chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Autoimmune Encephalitis 12/3/2015 after ER visit and subsequent admission. Symptoms since 11/22/2015 included profound fatigue; difficulty comprehending verbal and written language; personality changes; memory disturbances; sleeping disturbances; agitation; poor appetite; abnormal EEG; delusions. Treated with high dose steroids, IVIG and DEPAKOTE. Discharged from hospital 12/7/2015 on DEPAKOTE and ATIVAN. Missed 5 weeks of school. Returned to baseline health. Admitted with relapse August 11/2017 after ER visit and symptoms for 5 days similar to initial presenting symptoms. Received high dose steroids and IVIG. Discharged and to receive IV transfusions of Rituximab on an outpatient basis.
MODERNA COVID VACCINE 1ST DOSE WAS GIVEN TO PATIENT ON 02/26/21 ( FORM ALREADY FILLED ON 02/26/21). PATIENT AGE IS 13. APPROVED AGE FOR MODERNA COVID VACCINE IS 18.  PARENTS STATED THAT PATIENT  HAD NO REACTIONS OR ADVERSE EFFECTS FROM THE 1ST DOSE.  PER GUIDELINE, 2ND DOSE NEED TO GIVEN AS WELL.  THIS FORM IS FOR THE 2ND DOSE GIVEN ON 03/26/2021.
Initial unsolicited report received from a consumer on 13-FEB-2017. This case involves a 20-year-old female patient who was vaccinated intramuscularly with a third dose of IMOVAX (Lot number, expiry date, dose were unknown) in an unknown side (reported as right) on 20-JAN-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were reported as denies. Any other vaccinations within four weeks of vaccinations were also reported as denies. Concomitant medications were reported unknown. On an unknown date following initial vaccination, the patient experienced severe flu like symptoms, arthralgia, fever (highest recorded temp 102), then with second vaccine she experienced numbness and tingling in throat and following third vaccine on 20 January 2017; she experienced "paralysis" of throat lasting 5-6 hours by which the patient was unable to swallow. The patient had received intramuscularly two previous doses of IMOVAX on an unknown date. The emergency visit to a doctor was not reported. laboratory investigation was reported as body temperature of 102 degree Fahrenheit and corrective treatment was not reported. The outcome of the event was reported as recovered. List of documents held by sender: none.
Great pains in all joints, wrists, shoulders, cervical & lumbosacral DJD, neck, bones, mental disorders, erectile dysfunction. Both rotator cuffs shattered. Gastrointetinal disorders. Cardiovascular disease. Can't sleep and subjected to many medications.  11/20/08-records received for DOs 6/2/08-DX:Major depressive disorder,recurrent, severe. Coronary artery disease. Percuntaneous cath with stent. Hypertension. Chronic back pain. Overweight. Hepatitis B.Male erectile disorder.Impaired fasting glucose. Hypertropy benign of prostate. Osteoarthrosis. Multipe joint pain since 9/92. Dizziness episodes since 1/94. Blurred vision since 8/93. Insomnia 5/91. Post Gulf War.
Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil and experienced flu-like symptoms for a couple of days after the vaccination. Subsequently, the patient recovered. Additional information has been requested.
There was not an adverse reaction to the vaccine.  The wrong vaccination was given to the patient.  The patient was supposed to receive Fluzone Quad but received Fluzone High Dose
Chills; Fever; Nausea; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 99.6 (Inconclusive) 99.6F.     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.   Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Outcome of the events updated to resolved. Patient declined further follow-ups
allergic reaction/allergy to the COVID-19 shot allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction/allergy to the COVID-19 shot allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness and pain about 5 inches below the injection site of left arm/ dull pain; Arm feels hot; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and skin warm. On an unknown date, the outcome of the pain in arm and skin warm were unknown.   It was unknown if the reporter considered the pain in arm and skin warm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. Within 2 to 3 hours after vaccination, the patient experienced soreness and pain about 5 inches below the injection site of left arm. The pain was more at night and arm felt hot. The whole arm felt like it was punched. The whole arm was sore and she felt the presence of soreness more when she massages the arm. There was also dull pain present on the arm when she slept on it. No further details were provided. The reporter did not consent to follow-up.
3 x 6 area on R flank (rash).  Shingles - prescribed Zovirax for treatment.  Fever 100.00 degrees in office 4/13/03 - child first came in office on 4/10/03 with first onset of rash. Pt is still on Rx and still has rash as of 4/14/03.
headache seems to be getting worse; Headache every day since then; A spontaneous report was received from a Healthcare Professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and three days later, she experienced headache every day since then which seem to be getting worse and tylenol does not work anymore.  The patient's medical history was not provided. Concomitant medications reported were Armour thyroid.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Lot# 022M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, she experienced headache every day since then which seem to be getting worse and tylenol does not work anymore. Treatment details included Acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  On an unknown date, the outcome of event(s) headache every day since then which seem to be getting worse and tylenol does not work anymore were unknown.; Reporter's Comments: Very limited information has been provided for the event at this time. Further information has been requested.
This is a spontaneous report from a contactable physician via Pfizer Sales Representative. This physician reported similar events for three patients. This is second of three reports. A 3-year-old male patient received the second dose of PREVNAR-13, lot number F24141, on 19Mar2012, at left thigh, intramuscular, Number of Previous Doses: 1. The following vaccinations were administered to the patient: DTAP, administered on 19Mar2012, Lot # PENTACEL (C4059AA), at left thigh, intramuscular, Number of Previous Doses: 1, 11Jan2012, IPV, administered on 19Mar2012, Lot #/ Expiration date: PENTACEL (C4059AA), at left thigh, subcutaneous, Number of Previous Doses: 1, on 11Jan2012. MMR II, administered on 19Mar2012, Lot # 1001AA, at right thigh, subcutaneous, Number of Previous Doses: None. Varicella virus vaccine, administered on 19Mar2012, Lot # 1247AA, at right thigh, subcutaneous, Number of previous doses: None. Hepatitis B vaccine, administered on 19Mar2012, at left thigh. No relevant medical history was provided. On 20Mar2012, the patient experienced redness, pain, and feverish swelling across the entire upper thigh radiating up into the upper back, rash all over, left thigh swollen and hot, and fever. The patient was referred to the treating physician on 20Mar2012 and was prescribed BENADRYL for swelling and rash. The patient recovered from all the events on 24Mar2012. The physician considered PREVNAR 13 as the only suspect product. Follow-up (24Apr2012): New information from a contactable nurse reported on behalf of physician includes: Vaccinations details, event outcome.
Pt had erythematous patchy rash on face, back, and a few on extremities. Also had erythema around the site of HIB vaccine.
Chills, increased urination Narrative: Patient reported chills, increased urination and nausea after receiving the vaccine. No intervention was needed and symptoms subsided by the next day.
Body Aches returned about 4 months after 2nd shot; Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot) and MYALGIA (Body Aches returned about 4 months after 2nd shot) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MYALGIA (Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot) (seriousness criterion hospitalization). On 01-Feb-2022, the patient experienced MYALGIA (Body Aches returned about 4 months after 2nd shot) (seriousness criterion hospitalization). At the time of the report, MYALGIA (Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot) had resolved and MYALGIA (Body Aches returned about 4 months after 2nd shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, Pt took 2 doses of Moderna COVID-19 vaccine. First dose: 5 months ago (Lot# and Exp. Date: Unknown) and 2nd shot 4 months ago (Lot# and Exp. Date: Unknown). After the second dose(4 months ago), Pt had body aches. He went to the hospital and was told that it is vaccine related. About 10 days ago, the body aches returned. Pt was healthy prior to vaccination and not had medical history of any type of disease.  Concomitant medication was not provided Treatment information was not reported.  Company comment:This case concerns  a 24-year-old male patient  with no medical history, who experienced the serious events of Myalgia (2 episodes). The first episode occurred in the same month the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The second episode of Myalgia occurred approximately 4 months after his second dose. The patient was hospitalized and was told it was vaccine related.).The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This case concerns  a 24-year-old male patient  with no medical history, who experienced the serious events of Myalgia (2 episodes). The first episode occurred in the same month the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The second episode of Myalgia occurred approximately 4 months after his second dose. The patient was hospitalized and was told it was vaccine related.).The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
A report has been received from a Health Professional concerning a 1 year old, female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient received QLAIV (intranasal) on 18-Nov-2014. It was reported that there was an unintentional medication error by a physician who dispensed in a clinic setting the FLUMIST vaccine to the wrong patient population (under 2 years of age). The outcome of the event of wrongful administration was unknown. The reporter assessed the event of wrongful administration to be non serious. The reproter as well as company physician considered no causal relationship between event and reported suspect drug.
I had a fever, and chills for 48 hours, and a very sore arm that got a little better after a few days, but never completely went away.  The pain at the injection site  has been intensifying more and more, spreading now down to my wrist, and up to my neck, and is limiting my mobility to do the simplest of tasks without severe pain.  I have been on Hydrocodone from a fall that blew out my L-4 vertebrae three years ago, and even the Hydrocodone is not helping relieve the increasing pain.
Pfizer-BioNTec COVID-19 Vaccine EUA On the evening of the vaccine I started breaking out in a red itchy rash. It started at the base of my back/tailbone area. I developed a fever running slightly over 100. The fever lasted about 24 hours. The rash spread in disconnected blotches to other areas on the buttox, then toward the left side. The rash continues to break out in small blotches on the right inner leg. I am taking OTC Benadryl and using OTC Hydrocortizone 1% cream. The original area of outbreak seems to be healing but still present. Other secondary breakouts are about healed. I am continuing with the medications stated to control the itch.
Left arm swollen and large red area and itchy. Treat,emt  Trying ice and tylonal. still using this treatment as of 3/2/2021
I started to experience some dizziness, only when I would lay down.  I was prescribed Naproxen, but it didn't help. This lasted for about 6 weeks. One day it was completely gone.
Developed spontaneous ecchymosis large 10inx 10in , of left chest. Patient felt good. no symptoms. nontender. no history of trauma on 4/12- came in to the doctor 4/14
body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     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 MYALGIA (body ache). At the time of the report, MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
full hives/uticaria starting 4 days after 2nd shot; mild rash after 1st shot (Pfizer covid vaccine)  Treated with antihistamines & steroids
Aseptic meningitis, prolonged fever for more than a week, headache, elevated transaminase (ALT is 124). Lumbar tap showed elevated WBC  of 23,  76% polys and  24% mononuclear, 25 RBC. Glucose and protein are normal. CSF PCR viral panel is negative. Patient was initially given Acyclovir and was stopped when HSV and VZV PCR were negative. He was given vancomycin IV for Gram positive bacteremia which was later stopped because it was deemed a contaminant.
Pt recvd 3 doses of Engerix-B on 5JAN90, 3FEB90, & 26JUL90 for antibody protection against Hep B; 5JUN91 HBSAB RIA resulted as neg;
Painful swelling of cervical lymph node chain and supraclavicular lymph node. Isolated to the left side. First noticed around 12 hours after administration of influenza vaccine.
Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PRODUCT EXPIRATION DATE ISSUE (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021). On 18-May-2021, PRODUCT EXPIRATION DATE ISSUE (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: event was updated
body aches; fever; profuse sweating; fatigue; This is a spontaneous report from a contactable consumer(patient). A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly administered in Deltoid Right on 16Feb2021 at 14:45 (age at vaccination 57-years-old) (Batch/Lot Number: EL3247) as dose 2, single for covid-19 immunization. Medical history was not reported. Concomitant medication included atorvastatin calcium (LIPITOR) 20 mg taken for blood cholesterol taking from 10 plus years. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly administered in Right upper arm on 27Jan2021 (age at vaccination:57 years) (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunization. On 16Feb2021 at 22:00, the patient experienced body aches, fever, profuse sweating and fatigue. The events were not treated. The events not resulted in emergency room or physician office visit. The patient was not hospitalized. The patient recovered from all events on 18Feb2021.  Follow-up attempts completed. No further information expected.
pain at injection site of 1st shot only, 4/10 pain that comes and goes above and below the injection site on the right arm (the site of 1st shot), still is continuing now.
got the flu; Initial information received on 02-Jan-2023 regarding an unsolicited valid non-serious social media case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced got the flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot, strength, formulation, dose, expiry date: Unknown) via unknown route in unknown administration site as prophylactic vaccination .  On an unknown date the patient developed got the flu (influenza) (unknown latency)  It is unknown if the patient experienced any additional symptoms/events Medication Details  It is unknown if there were lab data/results available  Action taken was unknown.  It was not reported if the patient received a corrective treatment for the event (got the flu).  At time of reporting, the outcome was Unknown for the event got the flu.
Moderna COVID-19 Vaccine EUA Large area of swelling, redness approximately 6" below injection site. Redness had a large, firm lump in the center. Skin was hot and very itchy, soreness, dizziness. Today (2-5-21) large lump in greatly reduced in size. Redness is still present. Burning sensation is less.
severe pain at injection site radiating to elbow. Duration was 72 hours.  Lightheadedness started 6 hours after injection and last 36 hours
Mother noted child to be shaking w/eyes rolled back in head - lasted approx 5 min - called ambulance and taken to hospital. Diagnosed w/febrile seizure.
Pain in her arm; Feeling very bad; She cant get up; Stabs all over the body; Dizziness; Diarrhea on and off; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-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 an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea on and off), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body), DIARRHOEA (Diarrhea on and off), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved and DIZZINESS (Dizziness) had not resolved. Not Provided          No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.