chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Really heavy period; Heart rate was really high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 07Nov2023, outcome "unknown", described as "Heart rate was really high"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Really heavy period". Additional information: Consumer stated, "I got the Pfizer vaccine for COVID on this past Tuesday (07Nov2023) and I am having some different side effects form that, I do not know if they have been reported before but I have my period and it is really heavy which is not normal and also the day I got my vaccine I have a really high heart rate."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
patient recieved already opened and stored vaccine at 51.2F for 1 hour and 16 minutes with no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA237576 and 2019SA237574 (same reporter).  This case involves a 5 year old male patient of unknown age who received vaccine IPV (VERO) [IPOL] and reported that vaccine was already opened and stored at 51.2 Fahrenheit for 1 hour and 16 minutes with no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  On 21-Aug-2019, the patient received 4th dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via unknown route in the left thigh.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sore arm. Headache. Dizzy 7pm same night. Didn't sleep well. Achy especially in knees and back. 3/7 am slight fever 100. Headache all day. Still sore arm.  Body ache, no appetite.
expired dose was given inadvertently by nurse to patient, no adverse event; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 18 month old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fourth dose, lot C5366AA  and expiration date 07-Feb-2020) via an unknown route in the left thigh on an unknown date.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
HEAD PAIN SHARP, PAIN IN CHEST FOR TWO DAYS, VIENS FELT LIKE THEY WERE GOING TO EXPLODE, FLU LIEK SYMPTOM, DRY COUGH , THROBBING HEAD
pt felt light headed and had to sit down he got sweaty and within approximately 30 minutes pt got up and walked out
Approximately 12 hours following the first dose I started to feel chills, headache, nauseated, fatigue, fever-101.2 F, intestinal issues, right arm pain, body aches.  The following day, I experienced the same, in addition to, extreme fatigue and dizziness upon standing and lower blood pressure. On Saturday, two days following, I experienced swollen lymph nodes in my lower neck and collarbone area, same side as the injection. I called my Dr. on Monday to ask them about it and they informed me to wait four weeks to see if they go down. It is now March 25 and I still feel headaches with neck tenderness and collarbone tenderness.
Had the shot...a few years later I had one giant shingle on my thigh/Suspected Vaccination failure; Had the shot...a few years later I had one giant shingle on my thigh; This case was reported by a consumer via media and described the occurrence of suspected 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and a few years later he/she had one giant shingle on his/her thigh. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available
Hernia, ventral incisional, with obstruction. ED visit to hospital admission. this visit was within 6 weeks of receiving the COVID vaccine.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received SHINGRIX for prophylaxis. In 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and injection site warmth. On an unknown date, the outcome of the pain in arm and injection site warmth were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in September 2018 or October 2018 and forgot about it because he has been working and busy. The caller also stated that after he got the shot, his arm was sore for about 4 days. It was also warm for a couple days or so at the spot where it was given. The patient was not sure how long after the shot it started. For tolerance to 2nd dose, refer case US2019065893.
Itching at injection site; Red bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red bump at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red bump at injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red bump at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Joint pain in lower and upper extremities radiating to upper torso affecting ADL. Denies paresthesia or respiratory distress.
Patient was inadvertently given a vaccination dose on 10/21/2022 from a vial which had expired on 9/30/2022. No adverse effects experienced by the patient to date.
I woke up in the middle of the night with the shakes, jagged headache pain, a small amount of body pain, and a general feeling of not quite well.  I got back to sleep after about an hour.  When I woke up the next morning I felt like I had been hit by a mack truck.  I was fatigued, had a headache and other bodily ache that included most specifically in shoulders, hips, fingers, and lower legs.  I slept most of that day due to the fatigue.  I felt somewhat better the next day, and was pretty much back to normal by the third day.  I had pain and redness at the shot site in my arm starting the day of the shot.  Over the next several days it was very sore and the redness spread out in about a 2 and 1/2 inch circle on my arm.  By the fourth day after the shot the pain was mostly gone.
Pt. felt light-headed and passed out ~5 minutes after flu shot administration. He passed out up front in the store and an ambulance was called. Pt. woke up and felt better after water. The EMT's then took him for an EKG and that is the last he was in our care.
Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Acute illnesses at the time of vaccination and up to one month before were given as none.  Previously administered products included for Product used for unknown indication: Janssen (Fully vaccinated with 1 dose) in June 2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Drug allergy (haloperidol allergy), Drug allergy (divalproex allergy), Hypertension, Type 2 diabetes mellitus, Bipolar I disorder, Anxiety disorder and Substance abuse. Concomitant products included LITHIUM CARBONATE from 28-Dec-2020 to an unknown date for Bipolar I disorder, METFORMIN from 17-Jun-2021 to an unknown date, SEMAGLUTIDE from 21-Sep-2021 to an unknown date and INSULIN GLARGINE from 17-Jun-2021 to an unknown date for Diabetes, LOSARTAN from 02-Feb-2022 to an unknown date for Hypertension, PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for an unknown indication.    On 05-Jul-2022 at 2:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Jul-2022 at 2:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received a booster dose of vaccine from a vial that had exceeded its 30 day working expiration. No adverse events noted at the time of reporting. Number of doses and vials were reported as 15 doses and 3 red cap vials.  Vial was initially stored in the refrigerator on 02-JUN-2022  The vial did not undergo any temperature excursions.  No treatment medication was reported.
pentacel was administered to a patient using only the dtap-ipv portion and not the hib component/ DTaP-IPV portion of PENTACEL being administered without the Hib component.with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 month few weeks old female patient who experienced pentacel was administered to a patient using only the dtap-ipv portion and not the hib component/ dtap-ipv portion of pentacel being administered without the hib component.with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) and rotavirus vaccine live reassort ORAL 5V (ROTATEQ) both for Immunisation.  On 21-Jun-2022, the patient received suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot UJ593AAA, expiry date, strength: not reported) via intramuscular route in the left thigh for immunisation.  On 21-Jun-2022, latency same day, pentacel was administered to a patient using only the dtap-ipv portion and not the hib component/ dtap-ipv portion of pentacel being administered without the hib component.with no reported adverse event (single component of a two-component product administered) following the administration of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.   Outcome Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
102 deg fever, chills, heavy painful chest, difficult breathing (felt like pneumonia) hives on arm at inject site. Extreme pain in arm. Lasted almost 4 days. Also had extreme weakness.
Swelling, bright red circle appx 4" in diameter and hot to the touch, pain, fever of 102 lasting 4 days then 99-100 for 3 additional days. Today is 3/23/2017 and she is still in intense pain, her arm is still swollen although the circle has gotten smaller and the redness is gone, the circle is darker than her normal skin tone.
3 days p/vax became very ill w/resp virus which lasted 14 days;14 days p/immun sx; small red measles-like dots all over body, no fever, inc general malaise;
Interchange of vaccine products; Anaphylaxis reaction; Throat and tongue started feeling itchy; Throat and tongue started feeling itchy; Felt like throat was closing up; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2023NVX-US-000000157 (Novavax).  A 54-year-old female patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen COVID-19 vaccine (dose number unknown, single), administration date: 27Mar2021, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 30Nov2021, outcome "unknown", described as "Anaphylaxis reaction"; THROAT TIGHTNESS (medically significant) with onset 30Nov2021, outcome "unknown", described as "Felt like throat was closing up"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Nov2021, outcome "unknown"; THROAT IRRITATION (medically significant), TONGUE PRURITUS (medically significant) all with onset 30Nov2021, outcome "unknown" and all described as "Throat and tongue started feeling itchy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had a really sore arm and after two weeks, a rash appeared in my abdominal area all over. It did not itch or burn but was just all over. Due to my history with hives I went to my allergist who said that it could have been an immune response from the vaccine. The provider indicated that it was not unsafe for me to get the next vaccine. It took a few days to resolve itself.
metallic taste; taste became intense,taste had worsen,tasted like nickels in mouth; unusual rash on chest traveling up to neck; injection site soreness; could not raise arm for 5 days; headache; sick to stomach; odd reaction; pervasive metallic taste in mouth; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth), DYSGEUSIA (metallic taste), ABDOMINAL DISCOMFORT (sick to stomach) and TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth) and ABDOMINAL DISCOMFORT (sick to stomach). On an unknown date, the patient experienced DYSGEUSIA (metallic taste), TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth), VACCINATION SITE PAIN (injection site soreness), LIMB DISCOMFORT (could not raise arm for 5 days), HEADACHE (headache) and RASH (unusual rash on chest traveling up to neck). At the time of the report, VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth), TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth), VACCINATION SITE PAIN (injection site soreness), LIMB DISCOMFORT (could not raise arm for 5 days), HEADACHE (headache) and RASH (unusual rash on chest traveling up to neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
I FELT FLU LIKE SYMPTOMS WITHIN A FEW HOURS. ACHY MUSCLES, EXTREME FATIGUE,  WOKE UP SHIVERING THAT NIGHT AND I HAVE REALLY BAD EAR RINGING
Dizziness, drowsiness, body aches and chills shown up hours after vaccination. Two days later (today) is bad cough.
Difficulty breathing, hoarseness, wheezing, weakness and sweats all night(one night). Continuing through Nov 1(today). Today feel 70%.
8/24/2016 Within in 15 minutes of vaccine developed fatigue, 2 hours later developed Bronchial burning. 8/25/2016 Woke up with swollen eyes and swollen lips. Took one dose of Claritin and swelling subsided.
PT HAD FEVER CHILLING AND GENERAL MALAISE ARM WAS INCREASINGLY RED AND TENDER-PT HAD CELLULITIS OF RT ARM REQUIRING ANTIBIOTICS IM AND PO
The patient developed severe hepatitis requiring hospitalization.  Other causes of acute hepatitis were ruled out.
Tightness in chest for about 2 days. Resolved All over body tingling for about 2 days   Resolved
After three days my injection site started swelling and itching  Now it's gotten worse and it's been 7 days.  I have a hot red swollen patch about the size of a half dollar that itches.
pt recv vax & BP bottomed out & pt passed out while fifth dose being given;pt exp yellow eyes, confusion, stomach upset, diarrhea, achiness, insomnia;
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (and localized redness at the injection after 1st dose, refer case US2018197797). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever and injection site erythema were recovered/resolved. It was unknown if the reporter considered the fever and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter indicated that he administered the first and second doses of the SHINGRIX vaccine to his sister. With both injections she experienced a fever and localized redness at the injection. The reporter did not consent to follow-up. The field representative was unable to provide additional information. The field representative reported three separate adverse reports from this reporter. This case has been linked with US2018197802 and US2018197775, reported by same reporter.
Patient was given a 4th vaccine of COVID-19 under the advisement of his Hematologist at.  This was due to having an Autologous Stem Cell Transplant. First Series doses were done on 1/22/2021 and 2/12/2021. Revaccination series was done on 6/28/2021 and 7/19/2021. This was reviewed by our Clinical Pathway teams that is comprised of our Infectious Disease provider who instructed per CDC guidelines autologous stem cell transplant to do not meet criteria per to restart the series unlike Allogenic Stem Cell Transplants. Patient notified and was deferred from getting a 5th dose as a booster to his 2 series of vaccine. Patient had NO adverse event from restarting the series, but this was a reportable event due to the error in restarting the series under the advisement of two physicians but does not align with CDC recommendations.
Pt recv vax on 8/5/98; 5.5 hrs later pt exp malaise and later fever of 103 degrees, shortness of breath, stomach ache.  Pt went to E.R.  Pt tx=Tylenol, Benadryl, fluids.  On 8/6/98 pt still had fever w/ vomitting.
This spontaneous report as received from a 24 year old female consumer. Patients concurrent condition and medical history were not reported. On an unknown date, the patient received the first dose of GARDASIL, dose unspecified, without experiencing any adverse effects. On an unknown date, the patient had received second dose of GARDASIL, dose unspecified without experiencing any adverse effects. Concomitant therapy was reported as none. It was reported that the patient had a enquiry regarding to have shoulder surgery within days of receiving her upcoming third (3rd dose) and final dose of GARDASIL. Consumer was inquiring on how it will affect the efficacy of GARDASIL administration. The patient did not seek medical attention. No product quality complaint involved. The outcome event was unknown. The reporters causality assessment for the event with the therapy of GARDASIL was unknown. Additional information has been requested.