chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to an approximately 12 month old female patient. The patient had no medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On 22-FEB-2016, the patient was vaccinated with the first dose of M-M-R II Inj (lot# L013827 and expiry date 10-APR-2017) 0.5 ml, subcutaneously. On an unknown date in approximately February 2016, the patient experienced fever of 102 to 104 degrees and raised rash at the injection site which was hot. Patient sought medical attention-she returned to the office. Patient was treated with TYLENOL, MOTRIN and cold pack applied to the injection site. No lab diagnostics studies were performed. On 01-MAR-2016, the patient was doing better and had a slight fever. At the time of report, the outcome of events was reported to be recovering/resolving. Causality assessment was not provided. Additional information has been requested.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO ADVERSE REACTION WAS REPORTED DURING PATIENT INTERVIEW.
The next day after vaccine, my neck was very sore which was intense. My neck felt like a rock and was heavy. Symptoms lasted 2 days. It was very uncomfortable and painful.
Sometimes it itches on the body; Like red spots; Swollen; Inappropriate age at vaccine administration; Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots), SWELLING (Swollen) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). In 2021, the patient experienced MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose). On an unknown date, the patient experienced PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (Swollen). In May 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (Swollen) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided. It was reported sometimes it itches on the body, like red spots and was swollen and that sometimes it goes and come. The menstruation problems appeared after 15 days from the second dose.   Reporter did not allow further contact
Pt reported hives and dizziness approximately 1500pm on 10/30/08 after receiving vaccine on 10/30/08 AM. Took Benadryl by mouth and Benadryl cream to hives. Symptoms improved in approximately 30 minutes.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 72 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient tested positive to COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive to COVID-19) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Patient had no Medical Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy to antibiotic (unspecified antibiotics) and Blood pressure abnormal.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced COVID-19 (Patient tested positive to COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive to COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, SARS-CoV-2 test: (Positive) positive.         Patient concomitant medications included unspecified blood pressure medications. It was reported that patient received first dose of Moderna COVID-19 Vaccine on Jan 2021 via intramuscular route , second dose on Feb 2021, first booster on 25Oct2021 and second on Apr 2022. On 24Sep2022 (two days later), patient started to feel sore throat, cough and sneezing, and 4 days after the vaccine went to the doctor and tested positive to COVID-19. It was unknown whether patient experienced a similar event in the past. AE outcome was rebound, still ongoing and symptoms were same neither improved or worsened. Patient treatment included Paxlovid during 5 days but had a rebound from COVID-19 and symptoms were still ongoing.   This case was linked to MOD-2022-656141 (Patient Link).
This spontaneous report has been received from a medical assistant and an administrator and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measure on 24-JAN-2017 a temperature range, the same temperature frame for 3 hours (3 cycles), on 26-JAN-2017, for 4 hours (4 cycles) at the same temperature frame for a total of 8 hours. The medical assistant mentioned that the vaccine was exposed only for 1 hour and 30 minutes at a temperature as low as 33.1 °F, the other cumulative hours were at 34 °F. There was no previous temperature excursion. No adverse effects were reported, and product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008107: US-009507513-1704USA001786: US-009507513-1704USA001784.
Patient called the pharmacy on 1/7 to report that she noticed soreness and a nodule at the injection site from a PREVNAR 13 immunization that we gave the patient on 12/31. We advised the patient to continue taking anti-inflammatory medication and follow up with PCP if symptoms don't continue to improve.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:33 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications on use were not provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 03 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Breakthrough Case of COVID-19; a scratchy throat, Slight Fever and watery eyes. I went and got tested and it came back positive.
Stomach pain BP 119/90 Pulse 58 Resp 14 SpO2 97% RA
Severe abdominal and back pain starting at 7:20 May 25, 2021. No otc med worked to relieve pain. Could not get out of bed. Called pediatrician.
Patient is here today for a Tdap and did mention that she has an anaphylactic allergy to latex. This RN explained that the rubber stopper of the pre-filled syringe does contain natural rubber latex and asked Patient if she still wanted to receive this vaccine. Patient said yes, that she didn't think it would be a problem as it had never before been a problem with any other vaccines.   A few minutes after the vaccine was administered at 11:30 am, Patient said she felt like her tongue was starting to swell. At this time Patient's O2 sat was 94%, heart rate 82 bmp, respirations 16 per minute. Patient was alert and oriented. Patient said she wanted to walk to her car to get Zyrtec so that she could chew two of those in hopes of stopping the reaction. RN explained that the best way to stop the reaction is to administer epinephrine. Patient said she preferred to try the Zyrtec first. Patient chewed two Zyrtec around 11:35 am. Patient started to have difficulty speaking due to the swelling of her tongue. CNM came in to assess Patient . Per CNM, lung sounds were normal without wheezing. Vitals at 11:45 am were stable. Since the swelling of the tonge was not getting any better, this RN administered 0.3mg epinephrine (EpiPen auto injection Lot 0GM229 Exp Dec 2021) to the right deltoid at 11:45 am. This RN also called 911 at this time to request paramedics.   Another set of vitals was taken by CNM at 11:55 am; vitals continued to be stable. (The paramedics took the sheet of paper that had vitals written down on them before this RN could chart the exact vitals.) This RN does remember that Patient's O2 had improved to 97% after the epinephrine was given.   This RN strongly recommended that Patient do follow up testing with an allergist. This RN also recommended that Patient ask if there is latex in any vaccines moving  forward. Patient voiced understanding.   The paramedics arrived around 11:55 am and took over Patient's care. Patient ended up declining to go to the hospital for further evaluation and asked her sister to come pick her up.   The paramedics left at 12:15 pm and Patient left the clinic with her sister around 12:20pm.
pt recv vax 14APR97 & exp flu like sx the next day;pt missed one day of school;
Pt recvd Engerix-B & 19JUN92 exp diarrhea & extreme fatigue; lasted 4 days; tx tincture of thyme-seems fine;
patient was diagnosed as HPV positive; This spontaneous report was received from a physician, via company representative, referring to a 24-year-old female patient. The aptietns pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were unknow by the reporter.  On an unspecified date in 2010 (also reported as "9 years ago") the patient was vaccinated with a 3 dose regimen of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), intramuscular for prevention of human papilloma virus (HPV) (strength, dose, frequency, anatomical injection site, lot number and expiration date were not reported). It was reported that the patient was diagnosed as being HPV positive (human papilloma virus test positive). It was reported that the patient did not received treatment due to this event, and her laboratory diagnostics included a routine Pap smear (performed on an unknown date) but no results were provided for this exam.  At the time of this report, the outcome of human papilloma virus test positive was unknown.  The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the event was not provided.
Diarrhea; Super gassy/Passing gas; Bloated; Tummy was like big; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FLATULENCE (Super gassy/Passing gas), ABDOMINAL DISTENSION (Bloated) and ABDOMINAL DISCOMFORT (Tummy was like big) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Diarrhea), FLATULENCE (Super gassy/Passing gas), ABDOMINAL DISTENSION (Bloated) and ABDOMINAL DISCOMFORT (Tummy was like big). At the time of the report, DIARRHOEA (Diarrhea), FLATULENCE (Super gassy/Passing gas), ABDOMINAL DISTENSION (Bloated) and ABDOMINAL DISCOMFORT (Tummy was like big) had resolved. Unknown          Concomitant medications includes Pain medicine. Treatment medication reported includes Ammodium .   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR form added. Events outcome was updated.
I took the first shot, the side of my foot swelled up/ When I got the first shot of Pfizer side of my foot swelled up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EW0167, Expiry date: not reported) via an unspecified route of administration on 30Apr2021 (age at vaccination 50-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and kidney transplant from an unknown date and unknown if ongoing. Concomitant medications included tacrolimus (PROGRAF) taken for renal transplant and amlodipine taken for hypertension, start and stop date were not reported. On an unspecified date, patient stated that he was having real bad side effects, so he took the first shot, the side of his foot swelled up. Patient stated that taking Tylenol but its not working. The outcome of the event was unknown.
Administered PNEUMOVAX 23 9/21/15 pt tolerated well, pt called office 9/22/15 at 8:30am reported (L) arm stiffness and pain. Was advised to do warm compresses BID PRN pain 10-15 min each time and ok to take ibuprofen or TYLENOL. Pt walked into office 9/23/15 with c/o (L) arm pain, warm to touch, muscle pains, and redness to elbow. Pt was seen by Dr. and prescribed KEFLEX oral. Advised to use cold compresses, BENADRYL PRN and Ibuprofen PRN pain and to call PRN if not better or worse.
Fever - peaked at 106 on 1/30/2010 - seen in ER - no other signs or symptoms. Normal exam.  Afebrile by 2/1/2010.
IMMEDIATE SWELLING WITH INJECTION, SUSPECT HEMATOMA. ICE AND PRESSURE APPLIED.
Growth/ lump on left shoulder. Growing larger each year 3 yrs pain of shooting needles when movement in arm. Muscle relaxants, physical therapy.
Developed chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date,refer case US2021AMR001133). Concomitant products included valaciclovir hydrochloride (Valtrex).   On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced chills and fever. The patient was treated with paracetamol (Tylenol). On 3rd January 2021, the outcome of the chills was recovered/resolved. On 4th January 2021, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient developed chills and a fever.  On 03 January 2021, the patient was treated with tylenol  for chills and fever. The reporter stated that on 4th January 2021 she had a slight fever that has resolved. The reporter refused to provide any additional information and hunged up abruptly. The reporter did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001133:Same reporter
denies having any adverse reactions. Medication Administration Error:  received her first dose of Moderna on 3/12/21 and was told that she would receive an email from the to register for her second dose that was due on 4/9/21. A colleague  who is on a different vaccinating schedule than the subject of this report, was due for a second dose of Moderna on 3/26/21. This colleague shared the link to the 3/26 clinic with Pt. Pt DID NOT receive an email registration invite from the clinic held 3/26/21. However, when she received an email invitation to register for the clinic to be held on 4/9/21 (the date her actual dose 2 was scheduled), Pt notified the clinic via email that she had already received a second dose. Upon further investigation the clinic verified that Pt did not receive an email invitation from the clinic for the scheduled 3/26 dose. Also noted: Pt responded "NO" to Screening question "Have you had any vaccines in the past 14 days (2 weeks) including flu shot?", By answering No, the screening form did not get flagged.
This spontaneous report was received from a healthcare worker via company representative refers to a patient of unknown age. On 15-MAR-2015, the patient was vaccinated with ZOSTAVAX, dose 1. On 15-MAR-2016, the patient was vaccinated with dose 2 of ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Felt horrible, pretty awful; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful 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 feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient just got the shingles vaccine and felt horrible for several days. The patient never had have such a bad reaction to a shot.  The patient did not want shingles either, but the shot was pretty awful! The follow-up could not be possible as no contact details were available.
Spoke with pt. on 10-9-13. Pt. states on Mon. after rec. imms she remembers going to bed that night and waking up the next AM with a "violent" headache. So she went back to bed. Pt. states she doesn't remember anything until Friday. Pt. states her boyfriend, a paramedic, was with her the whole time and boyfriend stated she had cold chills and was unsteady on her feet. Pt. was not taken to ER/urgent care. On 10-9-13 pt. stated all symptoms had resolved.
Red and purple raised rash over bilateral back and right flank, dermatomal component, gradually fading over two weeks, not completely resolved
I had a very bad migraine like headache, severe dizziness, multiple episodes of vomitting for a whole day, Vision got a little bury. I felt sea sick and had to cancel my day at work and laid in bed until the next day and I was fine.
Parent called saying baby had welts on legs and back. Had given Tylenol after shots. Parent also called PMD who said watch him. Called pt's family at 1:00 PM and they said he was doing OK and welts were diminishing.