chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the second dose of the vaccine my son 24 hours after the vaccine. He looked terrible with an ashy color and he had a very sore throat. He had other flu-like symptoms but he said it was difficult for him to swallow. He still had a fever of 100.9 and it lasted until the fourth day. The following day it was not much better so we went to the doctor and all tests were negative. It was still sore until the fifth day and then it subsided. We tried some Tylenol and Ibuprofen and it helped the fever but not the sore throat. It has been six days and he is fully recovered.
Dose administered after 30 days use by date or after manufacturer date of expiry; The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after 30 days use by date or after manufacturer date of expiry) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K2-2A, 013M20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30 days use by date or after manufacturer date of expiry). At the time of the report, PRODUCT STORAGE ERROR (Dose administered after 30 days use by date or after manufacturer date of expiry) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Moderna vaccine lot 033K2-2A manufacturer expiration date was reported as 20-May-2022 and was taken out of freezer on 20-Apr-2022. There were 13 booster doses in 1 vial. The vial was initially stored in the refrigerator on 20-Apr-2022. Out of freezer expiration date was reported as 20-May-2022. The vial did not undergo any temperature excursions.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-575471 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-575471:Master case
I can hear my eyes move at times. It is not a continuous sound, but at times when I move them, I hear a sound like a maraca.  This started after my second dose but we weren't sure what the cause was. It eventually went away after a couple months but returned after receiving the booster.
On 5/25 mom noticed a few itchy bumps on patient's neck.  by 5/26 patient had >25 bumps all over body.  Pt's mom was given the following recommendations by phone:  cut patient's fingernails and use oatmeal baths.  Pt's rash worsened over the following several days and he was seen in urgent care on 5/31.
I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having numerous issues and was referred to the long term Covid clinic. Balance issues, wheezing, cough, palpitations, headaches, shortness of breath, extreme fatigue, high blood sugars, blood pressure dropped
Night of vaccine, headache. Next day, muscle and joint aches, shooting nerve pain in legs before getting out of bed some days. Low grade fever 12/30. On 12/31 felt normal. On 1/1 symptoms began to recur fever 101.3, with higher fever 101.6 1/2/2021 and 100.3 1/3/2021, on ibuprofen from morning each day. Chills and sweats daily. COVID19 rapid test 1/3/2021 is negative. Currently temp 100.3, muscle aches, dizziness and congestion continue, feels winded walking short distances.
Invalid dose of Hib vaccine administered, Hib vaccine, reconstituted with sterile water instead of Hib diluent, No adverse reaction noted
Fever of 102 degrees F, chills, body aches, extreme fatigue, headache, weakness. Started at 10pm 12/18/20 and ended at 10am on 12/20/20.
Chest pressure and moderate pain for days after each Moderna vaccine.  Recurred over 6 weeks thereafter.  Didn't seek medical help and seems to have self corrected but not sure...
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostatectomy 7 years ago" (unspecified if ongoing), notes: Other medical history: Prostatectomy 7 years ago. There were no concomitant medications. The patient had not taken other medication within 2 weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after 2 negative tests; Negative, notes: Tested positive after 2 negative tests; Positive, notes: Rebound 5 days after completing treatment. Tested positive after 2 negative tests; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took anti-viral (Paxlovid) for COVID 19 Treatment on 31Aug2022 and stopped on 04Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
left ear and neck rash breakout (shingles). pain and itching for 3 days
Formatting of this note is different from the original.  Arrival Date: 11/27/21 1304 MRN: 000000000896187  CSN: 180566856 HAR: 100011543056   EMERGENCY DEPARTMENT - General NOTE  CHIEF COMPLAINT  Chief Complaint  Patient presents with  ? Rash  ? Flu Symptoms   HPI  The nurses note was reviewed, agreed and appreciated male who presents to the emergency room with complaints of generalized body aches, fever a couple days prior and rash. Patient reports that he recently got his COVID-19 booster last Sunday and developed symptoms a couple of days later. Patient reports waking up on Thursday morning having diffuse abdominal pain which prompted his emergency room visit at Hospital with complete work-up and was told that it appeared to be a virus. Patient reports he is continuing to have discomfort in his abdomen with no associated nausea or vomiting. He reports the pain is a burning sensation and currently rates his discomfort a 2 out of 10. Reports he is taking Vicodin with symptomatic control. Patient reports that he called a friend of the family,who recommended he come in for outpatient blood work. Patient reports he attempted to go to outpatient lab however they were closed and recommended he come to the emergency room to have his blood drawn. Patient denies any worsening symptoms however they are not getting better. Denies chest pain, shortness of breath, trouble breathing, lightheadedness or dizziness. Denies any change in bowel or bladder habits. Denies any worsening of his rash. Denies any exposures to anybody with similar symptoms
headache, has migraines, fever-98.6-99.9, chills, ear pain, sinus congestion, nasal congestion, post nasal drainage, sneezing, itchy eyes. starting 1/18/2022
After receiving her Hep A and then her Flu vaccine, pt fainted and went stiff (Flu vaccine needle still in arm when reaction occurred). Pt.'s body was in a state of hypertonicity initially and a few seconds later she went limp. Cam to after approx 30 seconds. Was pale and c/o numbness in hands and feet. Five mins or so after, developed vomiting. Vital signs were stable. Color eventually returned to her face; hands stayed pale for some time. Pt was taken by EMS to ED for further evaluation.
sick with the flu for 10 days; Initial information received on 13-Nov-2022 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves patient of unknown demographics who experienced sick with the flu for 10 days while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On unknown date in October 2022 (last month), the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination.  On unknown date in 2022, the patient got sick with the flu for 10 days (influenza) at unknown latency following the administration of INFLUENZA VACCINE.  It was reported that "the following potential adverse event has been found on a public post. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Got mine last month and have been sick with the flu for 10 days."   Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event sick with the flu for 10 days.
Per Daughter, blood in urine, body pain (lasted 2 days),  UTI (treated with cephalexin)
Pt developed rash on face and subsequently spread to trunk.  Some of rash was vesicular and in various stages.  The rash started one wk after the vaccine also asso with fever (101) and congestion and coryza.
elevated blood pressure that has required increasing his blood pressure medication dosage x4 (10mg to 40mg), continues to this date and had to add additional antihypertensive at today's visit.  he did not receive vaccination at our facility but did follow us remotely and now in person for the changes to his blood pressure.  we are continuing to monitor his blood pressure. he received his second dose 9/22/21 with no significant changes - just continued to have uncontrolled blood pressure resistant to lisinopril that previously controlled his blood pressure
Chills; 102 degrees temperature; Lethargic; Achy; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Apr2021 at 19:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications were not reported. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient body temperature was measured and the result was 102 degrees. On 07Apr2021 at 00:00, the patient experienced chills, 102 degrees temperature, lethargic and achy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event.  The clinical outcome of the event chills ,102 degrees temperature, lethargic and achy was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Got COVID".  Additional information: Patient got COVID this fall in Oct2022. He had no reactions to the COVID shots.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHEST CONGESTION; FELT SOMETHING BAD IN HER HIP KNOTS UNDER HER SKIN; NOT FEELING WELL; FEVER AND CHILLS; JOINT PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest congestion, felt something bad in her hip knots under her skin, not feeling well, fever and chills, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the joint pain, chest congestion, felt something bad in her hip knots under her skin, not feeling well and fever and chills was not reported. This report was non-serious.
Chills, fever, body aches, fatigue, nausea, horrible taste that continues, body odor change, urine and feces have peculiar odor, that also continues.
Information has been received from a physician concerning a 19 year old female with no medical history and drugs allergies, who on 06-AUG-2007 was vaccinated with a first dose of GARDASIL (lot# 658558/1061U). The patient received a second dose of GARDASIL (lot#658558/1061U) on 10-NOV-2007 and a 0.5mL third dose of GARDASIL (lot # 659657/1487U) on 06-MAR-2008, intramuscularly. Concomitant therapy included NUVARING. On 21-MAR-2009 the patient tested positive for a "high risk" strain of HPV. The exact strain was not identified. The patient had a Pap smear a reflex HPV testing and a DNA HPV probe. The patient had not recovered. Additional information has been requested.
Information has been received from a registered nurse concerning a child who on an unspecified date was vaccinated with a second dose of VARIVAX (lot # was not available). The nurse stated that the patient developed a rash within 5-7 days after receiving VARIVAX. It is not known if the rash was a varicella rash. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested. This is one of several reports received from the same source.
16yo received adult dose; 16yo received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 12th June 2022, the patient received Havrix adult. On 12th June 2022, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The reporter stated that one or two month ago, a patient received Havrix adult dose by error. The reporter give consent to follow up by email. Additional Supportive Information: The patient received Havrix adult dose by error, which led to overdose and adult product administered to child.
Chills; mild fever between 98.5 and 99.5; increased pulse of a little over 100 bpm; muscle soreness - at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 31st December 2020, 3 hrs after receiving Shingrix, the patient experienced injection site muscle pain. In January 2021, the patient experienced chills, fever and pulse increased. In January 2021, the outcome of the injection site muscle pain, chills, fever and pulse increased were recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, chills, fever and pulse increased to be related to Shingrix.  Additional details were reported as follows: The patient sated that a few hours later he experienced muscle soreness on his left arm at the injection site, which was not unusual after receiving an injection.  The reporter stated 12 hours after he experienced chills that resolved overnight, 14 hours after mild fever between 98.5 and 99.5 and an increased pulse of a little over 100 bpm.  During the day on 1st January 2021 a mild fever of pulse or minus one degree from normal and by midnight that evening all adverse reactions had resolved.  The reporter did not consent to follow-up.
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient developed mild symptoms of autism. At the time of this report, the outcome was unknown. The patient also experienced diarrhea while on therapy with ROTATEQ (MSD) (WAES 0902USA03976). No further information is available.
Vaccine caused a flare up with my Myasthenia Gravis which is an auto immune disease. Drooping of my eyes, severe muscle weakness, my swallowing was affected and speech difficulty. Muscle weakness of my arms and back. I was put on steroid medication, IV immune infusion for five days.
muscles were damaged; blood test value in 430; oxygen went down to 73; inflammation on her back; fatigue/fatigues when she drives/fatigues when she goes down the stairs/blood test value in 430; headache; agitated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AGITATION (agitated), MUSCLE INJURY (muscles were damaged), BLOOD TEST ABNORMAL (blood test value in 430), OXYGEN SATURATION DECREASED (oxygen went down to 73) and INFLAMMATION (inflammation on her back) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) for Menopause, PANTOPRAZOLE and VITAMINS NOS for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AGITATION (agitated) and HEADACHE (headache). On an unknown date, the patient experienced MUSCLE INJURY (muscles were damaged), BLOOD TEST ABNORMAL (blood test value in 430), OXYGEN SATURATION DECREASED (oxygen went down to 73), INFLAMMATION (inflammation on her back) and FATIGUE (fatigue/fatigues when she drives/fatigues when she goes down the stairs/blood test value in 430). The patient was treated with IBUPROFEN at an unspecified dose and frequency and NAPROXEN for Inflammation and Back pain, at a dose of 500 mg twice a day. At the time of the report, AGITATION (agitated), MUSCLE INJURY (muscles were damaged), BLOOD TEST ABNORMAL (blood test value in 430), OXYGEN SATURATION DECREASED (oxygen went down to 73), INFLAMMATION (inflammation on her back), FATIGUE (fatigue/fatigues when she drives/fatigues when she goes down the stairs/blood test value in 430) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) abnormal. On an unknown date, Oxygen saturation: 73 (Low) 73. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient visited her therapist and physical therapist   This case was linked to MOD-2021-214683 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up information received on 05-Jul-2021 contains updated reporter information added the treatment drug and updated the outcome of the events.
broke out w/rash on 17DEC97 dx w/thrombocytopenic purpura on 19DEC97 hosp;platelet count low since vax;had bone marrow aspiration & treated w/steroids;
Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022; Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 prophylaxis.     It was unknown if patient had ever diagnosed positive with Covid-19.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before.  Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included METFORMIN HCL, LISINOPRIL and METOPROLOL for an unknown indication.    On 02-Jun-2022 at 8:10 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Jun-2022 at 8:10 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was reported as 21-Jan-2022. Number of doses/vials was reported as 5 vails. The vial did not undergo any temperature excursions.  The vials used was kept in the refrigerator on the same day of their administration (2-Jun-2022).  Treatment information was not reported.     Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Follow-up was received and included no new information. On 23-Jun-2022: Follow-up received contain significant information include additional reporter details, patient demographics, relevant medical history, suspect product coding, dosage information, concomitant medications, event onset time and narrative updated.