Patient felt her throat tightening (progressively getting worse), and her lips were tingling. On visual examination, her tongue looked normal and her lips looked normal. 911 was called immediately, and they were there within 4 minutes. They spoke with patient, who was alert and oriented, and able to walk to the stretcher.  No medications were administered to patient by EMS prior to leaving with patient.
Initially after the shot I just had a sore arm. Then Monday I started having fever and fatigue
Patient was given a Pfizer covid vaccine and then immediately passed out.  She was completely unresponsive and given 1 dose of epi and she responded to the epi.  Her dad was with her and said that she has anxiety issues and this is probably the reason she passed out.  EMS was called  and it was decided between EMS and Dad that there was no reason to transport her to the hopital as she was doing fine after being checked out by EMS;  Dad signed a waiver with EMS declining transport to the hospital.
High blood pressure (no previous history) to a max of 160s/100s and dizziness. Also reported high heart rate that would spike randomly, even at rest. Gradually improved after the next several weeks back to the normal range.
4 AM March 15 woke with severe headache, slight upset stomach, muscle aches, fever. Severe headache lasted until 4 PM. Lessened throughout night. March 16, less pain, but had discomfort. Headache was so severe I considered going to emergency room. I could not have driven there myself. Since it lessened at 4 PM, I decided not to go.
Filled out VAERS report at time it was found upon entering patient encounter in to pt EHR. At time of event, documentation was done through paper only. EHR was not available. Pt stated he had not been given a COVID vaccine in the past. Patient was given this vaccine. Later it was discovered he had record in system of 2 Moderna doses that had been given to him. One on 03/29/2021 and the second on 04/26/2021. After administered Janssen on this date, 5/12/21 patient was monitored and no adverse reactions were reported.
patient experienced: hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (patient experienced: hives) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concomitant products included OMALIZUMAB (XOLAIR).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (patient experienced: hives). At the time of the report, URTICARIA (patient experienced: hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information were not provided by the reporter.   Reporter did not allow further contact
bad arem pain / toes / were very painful/pain raidiated up my calve; toes / began to swell and itch and were very painful; toes / began to swell and itch; Numbness; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, swelling of feet, pruritus and numbness. On an unknown date, the outcome of the pain in arm, swelling of feet, pruritus and numbness were unknown.   It was unknown if the reporter considered the pain in arm, swelling of feet, pruritus and numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for this report. The age group was not reported but captured as adult as per vaccine indication. The patient received shingle vaccine Wednesday from the day of reporting, experienced bad arm pain tolerable but the next evening the toes on left foot began to swell and itch and were very painful.  Numbness and pain radiated up to calve.  The patient also asked was this a side effect.
Pt presented to medical squandron c/o large amount of swelling on right upper arm where she received her typhoid immunization. Also with four scratch-like marks above swollen area, approximately 3 inches long
Pt awoke at 0615 on 4/13/21 to use bathroom and became dizzy and fell, hitting her head and suffering T2,T4 vertebral fracture.
Pt described palpitations, irregular heartbeat, low blood pressure, fever, sore arm and sore armpit, swollen arm, bruise at injection site, swollen/hot/inflamed injection site.  Pt said she had the same reaction to her covid vaccinations too.  Told her to follow up with doctor and avoid getting the second dose for the shingles vaccine for now. Take a benadryl to rule out allergic reaction.  Pt went home quickly after getting the vaccine because she said she wasn't feeling good. Five days after getting the vaccine when she reported it to me, her arm was still bruised and red and swollen.  She had also picked up other medication that might have had to do with her low bp.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-AUG-2017, the patient was vaccinated with improperly stored PROQUAD lot # N010867, expiration date: 01-OCT-2018 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event was reported. Digital Data Logger was involved. The improperly stored PROQUAD experienced temperature excursion within temperature range from 36 Fahrenheit degrees to 46 Fahrenheit degrees for 21 days. There was no previous temperature excursion.
mom states child had temp 12MAY99 but okay 13MAY & 14MAY99;15MAY99 pt miserable & wanted to be held all day;16MAY pt still miserable & running temp later in day;dad thought spots on arms were bug bites;T102 to 105 & joint pain,v;chickenpox
No additional AEs; an expired dose of MMR-II was given to a 12 month old; This spontaneous report as received from a Nurse prescriber via a Company representative refers to a 12 month old patient of unknown gender.     No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided.  On an unknown date  in 2023, the patient was vaccinated with an  expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) expiration date: 26-FEB-2023 (expired product administered) for prophylaxis (dosage schedule, route, anatomical location and lot number and were not reported).  No additional adverse events were reported.