chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness the next day around lunch.  Fell on Saturday around 4pm and broke his femur.  Patient denies any local reaction
I started vomitting 22hours after my second shot.  That continued for 3 days till i took anti-nausea medicine.  I got 2 bags of fluids at an urgent care facility on 5/24. 5/25 I went to my local ER with severe chest pains.  Had an ekg, chest x-ray and blood work done.  All came back normal.  Was given a muscle relaxer and anti-inflammatory medicine to help with the discomfort.  4 months later im still experiencing random chest pains once in a while.
Information has been received from a physician concerning a 5 year old white male with no medical history and no allergies who on 07/22/00 was vaccinated in the right arm with a dose of varicella virus vaccine live (Lot # 631165/0712J).  There were no adverse events following prior vaccinations. In April 2003, the pt developed breakthrough varicella with less than 60 lesions. No medical attention was sought. Subsequently, the pt recovered.  No further information is expected.
arm itching a lot around the area; Fever; flu symptoms; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), VACCINATION SITE PRURITUS (arm itching a lot around the area), PYREXIA (Fever) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 07-Mar-2021, the patient experienced INFLUENZA (flu symptoms). 07-Mar-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm itching a lot around the area). On 08-Mar-2021, INFLUENZA (flu symptoms), PYREXIA (Fever) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PRURITUS (arm itching a lot around the area) outcome was unknown.            Treatment included something for headache and for Itchy. Concomitant medications were not provided.Action taken with mRNA-1273 in response to the events was not applicable.
Pt reported feeling nauseous, diaphoretic, dizzy immediately after receiving second dose of Pfizer vaccine around 1033. Per mother, pt looked pale and lips  were bluish in color. Ice pack was applied to back of neck, ice water, apple juice brought to patient. RN tried to take BP twice with VS machine and was unsuccessful, pt was sweating more than normal and could not keep eyes open. RN STAT was called immediately. VS were attempted again at 1043 reading the following 74/34 (45), HR 55, SpO2 98% on RA. RN Treatment nurse arrived and patient was placed on gurney and taken to nurse treatment room for further observation. Upon arrival, pt states he is feeling better and mother states pt's color and lip color has returned to normalcy. VS are taken  at 1052 - 101/53 (73) HR 65, SpO2 99% RA. Pt is now drinking apple juice on hospital bed.
METALLIC TASTE IN  MOUTH, ITCHINESS / RASH TO LATERAL APECTS OF TONGUE TOWARDS TONGUE'S APEX BEGINNING 1/30/2021 GENERAL MALAISE 2/2-2/3/2021; TEMP ON THESE DAYS 99.4 DEGREES AND 99.7 DEGREES RESPECTIVELY I TOOK ACETAMINOPHEN ON 2/2/2021 BENADRYL 2/4/2021 - ITCHINESS SUBSIDED POST (1) DOSE TONGUE RASH PERSISTS AT THIS TIME
Hives on hands and feet, mild hives elsewhere. Still in existence but lessened two days later. Took antihistamines.
He started developing rheumatoid arthritis symptoms. His blood work looked like RA; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RHEUMATOID ARTHRITIS (He started developing rheumatoid arthritis symptoms. His blood work looked like RA) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (He started developing rheumatoid arthritis symptoms. His blood work looked like RA) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (He started developing rheumatoid arthritis symptoms. His blood work looked like RA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work looks like RA.         No concomitant and treatment medications were reported. Patient had event after 6 weeks of vaccination.; Reporter's Comments: Company Comment This spontaneous case concerns an unknown-years-old male patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant AESI  of   Rheumatoid arthritis unknown days after a  dose of  mRNA- 1273 bivalent vaccine. On an unknown date his blood work looks like RA. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Patient experience worse pain than she has with previous vaccines with limited range of motion approximately 2 days after receiving the vaccine. Patient sought medical care and was diagnosed with inflamed tendon. She was prescribed high dose ibuprofen, which she never filled or ingested. She has had some improvement with physical therapy.
Flu like symptoms; My back started burning and it's been burning all day all night, I can't do anything; it was like fire; Sore throat; pain; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the Pfizer shot 2 days ago and started getting flu like symptoms maybe 10 hours later. Then about maybe 24 hours after that, the back started burning and it's been burning all day all night and can't do anything. Patient took couple of muscle relaxers (Treatment). It was just like fire (Intent: burning sensation). Patient also had a sore throat and headache. Patient doesn't know if this was common or not. Patient reported to be in so much pain. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Fu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms for 6 weeks after 1st shot of vaccine. The reporter gave permission to follow up.
Patient received FLUZONE vaccination on 10-9-11. Patient stopped back into pharmacy on 11-6-11 to report he experienced numbness in his arm about 4 days after receiving his flu shot. He went to hospital and received steroid. Numbness resolved after 3 weeks.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  14-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number S008153 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I first noticed a sore throat on 4/16 that I attributed to the start of allergy symptoms. On Saturday, I began to get a headache and felt very lethargic. On Sunday, I was extremely lethargic and unable to leave my bed. I had no appetite, a headache, a sore throat, and a dry cough. My fever reached 101 degrees F. Monday morning I went to urgent care; I no longer had a fever but was still tired with a sore throat. As the week went on, my symptoms dissipated
Information has been received from a physician concerning a male who in approximately 1993 was vaccinated with a dose varicella virus vaccine live. Subsequently, the patient's titer for varicella is negative. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available at the time of the report. Additional information is requested.
positive for covid; injection site reactions; It hurt for like a day or two; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (positive for covid), INJECTION SITE REACTION (injection site reactions) and INJECTION SITE PAIN (It hurt for like a day or two) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031281) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (First dose (batch no. 010M20A)) on 16-Feb-2021, Moderna (second dose (batch no. 044AZIA)) on 27-Mar-2021, Moderna (Third dose (batch no. 013F21A)) on 11-Nov-2021, Moderna (fourth dose (batch no. 054A22A).) on 01-Jul-2022 and Moderna (fifth dose (batch no. AS7167B)) on 15-Dec-2022; for Product used for unknown indication: INFLUENZA VACCINE (Flu shot about 3 weeks ago). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Dust allergy.    On 13-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced INJECTION SITE PAIN (It hurt for like a day or two). On 19-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (positive for covid) and INJECTION SITE REACTION (injection site reactions). In October 2023, INJECTION SITE PAIN (It hurt for like a day or two) had resolved. At the time of the report, COVID-19 (positive for covid) and INJECTION SITE REACTION (injection site reactions) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Reported that patient received bronchial shot about 3 weeks ago. Concomitant medication reported as antidepressants.  Reported that patient had come down with a severe cold like 6 days later, does not felt so good. patient took a test at home, and it was positive for covid. Caller was gone to a pharmacy and got tested for it. patient has never had covid before. patient was not really feeling themselves. patient experienced some injection site reactions. It hurt for like a day or two.  No treatment medications were reported.
Stomach pain, nausea otherwise has felt well. No fever/vomit/headache/arthralgias/URI symptoms.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 52.40  Concomitant products were not provided.  On 06-APR-2021, the vaccine with batch number 044B21A was moved to fridge. On 15-APR-2021, 18  vials were moved to the clinic. On 15-APR-2021 at 9:00 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit.The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-MAY-2021. For batch number 044B21A, 188  doses given for the day. Temperature excursion for was reported for cooler 1 of the device it was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
45 minutes post injection called patient who reported 3/10 tightness in throat. Patient was able to vocalize reaction and sent to NP in employee health for further f/u. Angioedema.
I received my first Covid-19 shot on 02/19/21 on 03/23/21 I received my second shot. On 09/24/21 I developed shingles on my left side of my body (neck and shoulder). I have had no history of shingles and no other reason to have shingles at 28 years old. At the time of this report I still have scaring from the shingles on my neck and shoulder.
After receiving immunizations patient began feeling dizzy and passed out for approx. 60 second. After coming to, he drank some juice and remained seated for approx. 10 minutes before leaving.
36hr p/vax fever to 40.5, sz vs severe shaking chills had full sepsis w/u;
/Patient received the flu shot at the office at  10:30Am, at around 10:38AM patient started to feel dizzy and weak. Blood pressure was  checked 95/56 heart rate was 46 and glucose was 104. Juice was given and after a few minutes patient started to feel better, Heart rate went up to 55. Patient was discharge home after being on observation and feeling better.
pt recvd vax & w/in 15mins post vax pt became pale,& had a blank (expressionless) face,collapsed (passed out for 1mon) was disoriented,& weepy & nauseated (for a short period of time);probable vasovagal rxn unrelated to Engerix-B
SYMPTOMS STARTED ABOUT 3 WEEKS AFTER RECEIVING SECOND MODERNA VACCINE.  MONONUCLEOSIS WAS NOT DIAGNOSED PROPERLY UNTIL TWO WEEKS AFTER SYMPTOM ONSET.  SYMPTOMS INCLUDED: CHRONIC FATIGUE LISTLESSNESS NO APPETITE FEVER
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-OCT-2016, the patient was vaccinated with improperly stored ZOSTAVAX subcutaneously, lot # M030140, expiry date 18-AUG-2017 (dose and site of administration were not reported). No adverse effects were reported. Additional information is not expected, as there was no consent given to contact reporter.
Information has been received from an investigator concerning a 3 month old female. On 7/17/02, at 2 months of age, she received her first dose of Prevnar as part of a post-marketing safety surveillance trial. That same day, she also received first doses of DTaP, IPV, and ACT-HIB, with a second dose of Hep B. On 8/28/02, she was hospitalized with acute respiratory distress and a diagnosis of pneumonia was made. Later that day, the child expired due to A/V block complete, acute respiratory failure and heart failure with primary cardiomyopathy and other cardiac dysrhythmias, hypotension, acidosis, and other lung disorders. Resuscitation attempts were unsuccessful. The child's medical history consisted of diaphragmatic/phrenic paralysis with mechanical ventilation leading to chronic lung disease, meconium aspiration and pulmonary hypertension which required extracorporeal circulation membrane oxygenation, pylorospasm, and feeding problems which required feedings via N-J tube. The investigator's assessment of relatedness of these events (all except pneumonia, unexpected as per USPI) to the vaccines administered was *not related.* *Add'l info received as result of combining duplicate cases on 12/13/02 provided an investigator's assessment of NOT RELATED."*
- Day following the shot: headaches and dizziness. Difficulty to focus. - Whole week following the shot: cold feet and hands, Mild blood circulation problems (legs and arms slightly painful)
3/10/2021 at approximately 7 p.m. I noticed my gums, roof of mouth and inside bottom lip hurting when I was eating.  I discovered I had approximately 10 sores, similar feeling to a small blister or canker sore.
Over 04/24/2021 and 04/25/2021, c/o chills, goosebumps, headache, fatigue, intermittent hot and cold. 04/26/2021, symptoms previously resolved, but noted redness of approximately 4 inches round vaccination site on right arm. 1 inch dark red circle on outer edge of reddened area. Warm to touch. 04/27/2021, darkened red area over entire site and remains approximately 4 inches round. Continues to remain hard, swollen, warm to touch. Client counseled to contact physician for further recommendations.
1/15: Pfizer vaccine dose 1 administered 1/16: Fever, chills 1/22: Sore throat, coughing w/white phlegm, taking Tylenol and Mucinex.  Fever and chills from 1/16 subsided. Had telehealth consultation with PA. Per her notes, patient said he gets these symptoms annually, requested for an antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms do not subside.  1/23: COVID test administered 1/25: Reported positive for COVID 1/26: Telehealth session w/PA: she informed patient of his positive test, advised to quarantine and seek medical help at hospital if symptoms worsen. Patient reported that his sore throat mostly subsided but is still coughing at night. Said that the pharmacy didn't receive the prescription order for the antibiotic, so this was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed.  Death certificate issued by state says cause of death: COVID. Autopsy was not performed. Buried on 2/9/21.
Chills(moderate), HA(mild), muscle aches (severe), lightheadedness (moderate), fatigue (moderate) Resulted in leaving work at hospital early
Tested NAAT positive for COVID 10/5/21 after being fully vaccinated.
lightheadedness; vaccination site was inflammed; injection site was tender/ injection site was painful with pain scale of 6; fever with temperature of 100.2F and 103.2F; Body aches; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds, Allergy to animal dander and Pollen allergy. Concomitant products included OLOPATADINE and OLOPATADINE for Allergy, MULTIVITAMINS [VITAMINS NOS], L-THYROXIN [LEVOTHYROXINE], SIMVASTATIN, PREGABALIN and FLUTICASONE FUROATE (FLONASE SENSIMIST ALLERGY RELIEF) for an unknown indication.    On 30-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (lightheadedness), VACCINATION SITE INFLAMMATION (vaccination site was inflammed), VACCINATION SITE PAIN (injection site was tender/ injection site was painful with pain scale of 6), PYREXIA (fever with temperature of 100.2F and 103.2F), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100.2 (High) Fever with temperature of 100.2 F then at around 5:30 P.M it was 103.2 F. On 01-May-2021, Body temperature: fever was down to 100.8f (High) fever was down to 100.8F.     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.   The patient's concomitant also include an allergy pill (unspecified). The patient applied ice pack for 20 minutes on affected arm.