chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to Emerg Dept with fever, chills, mental status change, headache, myalgia and left arm neuralgia pain; symptoms with 24 hours of vaccination. (hx mild flu symptoms with influenza vaccine).
Pt. fainted after receiving vaccines and was difficult to arouse. BP undetectable, sweating profusely, respirations labored. ER squad transported to ER.
PATIENT CAME IN TO GET COVID VACCINE, AND AFTER ADMINISTRATION UPON ENTERING THE VACCINATION INTO facility, WE NOTICED IT WAS REPORTED THAT HE HAD ALREADY RECEIVED BOTH DOSES OF PFIZER PREVIOUSLY IN THE YEAR. WHEN ASKED ABOUT THOSE VACCINATIONS HE CLAIMED HE HAD NOT BEEN VACCINATED PRIOR. WE WERE NOT ABLE TO GET ANY INFORMATION FROM THE VACCINATION SITE OF HIS PREVIOUS DOSES, SO WE ARE UNSURE WHICH DOSE THIS TRULY WAS.
Fever of 100.5; extreme body aches including skin, hips, and legs; headache; extremely sore arm from shoulder to elbow; fatigue  Took ibuprofen at 11:30am which helped relieve body aches and break the fever. Continued with ibuprofen throughout afternoon and evening to help with body aches that would came back to a lesser degree . Fatigue lasted throughout the afternoon and evening.   All symptoms were completely gone by about 10am the following day.
No adverse events.  Medication error - Patient was given an additional booster dose when not eligible.
No additional adverse event; Extra dose administered; Gardasil 9 1st dose administeren on 27-JUL-2018, 2nd on 16-AUG-2019 and 3rd on 21-AUG-2020; This spontaneous report as received from a Registered Nurse referring to a 12 year old patient (currently 14 year old) gender not reported. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 27-JUL-2018,  the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 26-AUG-2019 (inappropriate schedule of product administration), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On  21-AUG-2020, the patient received an additional third dose (extra dose administered ) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # S020254 that expires on 09-DEC-2021, for prophylaxis (dose, route of administration and administration site date were not reported).  No additional adverse event was reported. 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: S020254; expirationdate: 08-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient developed shortness of breath and irregular heart beat 8 days after receiving immunization.  Presented to the Clinic and was sent to the Emergency Department for evaluation.  Admitted for PE, NSTEMI, and afib with RVR 2/11/21.  Discharged to home 2/12/21.
At first my mother had a headache. Then My mother was feeling weak and could not breathe.  She continued to suffer so went to the doctor to get a check up but continued to suffer and finally died on 2/8/21 due to a couple of reasons which include hypertension
One Inch Diameter Oval Bruise around Injection Site which is Yellow, Blue and Red Blood Shots. It happened almost week after. Arm is still very sore. Sometimes throwing sensations. No fever. No chills. Can't see any swelling. Still Bruised up and Bloody spots around in the oval shape around injection site.
Pt reported to pharmacy on 12-20-18 stating that two days after her flu vaccination she experienced pain in her left shoulder which did not subside. Two weeks after the injection she was started on Prednisone, and is currently undergoing physical therapy to left bursa injury.
This case was reported by a nurse and described the occurrence of ocular stinging in a 37-year-old female patient who received ENGERIX B (batch number 53P39, expiry date 12th February 2020). On an unknown date, the patient received ENGERIX B. On 2nd October 2017, immediately after receiving ENGERIX B, the patient experienced ocular stinging and inadvertent exposure to vaccine. On an unknown date, the outcome of the ocular stinging and inadvertent exposure to vaccine. On an unknown date, the outcome of the ocular stinging and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the ocular stinging to be related to ENGERIX B. Additional details were reported as follows: The age at vaccination was not applicable for this report. While administering ENGERIX-B, the needle cracked and the vaccine squirted out of the syringe. The vaccine went into the nurse's eye, which led to inadvertent exposure to vaccine. The nurse had stinging in her eye for which she flushed her eye as treatment. This case was linked to case US2017GSK152218, reported by same reporter.
Patient in Office for, rash on face for 3days. Some pustules on arms as well.
Information has bene received from a certified medical assistant concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 03-MAR-2015 the patient was vaccinated with VARIVAX (Merck), subcutaneously (dose, strength, frequency and lot number were not provided) which was improperly stored (Incorrect product storage). Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Arm very sore for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm very sore for 5 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Seasonal allergy and Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm very sore for 5 days). On 20-Oct-2021, PAIN IN EXTREMITY (Arm very sore for 5 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-392686 (Patient Link).
mom noticed redness & swelling on rt upper arm extending from shoulder to elbow on the day p/vax; areas was very hot & hard as a rock; 1wk later t102-103 treated by MD 15JUL95 w/ATB inject followed by oral ATB x 5 days;
Patient states she felt like she had red hot peppers in her throat, fever, chills, cough and weakness.
severe skin delay hypersensitivity that wakes up with itchy rashes and hives all over the body daily. Uncontrolled with over-the-counter allergy medications such as Allegra, and prescription such as  hydroxyzine 25 mg QD, prednisone 20 mg QD, triamcinolone 0.5%, and fluocinonide.
Local reaction to arm injection site, warm, red, swollen around injection site 2x3 inches.
This is a serious spontaneous case, initially received from other health professional on 31-Jan-2018, concerning a 57-year-old adult female patient. The patient's historical vaccine included FLUCELVAX QIV (administered on 16-Nov-2016, dose: 0.5 mg, route of administration: intramuscular, anatomical location: right deltoid, batch number: 185246 and expiry date: 30-Apr-2018). On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195210, expiry date: 31-Mar-2018). On 23-Jan-2018, 3 months 28 days after vaccination, nasal swab was performed, and the patient was tested positive for influenza B virus (considered as, vaccination failure). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QA (Quality assurance) investigation reference number was 1027753. Based on the investigation performed, it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the fill finish or bulk manufacturing process and no trend was identified for the batch. Therefore, no internal root cause was confirmed. The patient had recovered from the event (flu). It was reported that patient did not require any hospitalization. Non-significant follow up received from the reporter on 10-Feb-2018: QAIR reference number (1027753) was added. Narrative amended accordingly. Follow-up QA (Quality assurance) investigations report received on 26-Mar-2018: Added expiry date 31-Mar-2018 in the product tab. Based on the investigation performed, it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the Fill Finish or Bulk manufacturing process and no trend was identified for the batch. Therefore, no internal root cause could be confirmed. The narrative was amended accordingly. Follow up report received on 02-Apr-2018: The patient's date of birth was added. The patient's historical vaccine (FLUCELVAX QIV) was added. The dose, route of administration, anatomical location of the suspect vaccine was added. The patient's lab data (nasal swab test) was added and reported that, influenza type B was confirmed. The outcome of the event influenza was updated from not reported to recovered. The narrative was amended accordingly. Update on 04-Jul-2018: Non-significant case correction was performed 26-Mar-2018: Case comment was corrected. No changes were made in the narrative.
redness and slight swelling at injection site, with some warmth at the arm. began 8 days post vaccine
fine pinkish mauclar papular rash over entire body started 24 hrs ago;
Mild Tinnitus persisting in 10/12/2022 at time of report.  Nausea and vomiting that started 10/11/2022.  Fever in excess of 100 degrees.
itchy red rash appear at various location throughout body. Started 2 days after vaccine. Day six itching still present but the intensity has reduced. treatable with over the counter calamine lotion.
Client began noticing spots under breasts and on back on Left side of body the day following vaccination. Complained of itching to these areas. No other symptoms, fever or pain.
variant of h1n1; Initial information received on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who had variant of h1n1 while receiving vaccine INFLUENZA VACCINE.  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 number not reported in unknown administration site.  On an unknown date the patient developed a non-serious variant of h1n1 (h1n1 influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (variant of h1n1).  At time of reporting, the outcome was Unknown for the event variant of h1n1.
Sever body aches, fever, chills, low energy and now 4 days later a right earache with slight throat discomfort on the same side and mild fever.
12/29/2020- received Moderna vaccine- felt mild tingling sensation in gums that resolved in 15 min Jan 2 - Mild itchiness to injection site with soreness Jan 7 - itchiness in throat and felt a lump in throat, also noticed tingling in gums Symptoms have resolved after taking over the counter medication
Patient was admitted to hospital on 12/22/2021 for one night.  Patient had developed pneumonia and had an abnormal chest xray.  Her symptoms were feverish, cough, shortness of breath and fatigue.  Patient's chart indicated type 2 diabetes, hypertension and severe obesity. She works in a Dr's office.
serum sickness, w/macular raised rash of buttocks & arms-evolved to polymorphous rash on trunk & extremities, face w/some central clearing w/occasional pruritus;also devel swelling of both knee w/effusion & puffiness of ankles;abd pain, eme
Exhausted; stomach cramps; gassy; diarrhea; headaches; sweaty; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 16Mar2021 at 1345 as a single dose for COVID-19 immunisation. Concomitant medications taken within two weeks of vaccination included gabapentin (MANUFACTURER UNKNOWN), rosuvastatin calcium (MANUFACTURER unknown) and sertraline (MANUFACTURER UNKNOWN) and hydroc ( MANUFACTURER UNKNOWN ) all since an unknown date. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 02Feb2021 at 1245, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and also did not receive any other vaccine within four weeks of vaccination. The patient had undergone nasal swab, COVID-19 quick test on 07Dec2020 and tested negative. Since the vaccination, patient had not tested for COVID-19. On 16Mar2021, the patient experienced exhausted, stomach cramps, gassy, diarrhea, headaches, sweaty and sore arm. The clinical outcome of all events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT WOKE UP WITH TERRIBLE PAIN IN THE LEFT EYE. WENT TO SEE EYE DOCTOR AND DOCTOR TOLD PATIENT HE HAD HERPES IN HIS EYE. DOCTOR GAVE PATIENT EYE DROPS
Tinnitus showed up a few days after vaccination and has gotten worse. Constant ringing in ears and chirping sounds.
I had covid in April 2020 and about 12 hours after the shot I experienced symptoms such as body aches, chills, restlessness, couldn?t sleep, headache and nausea.  Similar to when I had covid
During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation; Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms; Bad allergic reaction to the Moderna vaccine; Patient feels tired/tired that she couldn't go to the car to get the card; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation), RASH (Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms), ALLERGY TO VACCINE (Bad allergic reaction to the Moderna vaccine) and FATIGUE (Patient feels tired/tired that she couldn't go to the car to get the card) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (allergic to some medication).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSARTHRIA (During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation), RASH (Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms), ALLERGY TO VACCINE (Bad allergic reaction to the Moderna vaccine) and FATIGUE (Patient feels tired/tired that she couldn't go to the car to get the card). At the time of the report, DYSARTHRIA (During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation), RASH (Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms), ALLERGY TO VACCINE (Bad allergic reaction to the Moderna vaccine) and FATIGUE (Patient feels tired/tired that she couldn't go to the car to get the card) had not resolved.            No concomitant medications reported.  Patient received the first booster dose.  Patient was historically on steroids but not anymore because it was affecting the heart.  It was reported that patient sought medical care. The day after the booster patient started to experience the symptoms.  No Treatment medication was reported.
Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01158) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to coconut and chamomile. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. 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 09Apr2021 at 12:00, the patient experienced fever and headache. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events fever and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
At the moment the patient has not reported any adverse effects and after the administration the required time was observed where no adverse effect was presented.
loss of taste; loss of smell; Still COVID-19 positive after first vaccine; sleep a lot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Still COVID-19 positive after first vaccine), AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SOMNOLENCE (sleep a lot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Flu like symptoms (had flu-like symptoms). Concurrent medical conditions included COVID-19 (Patient stated that she tested positive for COVID-19 four weeks prior to vaccination) since July 2021 and Diabetes.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced COVID-19 (Still COVID-19 positive after first vaccine). On an unknown date, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SOMNOLENCE (sleep a lot). At the time of the report, COVID-19 (Still COVID-19 positive after first vaccine), AGEUSIA (loss of taste) and ANOSMIA (loss of smell) had not resolved and SOMNOLENCE (sleep a lot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Tested positive four weeks prior to vaccination. On 29-Aug-2021, SARS-CoV-2 test: positive (Positive) Patient is still positive after vaccination. On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative - not detected.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow up document received on 06-SEP-2021 information included -relevant medically history were added. new lab result were added. additional events were  added.
Started feeling sick when outside in the sun, then felt nauseaus and needed to sit down, then eyes started rolling to back of head, unable to lift body, alternating between hot and sweaty and cold and shivering while still outside but in shade at this point, face ashen, lips lacked color, unable to respond to partner when he asked if I needed to go to urgent care or 911. I kept saying i needed to go home, so he called an uber to my apartment. Nose was running, blurry vision, unable to walk alone when uber came to pick me and partner up. Kept seeing black and white stars when trying to cross the road to uber. Once I got home, I had watery stool in my underwear and had to stay on toilet for 30 minutes for watery stool to pass. Then kept alternating between feeling cold and hot while under blankets. Slept for 5 hours. Then felt fine. On Sunday, slept for about 15 hours - 18 hours. Throat kept hurting. Today, Monday, feel better but throat feels like there is a lump in it.
Needle was not seated well on syringe.  When nurse pushed plunger, most of the vaccine leaked out from between needle and syringe. Nurse estimated patient received just a small fraction of the dose. We revaccinated with a full dose, in the same arm.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, therapy type recombinant human albumin (RHA), lot # N009773, expiration date 20-SEP-2018 (dose, route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 2 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved (PQC).